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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00500331




Registration number
NCT00500331
Ethics application status
Date submitted
24/01/2007
Date registered
12/07/2007
Date last updated
6/12/2017

Titles & IDs
Public title
Dose-Ranging Study in Treatment Naive Type 2 Diabetes Mellitus(T2DM)
Scientific title
A Double-blind, Randomized 12-week Study to Evaluate the Safety and Efficacy of GSK189075 Tablets vs Pioglitazone in Treatment Naive Subjects With Type 2 Diabetes Mellitus
Secondary ID [1] 0 0
KG2105255
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK189075
Treatment: Drugs - pioglitazone
Other interventions - Placebo

Experimental: Arm 1 - GSK189075

Placebo Comparator: Arm 2 - Placebo

Other: Arm 3 - pioglitazone (active control)


Treatment: Drugs: GSK189075
Experimental Drug

Treatment: Drugs: pioglitazone
Active Control

Other interventions: Placebo
Placebo Comparator

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline (Week 0) in Glycosylated Hemoglobin (HbA1c) (%) at Week 12 - Fasted blood samples for HbA1c were collected at Baseline and Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Only those participants with a value at Baseline and at Week 12 (after Last Observation Carried Forward [LOCF]) were used for this analysis. Adjusted mean is presented as least square mean.
Timepoint [1] 0 0
Baseline (Week 0) and Week 12
Secondary outcome [1] 0 0
Change From Baseline in HbA1c (%) at Weeks 4 and 8 - Fasted blood samples for HbA1c were collected at Baseline and Weeks 4 and 8. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [1] 0 0
Baseline (Week 0) and Week 4 and Week 8
Secondary outcome [2] 0 0
Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) at Weeks 4, 8 and 12 - Fasted blood samples for FPG were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [2] 0 0
Baseline (Week 0) and Week 4, Week 8 and Week 12
Secondary outcome [3] 0 0
Change From Baseline to Week 12 in Fructosamine - Fasted blood samples for fructosamine were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [3] 0 0
Baseline (Week 0) to Week 12
Secondary outcome [4] 0 0
Change From Baseline to Week 12 in Fasting Insulin - Fasted blood samples for insulin were collected up to Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [4] 0 0
Baseline (Week 0) to Week 12
Secondary outcome [5] 0 0
Number of Participants at Week 12 With: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 Mmo/L, FPG <7.8 mmol/L; FPG <5.5 mmol/L; a Decrease From Baseline of HbA1c >= 0.7%; a Decrease From Baseline of FPG =1.7 mmol/L - Fasted blood samples for HbA1c were collected at Week 12. Participants were required to fast for at least 8 hours prior to laboratory samples and were told not to take the morning dose of study medication on these visit days and to refrain from eating until instructed to do so by study personnel in the clinic. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Number of participants at Week 12 with: HbA1c <= 6.5%, HbA1c <7.0%; FPG <7 mmo/L (126 milligram/deciliter [mg/dL]), FPG <7.8 mmol/L (140 mg/dL); FPG <5.5 mmol/L (100 mg/dL); a decrease from Baseline of HbA1c >= 0.7%; a decrease from Baseline of FPG =1.7 mmol/L (30 mg/dL) are presented.
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Percent Change From Baseline in Lipid Parameters at Weeks 4, 8 and 12(Triglycerides [TG], Total Cholesterol [TC], Low-density Lipoprotein Cholesterol [LDL-C] and High-density Lipoprotein Cholesterol [HDL-C]) - Fasted samples for TC, LDL-C, HDL-C and TG were collected at Week 12. When the participant had not fasted, the participant was rescheduled to return to the clinic to have a fasted sample taken. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percent Change based on log-transformed data: 100*(exponentiated(mean change on log scale)-1)
Timepoint [6] 0 0
Baseline (Week 0) and Week 4, Week 8 and Week 12
Secondary outcome [7] 0 0
Change From Baseline to Week 12 in Body Weight - Weight of participants was measured from Baseline (Week 0) to Week 12 and recorded in the case report form (CRF). Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [7] 0 0
Baseline (Week 0) to Week 12
Secondary outcome [8] 0 0
Change From Baseline to Week 12 in Waist Circumference - Waist circumference of participants was measured from Baseline (Week 0) to Week 12 and recorded in the CRF. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [8] 0 0
Baseline (Week 0) to Week 12
Secondary outcome [9] 0 0
Change From Baseline in 24-hour Percent of Filtered Glucose Excreted in Urine - A 24-hour urine collection was obtained from all participants at Baseline (Week 0) and Week 12 to measure glucose. Participants were provided with urine collection bottles and cooler prior to these visits and instructed that the urine collections must be kept cold and dropped off at the clinic prior to or at the scheduled visits. Site staff queried participants to determine whether the sample represented a full 24-hour collection. The total volume and the sample date and time were recorded. The entire 24-hour urine collection was well mixed in one container and a urine aliquot obtained. Samples were assayed for glucose. The 24-hour collections were used to derive 24-hour urine glucose excretion corrected for filtered load. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [9] 0 0
Baseline (Week 0) and Week 12 (24-hour urine collection)
Secondary outcome [10] 0 0
Change From Baseline in Plasma Glucose Area Under the Curve (AUC) During a 2-hour Oral Glucose Tolerance Test (OGTT) - Post-prandial assessments of glucose were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time "0" started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [10] 0 0
Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)
Secondary outcome [11] 0 0
Change From Baseline in Insulin AUC During a 2-hour OGTT - Post-prandial assessments of insulin were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time "0" started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [11] 0 0
Baseline (Week 0) and Week 12 (0 to 2-hour OGTT)
Secondary outcome [12] 0 0
Change From Baseline in C-peptide AUC During a 2-hr OGTT - Post-prandial assessments of C-peptide were performed at Baseline (Week 0) and at Week 12 using a 2-hour OGTT in a subgroup of participants at selected sites who agreed to participate. Participants were required to fast for at least 8 hours prior to the test. Seventy-five (75) g of standard oral glucose solution was administered 15 minutes after the morning administration of study medication (Week 12) and in the place of breakfast at Week 0 (i.e., at Week 0 the OGTT was completed prior to administration of study medication). Time "0" started when the participants drank the glucose solution. Blood samples were collected at the following times relative to the administration of oral glucose: -30 min (pre-glucose), -20 min (pre-glucose), 20 min, 30 min, 1 hour, 1.5 hour and 2 hour post glucose administration. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [12] 0 0
Baseline (Week 0) and Week 12 (0 to 2 hour OGTT)
Secondary outcome [13] 0 0
Number of Participants With On-therapy Adverse Events (AE) and Serious Adverse Events (SAE) - AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Timepoint [13] 0 0
Up to 12 weeks
Secondary outcome [14] 0 0
Number of Participants With On-therapy Hypoglycemia - Hypoglycemia is low blood glucose or low blood sugar. Hypoglycemic events were collected separately and reported separately from AE, including supplemental data which were not collected for AE. However, any hypoglycemic event which met the criteria for a SAE was included in the SAE summaries. The number of participants in each group that experienced a hypoglycemic event was summarized by frequency of the events.
Timepoint [14] 0 0
Up to 14 weeks
Secondary outcome [15] 0 0
Number of Participants With Change From Baseline Vital Signs of Potential Clinical Concern - Vital signs included heart rate and blood pressure. Heart rate and blood pressure were taken before blood draws were performed. Participants were asked to refrain from smoking for at least 30 minutes prior to vital sign measurements. Heart rate and blood pressure was measured pre-dose in duplicate at the specified visits, after the participant had been lying quietly for 5 minutes, and then in duplicate 3 minutes after standing up. Heart rate was measured at the same time as blood pressure using the standardized blood pressure equipment that was provided. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [15] 0 0
Up to 14 weeks
Secondary outcome [16] 0 0
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern - Full 12-lead ECGs were recorded at screening, Baseline (Week 0), Week 4, Week 12 or early withdrawal, and Week 14 (Follow-up) using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT and corrected QT (QTc) intervals. All 12-lead ECGs were read locally by the Investigator or his/her designate and were forwarded electronically to the central reader for interpretation. If the QTc was >500 milliseconds (msec) on the locally read ECG recording, an additional 2 ECG recordings at 10 minute intervals were made at that visit. If the average QTc for the 3 recordings was >500 msec, the participant was withdrawn from the study.
Timepoint [16] 0 0
Up to Early withdrawal (Between Week 12 and Week 14)
Secondary outcome [17] 0 0
Number of Participants With Change From Baseline in Standard Laboratory Parameters of Potential Clinical Concern - Participants were instructed to fast for at least 8 hours prior to all study visits for the collection of laboratory samples. An additional fasting blood sample (serum and plasma) was drawn at Week 0, Week 4, Week 6 and Week 12 or at early withdrawal (up to 14 weeks) and kept in long-term storage for future testing of biomarkers for diabetes and complications of the disease. Baseline was Week 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Timepoint [17] 0 0
Up to 14 weeks

Eligibility
Key inclusion criteria
Inclusion criteria:

- Subjects with a documented diagnosis of T2DM and have an HbA1c level at Visit 1 of
=7.0% and =9.5% as measured by a central laboratory. Subjects with HbA1c <7.5% must
have a fasting fingerstick glucose =7 mmol/L (126 mg/dL) at Week 0 prior to
randomization.

- Subjects who are treatment-naïve and have not taken insulin, or any oral or injectable
anti-diabetic medication in the past 3 months and have not taken a glucose lowering
agent for =4 weeks at any time in the past, or Subjects who are newly diagnosed and
treated with diet and exercise for a minimum of 6 weeks

- Subjects who are 18 to 70 years of age inclusive at the time of Screening.

- Females of non-childbearing and childbearing potential are eligible to participate as
follows:

- Women of childbearing potential must be willing to use one of the following
contraception methods: intrauterine device, condom or occlusive cap (diaphragm or
cervical/vault caps) plus spermicidal agent for at least 30 days prior to the
start of study medication, throughout the study and the follow-up visit. Note:
use of oral contraceptives is not permitted.

- Women of non-child bearing potential are defined as follows: females regardless
of age, with functioning ovaries and who have a current documented tubal ligation
[Hatcher, 2004] bilateral oophorectomy or total hysterectomy, or females who are
post-menopausal).

(Post-menopausal is defined as after one year without menses with an appropriate clinical
profile, e.g. age appropriate, >45 years, in the absence of hormone replacement therapy. In
addition to the above criteria, if the post-menopausal status is still questionable, a
blood sample should be drawn for simultaneous measurement of follicle stimulating hormone
and estradiol; values considered to confirm the post-menopausal state are respectively: FSH
>40 MIU/mL and estradiol <40pg/mL (<140 pmol/L)).

- Informed Consent: a signed and dated written consent must be obtained from the subject
before any procedures are performed.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Metabolic Disease

- Diagnosis of Type 1 diabetes mellitus.

- History of ketoacidosis which has required hospitalization.

- Thyroid disorder [TSH below the lower limit of the reference range (LLRR) of
0.4mIU/L or above the upper limit of the reference range (ULRR) of >5.5 mIU/L at
Screening]. Hypothyroidism treated with the same dose and regimen of thyroid
hormone replacement for at least 3 months prior to Screening is allowed.

- BMI of <22 or >43 kg/m2.

- Significant weight gain or loss (as defined as >5% of total body weight) in the 3
months prior to Screening.

- Diabetic Medication

- Has taken insulin or any oral or injectable anti-diabetic medication =4 weeks at
any time prior to screening.

- Has taken insulin or any oral or injectable anti-diabetic medication within 3
months of screening.

- Cardiovascular Disease

- Recent history or presence of clinically significant acute cardiovascular disease
including:

1. Documented myocardial infarction in the 6 months prior to Screening.

2. Coronary revascularization including percutaneous transluminal coronary
angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery either
planned and/or occurred in the 6 months prior to Screening.

3. Unstable angina in the 6 months prior to Screening.

4. Clinically significant supraventricular arrhythmias requiring medical
therapy, or history of nonsustained or sustained ventricular tachycardia.
Symptomatic valvular heart disease or valvular heart disease requiring
therapy other than endocarditis prophylaxis.

5. Congestive heart failure (CHF, New York Heart Association (NYHA) Class II to
IV) requiring pharmacologic treatment. NYHA Class I may be included in
accordance with the local prescribing information for pioglitazone.

6. Blood pressure (BP) >150/100mmHg. If a subject is receiving permitted
antihypertensive therapy, then they must be on stable dose(s) of therapy for
at least 4 weeks prior to Screening.

7. Has a QTc interval (Bazett's) =450msec at Screening on a single ECG or an
average value from 3 ECGs taken 5 minutes apart (on local reading of ECG).

8. Other clinically significant ECG abnormalities which, in the opinion of the
investigator, may affect the interpretation of efficacy and safety data, or
which otherwise contraindicates participation in a clinical trial with a new
chemical entity.

- Fasting triglycerides =400mg/dL (4.56mmol/L) at Screening. If a subject is
receiving permitted lipid-lowering therapy, then they must be on a stable dose(s)
of therapy for at least 6 weeks prior to Screening. Niacin and bile acid
sequestrants are prohibited.

- Hepatic Disease

Has a diagnosis of active hepatitis (hepatitis B surface antigen or hepatitis C antibody),
or clinically significant hepatic enzyme elevation including:

Any one of the following enzymes greater than 2 times the upper limit of the reference
range (ULRR) value at Screening.

- alanine transaminase (ALT).

- aspartate transaminase (AST).

- alkaline phosphatase (AP). Has a total bilirubin level that is >1.5 times the ULRR at
Screening with the exception of suspected or confirmed Gilbert's disease.

- Pancreatic Disease

- Secondary causes of diabetes:

- history of chronic or acute pancreatitis

- Renal Disease

- Significant renal disease at Screening as manifested by:

Glomerular filtration rate (GFR) <60mL/min (as estimated from serum creatinine at Visit 1
and demographic data using the MDRD equation).For the MDRD equation, please refer to the
study procedures manual.

Proteinuria of =1+ by urinary dipstick

- Recurrent genitourinary tract infections defined as =2 episodes of complicated or
uncomplicated cystitis or pyelonephritis in the 6 months prior to Screening

- A positive qualitative urinary dipstick for leukocytes, red blood cells (RBC) or
nitrites at Screening.

- Concurrent Disease

- Has any concurrent condition or any clinically significant abnormality identified on
the screening physical examination, laboratory tests (including blood electrolytes),
electrocardiogram, including pulmonary, neurological or inflammatory diseases, which,
in the opinion of the investigator, may affect the interpretation of efficacy and
safety data, or which otherwise contraindicates participation in a clinical trial with
a new chemical entity

- History of significant co-morbid diseases active in the 6 months prior to Screening
(e.g., cholecystitis, acute pancreatitis, gastrointestinal disease, chronic diarrhea,
etc.)

- Has a history of malignancy within the past five years [other than superficial
squamous cell carcinoma which is non-invasive on pathology or basal cell carcinoma
which is successfully treated with local excision] and cervical cancer in situ treated
definitively at least 6 months prior to Screening

- Concurrent Medication

- Is currently taking or has taken any of the following medications in the 8 weeks prior
to Screening:

1. Digoxin

2. Warfarin and other oral anticoagulants (aspirin and non-steroidal
anti-inflammatory drugs are permitted)

3. Bile acid sequestrants

4. Niacin (excluding routine vitamin supplementation)

5. Antiobesity agents (including fat absorption blocking agents)

6. Oral or injectable corticosteroids (inhaled and intranasal corticosteroids are
permitted)

7. Loop diuretics

8. Monoamine oxidase inhibitors and tricyclic amines

9. Antiretroviral drugs

10. St John's Wort

11. Oral chromium

- Pregnancy & Breast Feeding

- Is currently lactating or pregnant

- Other

- Current smoker who is unable to abstain from smoking while in the clinic at each visit

- Has a history of alcohol or substance abuse within the past year at Screening or
alcohol or substance abuse during treatment, as determined by the investigator:

- Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated
restrictions while participating in the study.

- Has an average weekly intake of greater than 21 units or an average daily intake of
greater than 3 units (males) or an average weekly intake of greater than 14 units or
an average daily intake of greater than 2 units (females). One unit is equivalent to a
half-pint of beer or 1 measure of spirits or 1 glass of wine

- Has participated in any study with an investigational or marketed drug in the 3 months
prior to Screening

- In the opinion of the investigator has a risk of non-compliance with study procedures,
or cannot read, understand, or complete study related materials, particularly the
informed consent

- Known allergy to any of the tablet excipients, or history of drug or other allergy,
which, in the opinion of the responsible study physician

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New Mexico
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
Argentina
State/province [11] 0 0
Buenos Aires
Country [12] 0 0
Argentina
State/province [12] 0 0
Córdova
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Mendoza
Country [15] 0 0
Argentina
State/province [15] 0 0
Quilmes
Country [16] 0 0
Argentina
State/province [16] 0 0
Tucuman
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Pleven
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Plovdiv
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Varna
Country [21] 0 0
Chile
State/province [21] 0 0
Región Metro De Santiago
Country [22] 0 0
Costa Rica
State/province [22] 0 0
San José
Country [23] 0 0
Czechia
State/province [23] 0 0
Brno
Country [24] 0 0
Czechia
State/province [24] 0 0
Ceske Budejovice
Country [25] 0 0
Czechia
State/province [25] 0 0
Cheb
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Czechia
State/province [26] 0 0
Havirov - Soumbrak
Country [27] 0 0
Czechia
State/province [27] 0 0
Olomouc
Country [28] 0 0
Czechia
State/province [28] 0 0
Prague
Country [29] 0 0
Czechia
State/province [29] 0 0
Praha 5
Country [30] 0 0
Czechia
State/province [30] 0 0
Semily
Country [31] 0 0
Czechia
State/province [31] 0 0
Sumperk
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Czechia
State/province [32] 0 0
Usti nad Labem
Country [33] 0 0
Czechia
State/province [33] 0 0
Znojmo
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Germany
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Baden-Wuerttemberg
Country [35] 0 0
Germany
State/province [35] 0 0
Bayern
Country [36] 0 0
Germany
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Hessen
Country [37] 0 0
Germany
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Niedersachsen
Country [38] 0 0
Germany
State/province [38] 0 0
Nordrhein-Westfalen
Country [39] 0 0
Germany
State/province [39] 0 0
Rheinland-Pfalz
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Erd
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Hungary
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Gyor
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Hungary
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Miskolc
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Hungary
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Mosonmagyaróvár
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Hungary
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Nyirtegyhaza
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Hungary
State/province [48] 0 0
Pécs
Country [49] 0 0
Hungary
State/province [49] 0 0
Szentes
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Hungary
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Szigetvar
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Hungary
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Szombathely
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Hungary
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Veszprem
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Hungary
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Zalaegerszeg
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India
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Bangalore
Country [55] 0 0
India
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Kochi
Country [56] 0 0
India
State/province [56] 0 0
Mumbai
Country [57] 0 0
India
State/province [57] 0 0
New Delhi
Country [58] 0 0
India
State/province [58] 0 0
Pune
Country [59] 0 0
Latvia
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Jelgava
Country [60] 0 0
Latvia
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Limbazi
Country [61] 0 0
Latvia
State/province [61] 0 0
Riga
Country [62] 0 0
Latvia
State/province [62] 0 0
Talsi
Country [63] 0 0
Latvia
State/province [63] 0 0
Tukums
Country [64] 0 0
Lithuania
State/province [64] 0 0
Kaunas
Country [65] 0 0
Lithuania
State/province [65] 0 0
Vilnius
Country [66] 0 0
Mexico
State/province [66] 0 0
Baja California Norte
Country [67] 0 0
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Lima
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Lodz
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Porabka
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Wroclaw
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Ponce
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Brasov
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Roodepoort

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a dose-ranging study that will evaluate the efficacy, safety and tolerability of a
range of doses of investigational product and pioglitazone, compared to placebo, administered
as monotherapy over 12 weeks in treatment naive patients with T2DM
Trial website
https://clinicaltrials.gov/show/NCT00500331
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications