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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00395512




Registration number
NCT00395512
Ethics application status
Date submitted
1/11/2006
Date registered
3/11/2006
Date last updated
27/03/2013

Titles & IDs
Public title
Efficacy of Alogliptin With Pioglitazone (Actos®) in Subjects With Type 2 Diabetes Mellitus
Scientific title
A Multicenter, Double-Blind Study to Determine the Efficacy and Safety of SYR-322 Plus Pioglitazone HCl (Actos®), SYR-322 Alone or Pioglitazone HCl Alone in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
2006-005492-17
Secondary ID [2] 0 0
01-06-TL-322OPI-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 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 - Alogliptin
Treatment: Drugs - Pioglitazone
Treatment: Drugs - Placebo

Experimental: Alogliptin 25 mg QD - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.

Active Comparator: Pioglitazone 30 mg QD - Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.

Experimental: Alogliptin 25 mg QD+ Pioglitazone 30 mg QD - Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.

Active Comparator: Alogliptin 12.5 mg QD + Pioglitazone 30 mg QD - Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.


Treatment: Drugs: Alogliptin
Alogliptin tablets.

Treatment: Drugs: Pioglitazone
Pioglitazone tablets.

Treatment: Drugs: Placebo
Matching placebo tablets.

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 26 in Glycosylated Hemoglobin (HbA1c) - The change from Baseline to Week 26 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound).
Timepoint [1] 0 0
Baseline and Week 26
Secondary outcome [1] 0 0
Change From Baseline in HbA1c Over Time - The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at 4 week intervals during the study. Least Squares Means were from an Analysis of Covariance (ANCOVA) model with treatment and geographic region as class variables and baseline HbA1c as a covariate.
Timepoint [1] 0 0
Baseline and Weeks 4, 8, 12, 16 and 20.
Secondary outcome [2] 0 0
Change From Baseline in Fasting Plasma Glucose Over Time - The change from Baseline in fasting plasma glucose was assessed at weeks 1, 2, 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline plasma glucose as a covariate.
Timepoint [2] 0 0
Baseline and Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Secondary outcome [3] 0 0
Percentage of Participants With Marked Hyperglycemia - Marked Hyperglycemia is defined as fasting plasma glucose greater than or equal to 200 mg/dL. Study week windows are defined to place hyperglycemia into visit categories.
Timepoint [3] 0 0
Weeks 1, 2, 4, 8, 12, 16, 20 and 26.
Secondary outcome [4] 0 0
Percentage of Participants Meeting Rescue Criteria - Rescue was defined as meeting 1 of the following criteria, confirmed by a 2nd sample drawn within 5 days after the first sample and analyzed by the central laboratory:
After more than 4 weeks of treatment but prior to the Week 8 Visit: a single fasting plasma glucose =310 mg/dL (=17.5 mmol/L);
From the Week 8 Visit but prior to the Week 12 Visit: a single fasting plasma glucose =275 mg/dL (=15.27 mmol/L);
From the Week 12 Visit through the End-of-Treatment Visit: HbA1c =8.5% and =0.5% reduction in HbA1c as compared with the Baseline HbA1c.
Timepoint [4] 0 0
Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [5] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5% - Clinical response at Week 26 was assessed by the percentage of participants with HbA1c =6.5%.
Timepoint [5] 0 0
Week 26
Secondary outcome [6] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0% - Clinical response at Week 26 was assessed by the percentage of participants with HbA1c = 7%.
Timepoint [6] 0 0
Week 26
Secondary outcome [7] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.5% - Clinical response at Week 26 was assessed by the percentage of participants with HbA1c = 7.5%.
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 0.5% - Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 0.5%.
Timepoint [8] 0 0
Baseline and Week 26
Secondary outcome [9] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.0% - Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 1%.
Timepoint [9] 0 0
Baseline and Week 26
Secondary outcome [10] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 1.5%. - Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 1.5%.
Timepoint [10] 0 0
Baseline and Week 26
Secondary outcome [11] 0 0
Percentage of Participants With a Decrease in Glycosylated Hemoglobin Greater Than or Equal to 2.0% - Clinical response at Week 26 was assessed by the percentage of participants with a decrease from Baseline in HbA1c of = 2.0%.
Timepoint [11] 0 0
Baseline and Week 26
Secondary outcome [12] 0 0
Change From Baseline in Fasting Proinsulin - Proinsulin is a precursor to insulin, and was measured as an indicator of pancreatic function. The change from Baseline in fasting proinsulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline proinsulin as a covariate.
Timepoint [12] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [13] 0 0
Change From Baseline in Insulin - The change from Baseline in fasting insulin was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least Squares Means were from an ANCOVA model with treatment and geographic region as class variables and baseline insulin as a covariate.
Timepoint [13] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [14] 0 0
Change From Baseline in Proinsulin/Insulin Ratio - The ratio of proinsulin to insulin was calculated as proinsulin (pmol/L) / insulin (µIU/mL) at weeks 4, 8, 12, 16, 20 and 26 relative to the Baseline value. Least squares means were from an ANCOVA model with treatment and geographic region as class variables and Baseline proinsulin/insulin ratio as a covariate.
Timepoint [14] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [15] 0 0
Change From Baseline in C-peptide Levels - C-peptide is a byproduct created when the hormone insulin is produced and is measured by a blood test. Change from Baseline was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline C-peptide as a covariate.
Timepoint [15] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [16] 0 0
Change From Baseline in Calculated Homeostatic Model Assessment Insulin Resistance - The Homeostasis Model Assessment of insulin resistance (HOMA IR) measures insulin resistance based on fasting glucose and insulin measurements:
HOMA IR = fasting plasma insulin (µIU/mL) * fasting plasma glucose (mmol/L) / 22.5
A higher number indicates a greater degree of insulin resistance. The change from Baseline in HOMA IR was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA IR as a covariate.
Timepoint [16] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [17] 0 0
Change From Baseline in Homeostatic Model Assessment Beta Cell Function - The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function (%B) as a percentage of a normal reference population.
HOMA %B = 20 * insulin (µIU/mL) / fasting plasma glucose (mmol/L) - 3.5
The change from Baseline in the homeostasis model assessment of beta cell function was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HOMA beta cell function as a covariate.
Timepoint [17] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [18] 0 0
Change From Baseline in Body Weight - Change from Baseline in body weight was assessed at Weeks 8, 12, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline weight as a covariate.
Timepoint [18] 0 0
Baseline and Weeks 8, 12, 20 and 26.
Secondary outcome [19] 0 0
Change From Baseline in Total Cholesterol Level - Change from Baseline in total cholesterol level was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline total cholesterol as a covariate.
Timepoint [19] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [20] 0 0
Change From Baseline in Low-Density Lipoprotein Cholesterol - Change from Baseline in low-density lipoprotein cholesterol (LDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL cholesterol as a covariate.
Timepoint [20] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [21] 0 0
Change From Baseline in High-Density Lipoprotein Cholesterol - Change from Baseline in high-density lipoprotein cholesterol (HDL-C) was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL cholesterol as a covariate.
Timepoint [21] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [22] 0 0
Change From Baseline in Triglyceride Levels - Change from Baseline in triglycerides was assessed at Weeks 4, 8, 12, 16, 20 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline triglycerides as a covariate.
Timepoint [22] 0 0
Baseline and Weeks 4, 8, 12, 16, 20 and 26.
Secondary outcome [23] 0 0
Change From Baseline in Free Fatty Acids - Change from Baseline in free fatty acids (FFA) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline free fatty acid as a covariate.
Timepoint [23] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [24] 0 0
Change From Baseline in Plasminogen Activator Inhibitor-1 - Change from Baseline in plasminogen activator inhibitor-1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline plasminogen activator inhibitor-1 as a covariate.
Timepoint [24] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [25] 0 0
Change From Baseline in High-sensitivity C-Reactive Protein - Change from Baseline in high-sensitivity C-Reactive Protein (hsCRP) was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline hsCRP as a covariate.
Timepoint [25] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [26] 0 0
Change From Baseline in Adiponectin - Change from Baseline in adiponectin was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline adiponectin as a covariate.
Timepoint [26] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [27] 0 0
Change From Baseline in Apolipoprotein A1 - Change from Baseline in Apolipoprotein A1 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and Baseline apolipoprotein A1 as a covariate.
Timepoint [27] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [28] 0 0
Change From Baseline in Apolipoprotein A2 - Change from Baseline in apolipoprotein A2 was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein A2 as a covariate.
Timepoint [28] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [29] 0 0
Change From Baseline in Apolipoprotein B - Change from Baseline in apolipoprotein B was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein B as a covariate.
Timepoint [29] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [30] 0 0
Change From Baseline in Apolipoprotein C-III - Change from Baseline in apolipoprotein C-III was assessed at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline apolipoprotein C-III as a covariate.
Timepoint [30] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [31] 0 0
Change From Baseline in Nuclear Magnetic Resonance Lipid Fractionation Total Triglycerides - Nuclear Magnetic Resonance (NMR) lipid fractionation was used to assess the change from Baseline in total triglyceride levels at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline NMR total triglycerides as a covariate.
Timepoint [31] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [32] 0 0
Change From Baseline in Very Low Density Lipoprotein (VLDL) / Chylomicron Particles - The change from Baseline in levels of total VLDL/chylomicron particles and large VLDL/chylomicron particles was assessed by NMR lipid fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron particles as a covariate.
Timepoint [32] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [33] 0 0
Change From Baseline in VLDL / Chylomicron Triglycerides - The change from Baseline in levels of VLDL/chylomicron triglycerides was assessed by NMR lipid fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL/chylomicron triglycerides as a covariate.
Timepoint [33] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [34] 0 0
Change From Baseline in VLDL Particles - The change from Baseline in levels of medium VLDL particles and small VLDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline VLDL particles as a covariate.
Timepoint [34] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [35] 0 0
Change From Baseline in Mean VLDL Particle Size - Change from Baseline in mean VLDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean VLDL particle size as a covariate.
Timepoint [35] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [36] 0 0
Change From Baseline in Intermediate Density Lipoprotein (IDL) Particles - The change from Baseline in levels of IDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline IDL particles as a covariate.
Timepoint [36] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [37] 0 0
Change From Baseline in Low Density Lipoprotein (LDL) Particles - The change from Baseline in levels of total, large, medium-small, total small and very small LDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline LDL particles as a covariate.
Timepoint [37] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [38] 0 0
Change From Baseline in Mean LDL Particle Size - Change from Baseline in mean LDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean LDL particle size as a covariate.
Timepoint [38] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [39] 0 0
Change From Baseline in High Density Lipoprotein (HDL) Particles - The change from Baseline in levels of total, large, medium and small HDL particles was assessed by NMR fractionation at Weeks 12 and 26.
Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline HDL particles as a covariate.
Timepoint [39] 0 0
Baseline and Weeks 12 and 26.
Secondary outcome [40] 0 0
Change From Baseline in Mean HDL Particle Size - Change from Baseline in mean HDL particle size was assessed by NMR lipid fractionation at Weeks 12 and 26. Least squares means are from an ANCOVA model with treatment and geographic region as class variables and baseline mean HDL particle size as a covariate.
Timepoint [40] 0 0
Baseline and Weeks 12 and 26.

Eligibility
Key inclusion criteria
Inclusion Criteria

- Historical diagnosis of type 2 diabetes.

- Failed treatment with diet and exercise for at least 2 months prior to Screening.

- Is experiencing inadequate glycemic control as defined as glycosylated hemoglobin
concentration between 7.5-11%, inclusive.

- Has received any antidiabetic therapy for less than 7 days within 3 months prior to
Screening.

- Has a body mass index greater than or equal to 23 kg/m2 and less than or equal to45
kg/m2.

- Fasting C-peptide greater than or equal to 0.8 ng per mL.

- Regular use of other, non-excluded medications is allowed if participant is on a
stable dose for at least 4 weeks prior to Screening.

- Females of childbearing potential who are sexually active must agree to use adequate
contraception, and can neither be pregnant nor lactating from Screening throughout the
duration of the study.

- Must be willing and able to monitor their blood concentrations with a home glucose
monitor.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

- Systolic blood pressure greater than or equal to 160 mmHg and diastolic blood pressure
greater than or equal to 100 mmHg.

- Hemoglobin less than or equal to 12 g per dL for males and less than or equal to 10 g
per dL for females.

- Alanine aminotransferase greater than or equal to 2.5times the upper limit of normal.

- Serum creatinine greater than 2.0 mg per dL.

- Thyroid stimulating hormone level greater than the upper limit of normal range.

- Major illness or debility that in the investigator's opinion prohibits the subject
from completing the study.

- Urine albumin to creatinine ratio of greater than 1000 ug per mg at Screening. If
elevated, the subject may be rescreened within 1 week.

- History of cancer, other than squamous cell or basal cell carcinoma of the skin, that
has not been in full remission for at least 5 years prior to Screening

- History of laser treatment for proliferative diabetic retinopathy within 6 months
prior to Screening.

- History of gastroparesis.

- Has New York Heart Association Class I to IV heart failure regardless of therapy.

- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or
myocardial infarction within 6 months prior to Screening.

- History of any hemoglobinopathy that may affect determination of glycosylated
hemoglobin.

- History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.

- History of a psychiatric disorder that will affect participant's ability to
participate in the study.

- History of angioedema in association with use of angiotensin-converting enzyme
inhibitors or angiotensin-II receptor inhibitors.

- Any alteration in angiotensin-II receptor inhibitors within 2 months prior to
Randomization, if applicable.

- History of alcohol (defined as regular or daily consumption of more than 4 alcoholic
drinks per day) or substance abuse (defined as illicit drug use) within 2 years prior
to Screening.

- Received any investigational drug within 30 days prior to Screening or a history of
receipt of an investigational antidiabetic drug within 3 months prior to Screening.

- Previously participated in an investigational study of SYR-322.

- Glycosylated hemoglobin concentration between 7.5-11%, inclusive, and a fasting plasma
glucose less than 310 mg per dL.

- At least 75% compliant with the single-blind placebo regimen during the
run-in/stabilization period.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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)
NSW,VIC
Recruitment hospital [1] 0 0
- Kingswood
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
- Frankston
Recruitment postcode(s) [1] 0 0
- Kingswood
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- Frankston
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nevada
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Utah
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West Virginia
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Brazil
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CE
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Brazil
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GO
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Brazil
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PA
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Brazil
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PR
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Brazil
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RP
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Brazil
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SP
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Bulgaria
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Pleven
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Chile
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Santiago
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Croatia
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Pärnu
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Eger
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Gyula
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Mako
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India
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Hadera
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jaffa Tel Aviv
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Israel
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Jerusalem
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Israel
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Nahariya
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Latvia
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Riga
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Lithuania
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Kaunas
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Lithuania
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Kedainiai
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Mexico
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Aguascalientes
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Mexico
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Mexico City
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Mexico
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Monterrey
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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Bialystok
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Bytom
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Gdansk
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Gniewkowo
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Kamieniec Zabkowicki
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Krakow
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Leczyca
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Brasov
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State/province [76] 0 0
Bucharest
Country [77] 0 0
Romania
State/province [77] 0 0
Galati
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Ekaterinburg
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Kazan
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Moscow
Country [81] 0 0
Serbia
State/province [81] 0 0
Belgrade
Country [82] 0 0
Serbia
State/province [82] 0 0
Kragujevac
Country [83] 0 0
Serbia
State/province [83] 0 0
Nis
Country [84] 0 0
Slovakia
State/province [84] 0 0
Nitra
Country [85] 0 0
Slovakia
State/province [85] 0 0
Banska Bysterica
Country [86] 0 0
Slovakia
State/province [86] 0 0
Lucenec
Country [87] 0 0
Slovakia
State/province [87] 0 0
Riverside
Country [88] 0 0
Slovakia
State/province [88] 0 0
Sahy
Country [89] 0 0
South Africa
State/province [89] 0 0
Eastern Cape
Country [90] 0 0
South Africa
State/province [90] 0 0
Gauteng
Country [91] 0 0
South Africa
State/province [91] 0 0
Kwa-Zulu Natal
Country [92] 0 0
South Africa
State/province [92] 0 0
Pretoria
Country [93] 0 0
South Africa
State/province [93] 0 0
Western Province
Country [94] 0 0
Ukraine
State/province [94] 0 0
Dnipropetrovsk
Country [95] 0 0
Ukraine
State/province [95] 0 0
Kharkiv
Country [96] 0 0
Ukraine
State/province [96] 0 0
Lviv
Country [97] 0 0
Ukraine
State/province [97] 0 0
Odesa

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the combination of alogliptin, once daily (QD), and
pioglitazone in patients with type 2 diabetes mellitus who are inadequately controlled with
diet and exercise alone.
Trial website
https://clinicaltrials.gov/show/NCT00395512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
VP, Biological Sciences
Address 0 0
Takeda
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