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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00856284




Registration number
NCT00856284
Ethics application status
Date submitted
4/03/2009
Date registered
4/03/2009
Date last updated
25/09/2013

Titles & IDs
Public title
Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
Scientific title
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
2008-007444-34
Secondary ID [2] 0 0
SYR-322_305
Universal Trial Number (UTN)
Trial acronym
ENDURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 0 0
Type 2 Diabetes Mellitus 0 0
Type 2 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 - Metformin
Treatment: Drugs - Glipizide
Treatment: Drugs - Alogliptin
Treatment: Drugs - Metformin
Treatment: Drugs - Glipizide
Treatment: Drugs - Alogliptin
Treatment: Drugs - Metformin
Treatment: Drugs - Glipizide

Experimental: Metformin + Alogliptin 12.5 mg - Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.

Experimental: Metformin + Alogliptin 25 mg - Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.

Active Comparator: Metformin + Glipizide - Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose =250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.

Experimental: Metformin + Alogliptin 12.5 mg - Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.

Experimental: Metformin + Alogliptin 25 mg - Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.

Active Comparator: Metformin + Glipizide - Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose =250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.

Experimental: Metformin + Alogliptin 12.5 mg - Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.

Experimental: Metformin + Alogliptin 25 mg - Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.

Active Comparator: Metformin + Glipizide - Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose =250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.


Treatment: Drugs: Alogliptin
Alogliptin tablets

Treatment: Drugs: Metformin
Metformin tablets

Treatment: Drugs: Glipizide
Glipizide tablets

Treatment: Drugs: Alogliptin
Alogliptin tablets

Treatment: Drugs: Metformin
Metformin tablets

Treatment: Drugs: Glipizide
Glipizide tablets

Treatment: Drugs: Alogliptin
Alogliptin tablets

Treatment: Drugs: Metformin
Metformin tablets

Treatment: Drugs: Glipizide
Glipizide tablets

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

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 - The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [1] 0 0
Baseline and Week 52
Primary outcome [2] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 - The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [2] 0 0
Baseline and Week 104
Primary outcome [3] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 - The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [3] 0 0
Baseline and Week 52
Primary outcome [4] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 - The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [4] 0 0
Baseline and Week 104
Primary outcome [5] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52 - The change from Baseline to Week 52 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [5] 0 0
Baseline and Week 52
Primary outcome [6] 0 0
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 104 - The change from Baseline to Week 104 in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). The least squares (LS) means are from an analysis of covariance (ANCOVA) model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [6] 0 0
Baseline and Week 104
Secondary outcome [1] 0 0
Change From Baseline in Glycosylated Hemoglobin at Other Time Points - The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [1] 0 0
Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.
Secondary outcome [2] 0 0
Change From Baseline in Fasting Plasma Glucose Over Time - The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.
Timepoint [2] 0 0
Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.
Secondary outcome [3] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5% - The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
Timepoint [3] 0 0
Weeks 26, 52, 78, and 104.
Secondary outcome [4] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0% - Percentage of participants with HbA1c = 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
Timepoint [4] 0 0
Weeks 26, 52, 78, and 104.
Secondary outcome [5] 0 0
Change From Baseline in Body Weight Over Time - LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.
Timepoint [5] 0 0
Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.
Secondary outcome [6] 0 0
Change From Baseline in Glycosylated Hemoglobin at Other Time Points - The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [6] 0 0
Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.
Secondary outcome [7] 0 0
Change From Baseline in Fasting Plasma Glucose Over Time - The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.
Timepoint [7] 0 0
Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.
Secondary outcome [8] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5% - The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
Timepoint [8] 0 0
Weeks 26, 52, 78, and 104.
Secondary outcome [9] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0% - Percentage of participants with HbA1c = 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
Timepoint [9] 0 0
Weeks 26, 52, 78, and 104.
Secondary outcome [10] 0 0
Change From Baseline in Body Weight Over Time - LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.
Timepoint [10] 0 0
Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.
Secondary outcome [11] 0 0
Change From Baseline in Glycosylated Hemoglobin at Other Time Points - The change from Baseline over time in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound). LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline metformin dose and Baseline HbA1c as covariates.
Timepoint [11] 0 0
Baseline and Weeks 4, 8, 12, 16, 20, 26, 39, 65, 78, and 91.
Secondary outcome [12] 0 0
Change From Baseline in Fasting Plasma Glucose Over Time - The change from Baseline in fasting plasma glucose (FPG) was assessed at Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104. LS means are from an ANCOVA model with treatment, study schedule, and geographic region as class variables, and Baseline FPG and Baseline metformin dose as covariates.
Timepoint [12] 0 0
Baseline and Weeks 2, 4, 8, 12, 16, 20, 26, 39, 52, 65, 78, 91, and 104.
Secondary outcome [13] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 6.5% - The percentage of participants with HbA1c less than or equal to 6.5% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
Timepoint [13] 0 0
Weeks 26, 52, 78, and 104.
Secondary outcome [14] 0 0
Percentage of Participants With Glycosylated Hemoglobin Less Than or Equal to 7.0% - Percentage of participants with HbA1c = 7.0% at Weeks 26, 52, 78, and 104. Participants who did not complete the scheduled Week 104 visit were assessed based on their response at the time of discontinuation.
Timepoint [14] 0 0
Weeks 26, 52, 78, and 104.
Secondary outcome [15] 0 0
Change From Baseline in Body Weight Over Time - LS Means are from an ANCOVA model with treatment, study schedule and geographic region as class variables, and Baseline weight and Baseline metformin dose as covariates.
Timepoint [15] 0 0
Baseline and Weeks 12, 26, 39, 52, 65, 78, 91, and 104.

Eligibility
Key inclusion criteria
- Has a diagnosis of type 2 diabetes mellitus.

- Must meet one of the following:

- Has been inadequately controlled on a stable daily dose of =1500 mg (or
documented maximum tolerated dose) of metformin for at least 2 months prior to
Screening.

- Has been inadequately controlled (as defined by a glycosylated hemoglobin 7.5 -
10%, inclusive) on metformin <1500 mg without documented maximum tolerated dose.

- No treatment with antidiabetic agents other than metformin within 2 months prior to
Screening (for Schedule A)/Pre-Screening (for Schedule B).

- Has body mass index within 23 kg/m^2 and 45 kg/m^2 unless the patient is Asian or of
Asian descent, for whom the allowable body mass index will be = 20 kg/m^2 and = 35
kg/m^2, inclusive.

- Has fasting C-peptide concentration at least 0.8 ng.

- If regularly using non-excluded medications, must be on a stable dose at least 4 weeks
prior to Screening/Pre-screening.

- Females of childbearing potential who are sexually active must agree to use adequate
contraception, and can neither be pregnant, lactating or intends to donate ova from
Screening throughout the duration of the study.

- Must be able and willing to monitor their blood glucose concentrations with a home
monitor, and comply with protocol requirements including scheduled clinic
appointments.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Systolic blood pressure greater than or equal to 150 mmHg and/or diastolic pressure
greater than or equal to 90.

- Hemoglobin less than or equal to 12 g/dL for males and less than or equal to 10 g/dL
for females at Screening Visit.

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

- Serum creatinine greater than or equal to 1.5 mg/dL for males and 1.4 for females, or
calculated creatinine clearance less than 60 L/min.

- Males intending to impregnate others or donate sperm before, during or within 1 month
after participating in the study.

- A history of cancer other than squamous or basal cell carcinoma of the skin that has
not been in full remission for at least 5 years.

- A history of laser treatment for diabetic retinopathy within 6 months of screening.

- Treated for diabetic gastric paresis, gastric banding, or gastric bypass.

- New York Heart Association Class III or IV heart failure.

- History of coronary angioplasty, coronary stent placement, coronary bypass surgery,
myocardial infarction, stroke or transient ischemic attack within 3 months prior to
screening.

- Known history of human immunodeficiency virus, hepatitis B or C.

- Alcohol or substance abuse within 2 years prior to screening.

- Is required to take or intends to continue taking any disallowed medication, any
prescription medication, herbal treatment or over-the counter medication that may
interfere with evaluation of the study medication, including:

- Any investigational drug within 30 days

- Any investigational diabetic drug within 3 months

- Any antidiabetic drug in the dipeptidyl peptidase-4 inhibitors or glucagon-like
peptide-1 mimetics classes within 90 days prior to Screening other than metformin

- Prior treatment with alogliptin.

- Weight-loss drugs

- Oral or systemically injected glucocorticoids

- A hypersensitivity allergy or anaphylactic reaction to any dipeptidyl peptidase-4
drug, metformin or glipizide.

- Has a documented history or concurrent signs of significant thyroid disease (eg,
autoimmune thyroid diseases such as Graves disease and Hashimoto thyroiditis or active
thyroid nodules).

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 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)
ACT,NSW,QLD,WA
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Wollongong
Recruitment hospital [3] 0 0
- Herston
Recruitment hospital [4] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Wollongong
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
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Florida
Country [7] 0 0
United States of America
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Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
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Kentucky
Country [11] 0 0
United States of America
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Louisiana
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United States of America
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Maine
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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United States of America
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Virginia
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Argentina
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Mar del Plata
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Austria
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Graz
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Austria
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Salzburg
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Brazil
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Pernambuco
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Brazil
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Planalto Central
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Brazil
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São Paulo
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Brazil
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Fortaleza
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Germany
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Brandenburg
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Germany
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Hesse
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Germany
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North Rhine-Westphalia
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Germany
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Rhineland-Palatinate
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Guatemala
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Hong Kong
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Kowloon
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Hong Kong
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Southern District
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Baranya
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Hungary
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Borsod-Abaúj-Zemplén
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Hungary
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Bács-Kiskun
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Hungary
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Békés
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Csongrád
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Hungary
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Szabolcs-Szatmár-Bereg
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Hungary
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Zala
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Hungary
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Budapest
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India
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Andhra Pradesh
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India
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Bihar
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India
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Haryana
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India
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Karnataka
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Madhya Pradesh
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India
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Maharashtra
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India
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Tamil Nadu
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Israel
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Center District
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Israel
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Central District
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Israel
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Haifa District
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Israel
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Northern District
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Israel
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Southern District
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Israel
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Tel Aviv
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Israel
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Jerusalem
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Israel
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Zefat
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Italy
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Milan
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Italy
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Perugia
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Italy
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Pistoia
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Korea, Republic of
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Honam
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Korea, Republic of
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Hoseo
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Korea, Republic of
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Yeongnam
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Latvia
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Liepaja
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Latvia
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Limbazi
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Latvia
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Ogre
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Latvia
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Riga
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Latvia
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Talsi
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Latvia
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Tukums
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Latvia
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Valmiera
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Lithuania
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Alytus
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Lithuania
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Kaunas
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Lithuania
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Kedainiai
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Lithuania
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Klaipeda
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Lithuania
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Palanga
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Lithuania
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Panevezys
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Lithuania
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Vilnius
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Malaysia
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Ipoh
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Malaysia
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Kajang
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Malaysia
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Kota Bahru
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Malaysia
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Kota Bharu
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Malaysia
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Kuala Terengganu
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Malaysia
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Kuantan
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Malaysia
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Melaka
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Malaysia
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Taiping
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Mexico
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Distrito Federal
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Mexico
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Edo de Mexico
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Mexico
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Huixquilucan Edo. de Mexico
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Mexico
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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 determine the safety and effectiveness of adding alogliptin,
once daily (QD), compared to glipizide with metformin in diabetic patients.
Trial website
https://clinicaltrials.gov/show/NCT00856284
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director, Clinical Science
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