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Completed

NCT Number: NCT01289119

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, Beijing Municipality, China

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About this study

Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality.

Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.

Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.

  • Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
  • Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
  • Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has a historical diagnosis of Type 2 Diabetes Mellitus.
  • Has a body mass index between acceptable range.
  • Is experiencing inadequate glycemic control.
  • Body weight keeps constant.
  • Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.

Exclusion criteria

  • Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
  • Has a systolic blood pressure beyond the acceptable range at Screening visit.
  • Has New York Heart Association Class III or IV heart failure regardless of therapy.
  • Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
  • Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.

Treatment and study plan

Alogliptin

Drug

Alogliptin tablets

Other names: SYR-322

Placebo to alogliptin

Drug

Alogliptin placebo-matching tablets.

metformin

Drug

Stable metformin dose

Other names: Fortamet, Glucophage, Glumetza

pioglitazone

Drug

Stable pioglitazone dose

Other names: Actos

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline and Week 16.

    The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

Secondary outcomes

  1. Change From Baseline in HbA1c Over Time

    Time frame: Baseline and Weeks 4, 8 and 12.

    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 Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

  2. Change From Baseline in Fasting Plasma Glucose Over Time

    Time frame: Baseline and Weeks 4, 8, 12 and 16.

    The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

  3. Percentage of Participants With Marked Hyperglycemia

    Time frame: Randomization to Week 16.

    Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).

  4. Change From Baseline in Body Weight

    Time frame: Baseline and Weeks 8 and 16.

    The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.

  5. Percentage of Participants With HbA1c ≤6.5% at Week 16

    Time frame: Week 16

    Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.

  6. Percentage of Participants With HbA1c ≤7.0% at Week 16

    Time frame: Week 16

    Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.

  7. Percentage of Participants With HbA1c ≤7.5% at Week 16

    Time frame: Week 16

    Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.

  8. Percentage of Participants With a Decrease in HbA1c ≥ 0.5%

    Time frame: Baseline and Week 16

    Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.

  9. Percentage of Participants With a Decrease in HbA1c ≥1.0%

    Time frame: Baseline and Week 16

    Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.

  10. Percentage of Participants With a Decrease in HbA1c ≥1.5%

    Time frame: Baseline and Week 16.

    Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.

  11. Percentage of Participants With a Decrease in HbA1c ≥2.0%

    Time frame: Baseline and Week 16.

    Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 3, 2011
Registry last updated
Mar 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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