Skip to main content
OpenTrials
Completed

NCT Number: NCT01318109

Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan

The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

26 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

The present study was planned to evaluate the efficacy and safety of alogliptin as an add-on to metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin as well as diet and exercise therapies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
  • Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
  • Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
  • Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion criteria

  • Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
  • With a history or symptoms of lactic acidosis.

Treatment and study plan

Alogliptin and Metformin

Drug

Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.

Other names: SYR-32, Glycoran

metformin

Drug

Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Other names: Glycoran

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (Week 12).

    Time frame: Baseline and Week 12.

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.

Secondary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (Week 2).

    Time frame: Baseline and Week 2.

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 2 and glycosylated hemoglobin collected at baseline.

  2. Change From Baseline in Glycosylated Hemoglobin (Week 4).

    Time frame: Baseline and Week 4.

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 4 and glycosylated hemoglobin collected at baseline.

  3. Change From Baseline in Glycosylated Hemoglobin (Week 8).

    Time frame: Baseline and Week 8.

    The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 8 and glycosylated hemoglobin collected at baseline.

  4. Change From Baseline in Fasting Plasma Glucose (Week 2).

    Time frame: Baseline and Week 2.

    The change between the value of fasting plasma glucose collected at week 2 and baseline.

  5. Change From Baseline in Fasting Plasma Glucose (Week 4).

    Time frame: Baseline and Week 4.

    The change between the value of fasting plasma glucose collected at week 4 and baseline.

  6. Change From Baseline in Fasting Plasma Glucose (Week 8).

    Time frame: Baseline and Week 8.

    The change between the value of fasting plasma glucose collected at week 8 and baseline.

  7. Change From Baseline in Fasting Plasma Glucose (Week 12).

    Time frame: Baseline and Week 12.

    The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.

  8. Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).

    Time frame: Baseline and Week 12.

    The change between the value of blood glucose measured by the meal tolerance test collected at week 12 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Metformin in Subjects With Type 2 Diabetes in Japan

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 18, 2011
Registry last updated
Feb 3, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.