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Completed

NCT Number: NCT01318070

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

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

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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

33 year–88 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 pioglitazone in type 2 diabetic patients with uncontrolled blood glucose despite treatment with pioglitazone 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 pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
  • Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
  • Had HbA1c difference within 10.0%* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (*rounded off to the first decimal place).
  • Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion criteria

  • Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
  • Had a history or symptoms of cardiac failure.

Treatment and study plan

Alogliptin and pioglitazone

Drug

Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

Other names: Alogliptin (SYR-322), Pioglitazone: Actos®

pioglitazone

Drug

Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

Other names: Pioglitazone: Actos®

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 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 glycosylated hemoglobin collected at 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 glycosylated hemoglobin collected at 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 glycosylated hemoglobin collected at 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 glycosylated hemoglobin collected at 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 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 Thiazolidine in Subjects With Type 2 Diabetes in Japan

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
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.

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