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Completed

NCT Number: NCT01263483

Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor 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 an α-glucosidase inhibitor taken three times daily (TID) 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–85 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.

In Japan, α-glucosidase inhibitors are widely used as a first-line treatment for type 2 diabetes mellitus. Because alogliptin has a different mechanism of action compared to α-glucosidase inhibitors, the study evaluated the efficacy and safety of alogliptin combined with an α-glucosidase inhibitor in type 2 diabetic patients with uncontrolled blood glucose while taking a α-glucosidase inhibitor and receiving diet and/or exercise therapies.

To evaluate the long-term safety and efficacy of the concomitant use of alogliptin and an α-glucosidase inhibitor, subjects who participated in the present study could enter a long-term extension study SYR-322/OCT-003 (NCT01263509) that was planned separately.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Had been receiving a stable dose and regimen of an α-glucosidase inhibitor for the last 4 weeks or longer before the start of the screening phase (Week -8) and during the screening phase.
  • Had a glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of the screening phase (Week -4).
  • Had HbA1c differences within 10.0% at the start of the screening phase (Week -8) and 4 weeks after the start of the screening phase (Week -4) from the HbA1c value at the start of the screening phase.
  • Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of the screening phase (Week -8).

Exclusion criteria

  • Had received any antidiabetic drug other than α-glucosidase inhibitors within the last 4 weeks before the start of the screening phase (Week -8) or during the screening phase.

Treatment and study plan

Alogliptin and voglibose

Drug

Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.

Other names: SYR-322, BASEN®, Voglibose

Voglibose

Drug

Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.

Other names: BASEN®

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 fasting plasma glucose 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 fasting plasma glucose 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 fasting plasma glucose 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 fasting plasma glucose collected at baseline.

  8. Change From Baseline in Fasting C-peptide (Week 2).

    Time frame: Baseline and Week 2.

    The change between the value of fasting C-peptide collected at week 2 and fasting C-peptide collected at baseline.

  9. Change From Baseline in Fasting C-peptide (Week 4).

    Time frame: Baseline and Week 4.

    The change between the value of fasting C-peptide collected at week 4 and fasting C-peptide collected at baseline.

  10. Change From Baseline in Fasting C-peptide (Week 8).

    Time frame: Baseline and Week 8.

    The change between the value of fasting C-peptide collected at week 8 and fasting C-peptide collected at baseline.

  11. Change From Baseline in Fasting C-peptide (Week 12).

    Time frame: Baseline and Week 12.

    The change between the value of fasting C-peptide collected at week 12 or final visit and fasting C-peptide collected at baseline.

  12. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (2-hr Postprandial Value).

    Time frame: Baseline and Week 12.

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

  13. Change From Baseline in Blood Glucose Measured by Meal Tolerance Testing (AUC (0-2)).

    Time frame: Baseline and Week 12.

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

  14. Change From Baseline in Insulin Measured by Meal Tolerance Testing (AUC(0-2).

    Time frame: Baseline and Week 12

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

  15. Change From Baseline in C-peptide Measured by Meal Tolerance Testing (AUC(0-2).

    Time frame: Baseline and Week 12.

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

  16. Change From Baseline in Glucagon Measured by Meal Tolerance Testing (AUC (0-2)).

    Time frame: Baseline and Week 12

    The change between the value of glucagons collected at week 12 or final visit and glucagons collected at baseline. Meal tolerance test measures blood glucose, insulin, C-peptide and glucagon 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 α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 20, 2010
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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