- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263483
Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
|
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:
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
|
Experimental: Alogliptin 25 mg QD and Voglibose 0.2 mg TID
|
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:
Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
|
Active Comparator: Voglibose 0.2 mg TID
|
Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Week 12.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and Week 8.
|
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.
|
Baseline and Week 8.
|
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.
|
Baseline and Week 8.
|
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.
|
Baseline and Week 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.
|
Baseline and Week 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.
|
Baseline and Week 2
|
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.
|
Baseline and Week 4.
|
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.
|
Baseline and Week 12.
|
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.
|
Baseline and Week 2.
|
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.
|
Baseline and Week 4.
|
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.
|
Baseline and Week 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.
|
Baseline and Week 12.
|
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.
|
Baseline and Week 12.
|
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.
|
Baseline and Week 12
|
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.
|
Baseline and Week 12.
|
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.
|
Baseline and Week 12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Professor, Department of Medicine, Kawasaki Medical School
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Micronutrients
- Vitamins
- Incretins
- Vitamin B Complex
- Dipeptidyl-Peptidase IV Inhibitors
- Glycoside Hydrolase Inhibitors
- Inositol
- Alogliptin
- Voglibose
Other Study ID Numbers
- SYR-322/CCT-003
- U1111-1118-3955 (Registry Identifier: WHO)
- JapicCTI-080589 (Registry Identifier: JapicCTI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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