- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318070
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine 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 Thiazolidine 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.
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.
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 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.
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 Pioglitazone 15 or 30mg QD
|
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Names:
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Names:
|
Experimental: Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD
|
Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Names:
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
Other Names:
|
Active Comparator: Pioglitazone (15mg or 30mg ) QD
|
Pioglitazone 15 or 30 mg, tablets orally once daily for up 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 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 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 glycosylated hemoglobin 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 glycosylated hemoglobin collected at baseline.
|
Baseline and Week 4.
|
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.
|
Baseline and Week 8.
|
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.
|
Baseline and Week 12.
|
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.
|
Baseline and Week 12.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Professor, Diabetes and Endocrine Division, Department of Medicine, Kawasaki Medical School
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
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Pioglitazone
- Alogliptin
Other Study ID Numbers
- SYR-322/CCT-004
- UMIN000001382 (Registry Identifier: UMIN-CTR)
- JapicCTI-080590 (Registry Identifier: JapicCTI)
- U1111-1118-4073 (Registry Identifier: WHO)
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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