- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318109
Efficacy and Safety of Alogliptin Used Combination With Metformin 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 Metformin 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 metformin in type 2 diabetic patients who have uncontrolled blood glucose despite treatment with metformin 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 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.
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 |
---|---|
Active Comparator: Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID
|
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:
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Other Names:
|
Active Comparator: Alogliptin 25mg QD and metformin 500mg BID or 750mg TID
|
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:
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Other Names:
|
Active Comparator: Metformin 500mg BID or 750mg TID
|
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching 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 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 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 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 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 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 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 at 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
- Metformin
- Alogliptin
Other Study ID Numbers
- SYR-322/CCT-006
- JapicCTI-080629 (Registry Identifier: JapicCTI)
- UMIN000001394 (Registry Identifier: UMIN-CTR)
- U1111-1119-6303 (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.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
HighTide Biopharma Pty LtdRecruitingT2DM (Type 2 Diabetes Mellitus)China
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
Clinical Trials on Alogliptin and metformin
-
TakedaCompletedDiabetes MellitusChina, Taiwan, Korea, Republic of, Malaysia
-
TakedaCompletedDiabetes MellitusUnited States, Australia, Brazil, Chile, Guatemala, India, Mexico, New Zealand, Peru, South Africa, Czech Republic, Germany, Hungary, Netherlands, Poland, United Kingdom, Argentina
-
TakedaTerminatedDiabetes Mellitus, Type 2China, Hong Kong
-
TakedaCompleted
-
Fourth People's Hospital of ShenyangCompleted
-
University of CatanzaroUnknown
-
CelltrionCompleted
-
CelltrionCompleted
-
TakedaCompletedDiabetes Mellitus, Type 2United States, Ukraine, Israel, Mexico, Romania, Russian Federation, South Africa, Czech Republic, Puerto Rico, Poland, Hungary, Lithuania, Slovakia