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

Overview[ - collapse ][ - ]

Purpose The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.
ConditionType 2 Diabetes Mellitus
InterventionDrug: Alogliptin and metformin
Drug: Alogliptin and metformin
Drug: Metformin
PhasePhase 2/Phase 3
SponsorTakeda
Responsible PartyTakeda
ClinicalTrials.gov IdentifierNCT01318109
First ReceivedMarch 16, 2011
Last UpdatedFebruary 1, 2012
Last verifiedFebruary 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 16, 2011
Last Updated DateFebruary 1, 2012
Start DateAugust 2008
Estimated Primary Completion DateApril 2009
Current Primary Outcome MeasuresChange From Baseline in Glycosylated Hemoglobin (Week 12). [Time Frame: Baseline and Week 12.] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Change From Baseline in Glycosylated Hemoglobin (Week 2). [Time Frame: Baseline and Week 2.] [Designated as safety issue: No]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.
  • Change From Baseline in Glycosylated Hemoglobin (Week 4). [Time Frame: Baseline and Week 4.] [Designated as safety issue: No]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.
  • Change From Baseline in Glycosylated Hemoglobin (Week 8). [Time Frame: Baseline and Week 8.] [Designated as safety issue: No]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.
  • Change From Baseline in Fasting Plasma Glucose (Week 2). [Time Frame: Baseline and Week 2.] [Designated as safety issue: No]The change between the value of fasting plasma glucose collected at week 2 and baseline.
  • Change From Baseline in Fasting Plasma Glucose (Week 4). [Time Frame: Baseline and Week 4.] [Designated as safety issue: No]The change between the value of fasting plasma glucose collected at week 4 and baseline.
  • Change From Baseline in Fasting Plasma Glucose (Week 8). [Time Frame: Baseline and Week 8.] [Designated as safety issue: No]The change between the value of fasting plasma glucose collected at week 8 and baseline.
  • Change From Baseline in Fasting Plasma Glucose (Week 12). [Time Frame: Baseline and Week 12.] [Designated as safety issue: No]The change between the value of fasting plasma glucose collected at week 12 or final visit and baseline.
  • Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12). [Time Frame: Baseline and Week 12.] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief TitleEfficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
Official TitleA 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
Brief Summary
The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy
(QD) combined with metformin taken twice daily (BID) or three times daily (TID) in type 2
diabetic patients with uncontrolled blood glucose.
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 TypeInterventional
Study PhasePhase 2/Phase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes Mellitus
InterventionDrug: Alogliptin and metformin
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:
  • SYR-32
  • Glycoran
Drug: Alogliptin and metformin
Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
Other Names:
  • SYR-322
  • Glycoran
Drug: Metformin
Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
Other Names:
Glycoran
Study Arm (s)
  • Active Comparator: Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID
  • Active Comparator: Alogliptin 25mg QD and metformin 500mg BID or 750mg TID
  • Active Comparator: Metformin 500mg BID or 750mg TID

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment288
Estimated Completion DateApril 2009
Estimated Primary Completion DateApril 2009
Eligibility Criteria
Inclusion Criteria:

1. 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).

2. 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).

3. 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).

4. Was receiving specific diet and exercise (if any) therapies during the observation
period.

Exclusion Criteria:

1. Had taken other diabetic medications than metformin within 12 weeks before the
initiation of the treatment period (Week 0).

2. With a history or symptoms of lactic acidosis.
GenderBoth
Ages26 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01318109
Other Study ID NumbersSYR-322/CCT-006
Has Data Monitoring CommitteeNo
Information Provided ByTakeda
Study SponsorTakeda
CollaboratorsNot Provided
Investigators Study Director: Professor, Diabetes and Endocrine Division Department of Medicine, Kawasaki Medical School
Verification DateFebruary 2012