NCT00970424TerminatedPhase 3
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone
Forest Laboratories118 sites in 1 country252 target enrollmentStarted: August 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 252
- Locations
- 118
- Primary Endpoint
- Hemoglobin A1c Level (HbA1c)
Study Overview
Brief Summary
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1)
- •BMI 20 to 48 kg/m2, inclusive
- •HbA1c 7.0% - 10.0%, inclusive
- •Age 18 to 85 years, inclusive
Exclusion Criteria
- •Currently taking more than one oral hypoglycemic agent
- •Type 1 diabetes mellitus
Arms & Interventions
1
Placebo Comparator
placebo, oral tablet administered once daily on background of pioglitazone
Intervention: Placebo (Drug)
2
Experimental
dutogliptin, oral tablet administered once daily on background of pioglitazone
Intervention: Dutogliptin (Drug)
Outcomes
Primary Outcomes
Hemoglobin A1c Level (HbA1c)
Time Frame: HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26)
Secondary Outcomes
- Fasting Plasma Glucose Level (FPG)(FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26).)
Investigators
Study Sites (118)
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