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Clinical Trials/NCT00970424
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:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Enrollment
252
Locations
118
Primary Endpoint
Hemoglobin A1c Level (HbA1c)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

Sponsor
Forest Laboratories
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (118)

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