Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

Phase 3

Terminated

• Conditions: Diabetes Mellitus, Type II
• Interventions: Drug: Placebo; Drug: Dutogliptin

• Registration Number: NCT00970424
• Lead Sponsor: Forest Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2010-08
• Status Verified: 2011-09
• Disposition First Submitted: 2011-09-09
• Disposition First Submitted QC: 2011-09-09
• Last Update Submitted: 2011-09-09
• Disposition First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	placebo, oral tablet administered once daily on background of pioglitazone
2	Dutogliptin	dutogliptin, oral tablet administered once daily on background of pioglitazone

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c Level (HbA1c)	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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (118)

Forest Investigative Site 064; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 020; 🇺🇸 Birmingham, Alabama, United States

Forest Investigative Site 059; 🇺🇸 Chandler, Arizona, United States

Forest Investigative Site 096; 🇺🇸 Litchfield, Arizona, United States

Forest Investigative Site 098; 🇺🇸 Phoenix, Arizona, United States

Forest Investigative Site 044; 🇺🇸 Scottsdale, Arizona, United States

Forest Investigative Site 087; 🇺🇸 Tucson, Arizona, United States

Forest Investigative Site 061; 🇺🇸 Anaheim, California, United States

Forest Investigative Site 041; 🇺🇸 Chula Vista, California, United States

Forest Investigative Site 049; 🇺🇸 Encinitas, California, United States

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