Safety and Efficacy Study of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformin

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: placebo; Drug: dutogliptin

• Registration Number: NCT00850239
• Lead Sponsor: Phenomix

Brief Summary

The purpose of this study is to demonstrate the efficacy of dutogliptin over 26 weeks (as evidenced by placebo-corrected changes in HbA1c relative to baseline), to demonstrate safety and tolerability of dutogliptin, and to demonstrate changes in fasting plasma glucose over 26 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-24
• Study Start: 2009-05
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11
• Primary Completion: 2010-10
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Type 2 diabetes mellitus, diagnosed at least 4 months prior to Screening (Visit 1)
• Age 18 to 85 years, inclusive.
• Male and non-pregnant, non-lactating (and not planning to become pregnant during the study) female subjects with a BMI of 20 to 48 kg/m2, inclusive
• Current treatment of Type 2 diabetes mellitus with a stable dose of metformin of ≥ 2000 mg (or the highest tolerated dose) used in accordance with product labeling for at least 6 weeks prior to screening (Visit 1)
• HbA1c 7.0% - 10.0%, inclusive; and fasting plasma C peptide greater than 0.26 nmol/L (> 0.8 ng/mL; > 281 pmol/L) at screening (Visit 1)

Exclusion Criteria

• Type 1 diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	placebo	Plabeco
1	dutogliptin	dutogliptin/PHX1149T

Primary Outcome Measures

Name	Time	Method
Primary objective is to demonstrate the efficacy of dutogliptin, as evidenced by placebo-corrected changes in HbA1c relative to baseline.	26 weeks

Secondary Outcome Measures

Name	Time	Method
Demonstrate safety and tolerability of dutogliptin	26 weeks
• Demonstrate changes in fasting plasma glucose	26 weeks

Trial Locations

Locations (97)

Phenomix Investigational Site 115; 🇺🇸 Montgomery, Alabama, United States

Phenomix Investigational Site 121; 🇺🇸 Tempe, Arizona, United States

Phenomix Investigational Site 137; 🇺🇸 Tempe, Arizona, United States

Phenomix Investigational Site 105; 🇺🇸 Anaheim, California, United States

Phenomix Investigational Site 123; 🇺🇸 Chico, California, United States

Phenomix Investigational Site 134; 🇺🇸 Escondido, California, United States

Phenomix Investigational Site 103; 🇺🇸 Long Beach, California, United States

Phenomix Investigational Site 106; 🇺🇸 Los Angeles, California, United States

Phenomix Investigational Site 143; 🇺🇸 Coral Gables, Florida, United States

Phenomix Investigational Site 142; 🇺🇸 Hialeah, Florida, United States

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