Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: PHX1149T

• Registration Number: NCT00690638
• Lead Sponsor: Phenomix

Brief Summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Study Start: 2008-07
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-04
• Last Update Submitted: 2010-04-12
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

• Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
• BMI 25 to 48 kg/m2, inclusive
• HbA1c 7.0% - 10.0%, inclusive
• Age 18 to 75 years, inclusive

Exclusion Criteria

• Currently on 3 or more oral antidiabetic drugs or insulin.
• Type 1 diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	PHX1149T	PHX1149T 200 mg
3	PHX1149T	PHX1149T 400 mg

Primary Outcome Measures

Name	Time	Method
To demonstrate changes in HbA1c	Day 28 to Day 196