A clinical trial to study the long-term safety of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on aBackground Medication of Metformin

Phase 3

• Conditions: Health Condition 1: null- Type 2 Diabetes Mellitus

• Registration Number: CTRI/2010/091/000500
• Lead Sponsor: Phenomix Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other
• Sex: Not specified
• Target Recruitment: 650

Inclusion Criteria

1. Completion of all required visits of the placebo-controlled Phase 3 core protocol PHX1149-PROT302 (e.g., Visit 8/Day 210). Subjects who received rescue therapy but completed the core protocol will be eligible.

2. Current treatment of Type 2 diabetes mellitus as set forth in the prior placebo controlled Phase 3 core protocol PHX1149-PROT302. Subjects will initially be on a background of metformin only, or metformin and pioglitizone if previously rescued in the core protocol.

3. For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to study enrollment); IUD; Depo-Provera®; Norplant® System implants; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam, or jelly; and abstinence.

4. Willingness to return for all clinic visits and complete all study-related procedures, including self-monitoring of blood glucose up to 5 times per week.

5. Ability to understand and provide informed consent

Exclusion Criteria

1. Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient?s appropriate participation in this study or obscure the effects of treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary variable is safety from Visit 8/Day 210 to Visit 13/Day 574Timepoint: Not Applicable

Secondary Outcome Measures

Name	Time	Method
Secondary efficacy endpoints include: <br/ ><br>1. Change in HbA1c from Visit 4/Day 28 to Visit 13/Day 574. <br/ ><br>2. Change in fasting plasma glucose from Visit 4/Day 28 to Visit 13/Day 574. <br/ ><br>Timepoint: Not Applicable