A Phase 3, Randomized, Double-Blind, Active-Controlled, Multi-Center Extension Study to Evaluate Safety and Efficacy of Dutogliptin in Subjects With Type 2 Diabetes Mellitus on a Background Medication of Metformi
- Conditions
- Type 2 diabetes mellitusMedDRA version: 12.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus
- Registration Number
- EUCTR2009-012663-34-CZ
- Lead Sponsor
- Phenomix Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate safety and tolerability of dutogliptin;Secondary Objective: To demonstrate maintenance or lowering of HbA1c and fasting<br>plasma glucose;Primary end point(s): The primary variable is safety from Visit 8/Day 210 to Visit 13/Day 574.
- Secondary Outcome Measures
Name Time Method