Type 2 diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: dutogliptin
Product Code: PHX1149 Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: dutogliptin
Current Sponsor code: PHX1149 Tablets
Concentration unit: mg milligram(s)
Concentra
Sponsors
Phenomix Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate safety and tolerability of dutogliptin;Secondary Objective: To demonstrate maintenance or lowering of HbA1c and fasting plasma glucose;Primary end point(s): The primary variable is safety from Visit 8/Day 210 to Visit 13/Day 574. | — |
Countries
Czech Republic
Outcome results
None listed