None listed
Conditions
Interventions
Group 1 Type of group
400 mg of dutogliptin will be administered orally once a day, with or without food.
Group name:Group 2 Type of group
100 mg of sitagliptin will be administered orally once a day, with or without food.
Sponsors
PHENOMIX CORPORATION,
Eligibility
Age
18 Years to 85 Years
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.
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 |
|---|---|
| Outcome name:Through laboratory tests performed during the study. Measure:Changes in HbA1c and fasting blood glucose compared to baseline Timepoints:Visit 4 / Day 28 of the main study, PHX1149-PROT302) at each visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:as assessed by vital signs, adverse event reporting, routine clinical laboratory assessments, and ECG Measure:To demonstrate safety and tolerability of dutogliptin Timepoints:52 weeks | — |
Countries
Argentina, Czech Republic, India, Peru, Poland, United States
Contacts
Public ContactNicolas Emilio Sandoval
INC Research Peru S.A.C
Outcome results
None listed