Conditions: Type 2 Diabetes Mellitus
Keywords: GLP-1, incretin, type 2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with CJC-1134-PC in patients who are currently on metformin monotherapy.

Detailed description:

Arms:
arm 1: Twice-a-week dose of 1.5 mg CJC-1134-PC arm 2: Twice-a-week dose of 1.5 mg CJC-1134-PC for 4 weeks, then once-a-week dose of 2.0 mg CJC-1134-PC plus mid-week dosing of placebo arm 3: Twice-a-week placebo for CJC-1134-PC

Interventions: intervention 1: 1.5 mg or 2.0 mg CJC-1134-PC intervention 2: Placebo
Intervention descriptions: intervention 1: twice-a-week intervention 2: twice-a-week

Protocol document: