Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
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 with type 2 diabetes mellitus who are currently on metformin monotherapy.

Detailed description:

Arms:
arm 1: 12 weekly doses of 1.5 mg CJC-1134-PC arm 2: 4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC arm 3: 12 weekly doses of placebo

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

Protocol document: