Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Type 2 Diabetes Mellitus T2DM diabetes ConjuChem GLP-1 Glucagon-like peptide-1 exendin-4 modified exendin-4
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 73
Healthy volunteers: no

Brief summary:
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.

Detailed description:
DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.

Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.

CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: CJC-1134-PC Injection intervention 2: Weekly placebo for CJC-1134-PC Injection
Intervention descriptions: intervention 1: CJC-1134-PC administered weekly by subcutaneous injection intervention 2: Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection

Protocol document: