A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy

ConjuChem

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: 1.5 mg or 2.0 mg CJC-1134-PC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674466

DM200-102

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

• BMI: 27 to 45 kg/m2
• Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator
• Stable life-style, i.e. diet & physical activity, as determined by the Investigator
• Stable metformin daily dose ≥1000 mg for at least 3 months
• Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Twice-a-week dose of 1.5 mg CJC-1134-PC

Treatment:

Drug: 1.5 mg or 2.0 mg CJC-1134-PC

2

Experimental group

Description:

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

Treatment:

Drug: 1.5 mg or 2.0 mg CJC-1134-PC

3

Placebo Comparator group

Description:

Twice-a-week placebo for CJC-1134-PC

Treatment:

Drug: Placebo