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Clinical Trials/NCT00674466
NCT00674466
Completed
Phase 2

A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Twice-a-week Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy

ConjuChem1 site in 1 country90 target enrollmentMarch 2008
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ConditionsType 2 Diabetes Mellitus
Interventions1.5 mg or 2.0 mg CJC-1134-PCPlacebo
Drugs1.5 mg or 2.0 mg CJC-1134-PCPlacebo

Overview

Phase
Phase 2
Intervention
1.5 mg or 2.0 mg CJC-1134-PC
Conditions
Type 2 Diabetes Mellitus
Sponsor
ConjuChem
Enrollment
90
Locations
1
Primary Endpoint
Reduction of HbA1c From Baseline
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
November 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ConjuChem
Responsible Party
Sponsor

Eligibility Criteria

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%

Exclusion Criteria

  • Not provided

Arms & Interventions

1

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

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

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

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

3

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

Intervention: Placebo

Outcomes

Primary Outcomes

Reduction of HbA1c From Baseline

Time Frame: Screening and Day 85

Change from baseline

Secondary Outcomes

  • Reduction in Fasting Body Weight From Baseline(Screening and Day 85)
  • Reduction in Fasting Plasma Glucose From Baseline(Screening and Day 85)

Study Sites (1)

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