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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674466
• Other study ID #: DM200-102
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2008
• Last updated: November 18, 2008
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: ConjuChem
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• 1.5 mg or 2.0 mg CJC-1134-PC
twice-a-week
• Placebo
twice-a-week

Locations

Country	Name	City	State
Canada	Maggie Wang	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
ConjuChem

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		Screening, and Days 1, 15, 36, 57, 78, 85, and 106	No
Secondary	Incidence, duration, and intensity of Adverse Events		Continuously	Yes