- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638716
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus Who Are Currently on Metformin Monotherapy (DM200-101)
May 2, 2017 updated by: ConjuChem
A Randomized, Double-blind, Placebo-controlled, Multiple-dose, Phase II Study to Evaluate the Efficacy and Safety of 3 Months of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 3Y8
- ConjuChem Biotechnologies Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
12 weekly doses of 1.5 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
|
Experimental: 2
4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
|
1.5 or 2.0 mg CJC-1134-PC
|
Placebo Comparator: 3
12 weekly doses of placebo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of HbA1c From Baseline
Time Frame: Screening and Day 85
|
Change from Baseline
|
Screening and Day 85
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in FPG From Baseline
Time Frame: Screening and Day 85
|
Change from Baseline
|
Screening and Day 85
|
Reduction in Fasting Body Weight From Baseline
Time Frame: Screening and Day 85
|
Change from Baseline
|
Screening and Day 85
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
March 13, 2008
First Submitted That Met QC Criteria
March 18, 2008
First Posted (Estimate)
March 19, 2008
Study Record Updates
Last Update Posted (Actual)
June 2, 2017
Last Update Submitted That Met QC Criteria
May 2, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DM200-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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