Back to resultsA Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
1.5 mg or 2.0 mg CJC-1134-PC
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring GLP-1, incretin, type 2 diabetes
Eligibility 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%
Sites / Locations
- Maggie Wang
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Twice-a-week dose of 1.5 mg CJC-1134-PC
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
Twice-a-week placebo for CJC-1134-PC
Outcomes
Primary Outcome Measures
Reduction of HbA1c From Baseline
Change from baseline
Secondary Outcome Measures
Reduction in Fasting Plasma Glucose From Baseline
Change from baseline
Reduction in Fasting Body Weight From Baseline
Change from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00674466
Brief Title
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ConjuChem
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
GLP-1, incretin, type 2 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Twice-a-week dose of 1.5 mg CJC-1134-PC
Arm Title
2
Arm Type
Experimental
Arm 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
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Twice-a-week placebo for CJC-1134-PC
Intervention Type
Drug
Intervention Name(s)
1.5 mg or 2.0 mg CJC-1134-PC
Intervention Description
twice-a-week
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
twice-a-week
Primary Outcome Measure Information:
Title
Reduction of HbA1c From Baseline
Description
Change from baseline
Time Frame
Screening and Day 85
Secondary Outcome Measure Information:
Title
Reduction in Fasting Plasma Glucose From Baseline
Description
Change from baseline
Time Frame
Screening and Day 85
Title
Reduction in Fasting Body Weight From Baseline
Description
Change from baseline
Time Frame
Screening and Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie Wang, MD
Organizational Affiliation
ConjuChem Biotechnologies Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Maggie Wang
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3Y8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
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