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
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
1 other identifier
interventional
122
1 country
1
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 with type 2 diabetes mellitus who are currently on metformin monotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Feb 2008
Shorter than P25 for phase_2 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 13, 2008
CompletedFirst Posted
Study publicly available on registry
March 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
June 2, 2017
CompletedJune 2, 2017
May 1, 2017
9 months
March 13, 2008
May 2, 2017
May 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of HbA1c From Baseline
Change from Baseline
Screening and Day 85
Secondary Outcomes (2)
Reduction in FPG From Baseline
Screening and Day 85
Reduction in Fasting Body Weight From Baseline
Screening and Day 85
Study Arms (3)
1
EXPERIMENTAL12 weekly doses of 1.5 mg CJC-1134-PC
2
EXPERIMENTAL4 weekly doses of 1.5 mg CJC-1134-PC followed by 8 weekly doses of 2.0 mg CJC-1134-PC
3
PLACEBO COMPARATOR12 weekly doses of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ConjuChemlead
Study Sites (1)
ConjuChem Biotechnologies Inc.
Montreal, Quebec, H2X 3Y8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director of Regulatory Affairs
- Organization
- ConjuChem Biotechnologies Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2008
First Posted
March 19, 2008
Study Start
February 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
June 2, 2017
Results First Posted
June 2, 2017
Record last verified: 2017-05