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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00638716
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
ConjuChem

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: CJC-1134-PC Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
12 weekly doses of 1.5 mg CJC-1134-PC
 Drug: 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
 Drug: CJC-1134-PC
1.5 or 2.0 mg CJC-1134-PC
Placebo Comparator: 3
12 weekly doses of placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of HbA1c From Baseline [ Time Frame: Screening and Day 85 ]
    Change from Baseline


Secondary Outcome Measures :
  1. Reduction in FPG From Baseline [ Time Frame: Screening and Day 85 ]
    Change from Baseline

  2. Reduction in Fasting Body Weight From Baseline [ Time Frame: Screening and Day 85 ]
    Change from Baseline


Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638716


Locations
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Canada, Quebec
ConjuChem Biotechnologies Inc.
Montreal, Quebec, Canada, H2X 3Y8
Sponsors and Collaborators
ConjuChem
More Information
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Responsible Party: ConjuChem
ClinicalTrials.gov Identifier: NCT00638716    
Other Study ID Numbers: DM200-101
First Posted: March 19, 2008    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: June 2, 2017
Last Verified: May 2017
Keywords provided by ConjuChem:
Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases