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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)

This study has been completed.
Sponsor:
Information provided by:
ConjuChem
ClinicalTrials.gov Identifier:
NCT00638716
First received: March 13, 2008
Last updated: November 18, 2008
Last verified: November 2008

March 13, 2008
November 18, 2008
February 2008
November 2008   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: Screening, and Days 1, 15, 36, 57, 78, 85, and 106 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00638716 on ClinicalTrials.gov Archive Site
Incidence, duration, and intensity of Adverse Events [ Time Frame: Continuously ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: CJC-1134-PC
    1.5 or 2.0 mg CJC-1134-PC
  • Drug: Placebo
    Placebo
  • Experimental: 1
    12 weekly doses of 1.5 mg CJC-1134-PC
    Intervention: Drug: 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
    Intervention: Drug: CJC-1134-PC
  • Placebo Comparator: 3
    12 weekly doses of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
November 2008
November 2008   (final data collection date for primary outcome measure)

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%
Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00638716
DM200-101
Yes
Maggie Wang, MD/ Senior Director of Clinical Research, ConjuChem Biotechnologies Inc.
ConjuChem
Not Provided
Not Provided
ConjuChem
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP