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
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: CJC-1134-PC
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by ConjuChem:

Primary Outcome Measures:
  • HbA1c [ Time Frame: Screening, and Days 1, 15, 36, 57, 78, 85, and 106 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence, duration, and intensity of Adverse Events [ Time Frame: Continuously ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638716

Locations
Canada, Quebec
ConjuChem Biotechnologies Inc.
Montreal, Quebec, Canada, H2X 3Y8
Sponsors and Collaborators
ConjuChem
  More Information

No publications provided

Responsible Party: Maggie Wang, MD/ Senior Director of Clinical Research, ConjuChem Biotechnologies Inc.
ClinicalTrials.gov Identifier: NCT00638716     History of Changes
Other Study ID Numbers: DM200-101
Study First Received: March 13, 2008
Last Updated: November 18, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by ConjuChem:
Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014