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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014