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 - Full Text View

Sponsored by:	ConjuChem
Information provided by:	ConjuChem
ClinicalTrials.gov Identifier:	NCT00638716

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 II

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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

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
1: Experimental 12 weekly doses of 1.5 mg CJC-1134-PC	Drug: CJC-1134-PC 1.5 or 2.0 mg CJC-1134-PC
2: Experimental 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
3: Placebo Comparator 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

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

Keywords provided by ConjuChem:

Type 2 Diabetes Mellitus, incretins, GLP-1, HbA1c, metformin

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009