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Completed

NCT Number: NCT00638716

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ConjuChem Biotechnologies Inc.

Montreal, Quebec, H2X 3Y8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

CJC-1134-PC

Drug

1.5 or 2.0 mg CJC-1134-PC

Placebo

Drug

Placebo

Primary outcomes

  1. Reduction of HbA1c From Baseline

    Time frame: Screening and Day 85

    Change from Baseline

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

ConjuChem

Industry

Registry information

Official study 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

Acronym: DM200-101

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 19, 2008
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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