Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy

June 21, 2017 updated by: ConjuChem

A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Dose-Ranging Study to Evaluate the Efficacy and Safety of 17 Weeks of Weekly Injections of CJC-1134-PC in Patients With Type 2 Diabetes Mellitus on Metformin Monotherapy

DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus (T2DM) on metformin monotherapy. This study will be a randomized, double-blind comparison of CJC-1134-PC versus placebo. Patients taking metformin will continue to take their metformin at the same dose for the duration of the study.

Patients with T2DM, who meet all the inclusion criteria and none of the exclusion criteria, will be randomly assigned to a treatment arm. All patients will undergo weekly clinic visits to receive 17 weeks of study treatment, including the titration period.

CJC-1134-PC or placebo treatment will be administered weekly by subcutaneous injection in the abdomen to patients in a fasting state. Patients will be closely monitored and evaluated for toxicity on an ongoing basis.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Ontario
      • Smiths Falls, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Research Site
    • California
      • Inglewood, California, United States, 90301
        • Research Site
      • Tarzana, California, United States, 91356
        • Research Site
      • Ventura, California, United States, 93003
        • Research Site
    • Florida
      • Wellington, Florida, United States, 33414
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Research Site
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Research Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Research Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Research Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02915
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Research Site
      • Taylors, South Carolina, United States, 29687
        • Research Site
    • Texas
      • Austin, Texas, United States, 78758
        • Research Site
      • Dallas, Texas, United States, 75231
        • Research Site
      • San Antonio, Texas, United States, 78249
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Research Site
    • Virginia
      • Henrico, Virginia, United States, 23233
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women 18 to 70 years of age, inclusive
  • Body mass index of 27 to 45 kg/m2
  • Diagnosed with T2DM for at least 6 months before screening
  • Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before screening
  • FPG ≤240 mg/dL at screening
  • HbA1c ≥7.0% and ≤11% at screening
  • A 12-lead electrocardiogram recording without clinically significant arrhythmia, left bundle-branch block, or corrected QT interval

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Use of a weight control treatment, including over-the-counter medications (includes herbal supplements), or a significant change in body weight (at least ±10%) in the 3 months before screening
  • Treatment with any oral antidiabetic agent other than metformin within the 3 months before screening
  • Treatment with insulin for longer than 1 week within the 3 months before screening or any treatment with insulin within the 2 weeks before screening
  • Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin therapy
  • Receipt of any experimental drug in a clinical trial within 30 days before administration of study drug or receipt of any investigational antidiabetic product within 3 months before screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Weekly CJC-1134-PC
Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Names:
  • metformin
Experimental: Arm 2 - Weekly CJC-1134-PC
Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Names:
  • metformin
Experimental: Arm 3 - Weekly CJC-1134-PC
Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Names:
  • metformin
Experimental: Arm 4 - Weekly CJC-1134-PC
Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Names:
  • metformin
Placebo Comparator: Arm 5 - Weekly Placebo
Drug: Weekly placebo for CJC-1134-PC Injection
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Other Names:
  • metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
Time Frame: CFB to Week 18
CFB to Week 18

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting Body Weight CFB to Week 18
Time Frame: CFB to Week 18
CFB to Week 18
Time to Hyperglycemia Rescue
Time Frame: 18 weeks
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConjuChem

Investigators

  • Study Director: Patrick Soon-Shiong, MD, Chief Executive Officer
  • Principal Investigator: Robert Henry, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimate)

January 20, 2012

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM200-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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