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

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ClinicalTrials.gov Identifier: NCT01514149
Recruitment Status : Terminated (Business decision)
First Posted : January 20, 2012
Results First Posted : July 19, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
ConjuChem

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus (T2DM) Drug: CJC-1134-PC Injection Drug: Weekly placebo for CJC-1134-PC Injection Phase 2

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  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 - Weekly CJC-1134-PC Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Name: metformin
Experimental: Arm 2 - Weekly CJC-1134-PC Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Name: metformin
Experimental: Arm 3 - Weekly CJC-1134-PC Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Name: metformin
Experimental: Arm 4 - Weekly CJC-1134-PC Drug: CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
Other Name: 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 Name: metformin



Primary Outcome Measures :
  1. Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 [ Time Frame: CFB to Week 18 ]

Secondary Outcome Measures :
  1. Fasting Body Weight CFB to Week 18 [ Time Frame: CFB to Week 18 ]
  2. Time to Hyperglycemia Rescue [ Time Frame: 18 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514149


  Show 22 Study Locations
Sponsors and Collaborators
ConjuChem
Investigators
Study Director: Patrick Soon-Shiong, MD Chief Executive Officer
Principal Investigator: Robert Henry, MD

Responsible Party: ConjuChem
ClinicalTrials.gov Identifier: NCT01514149     History of Changes
Other Study ID Numbers: DM200-103
First Posted: January 20, 2012    Key Record Dates
Results First Posted: July 19, 2017
Last Update Posted: July 19, 2017
Last Verified: June 2017

Keywords provided by ConjuChem:
Type 2 Diabetes Mellitus
T2DM
diabetes
ConjuChem
GLP-1
Glucagon-like peptide-1
exendin-4
modified exendin-4

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