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

This study has been terminated.
(Business decision)
Sponsor:
Information provided by (Responsible Party):
ConjuChem
ClinicalTrials.gov Identifier:
NCT01514149
First received: October 20, 2011
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Drug: CJC-1134-PC Injection
Drug: Weekly placebo for CJC-1134-PC Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 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

Resource links provided by NLM:


Further study details as provided by ConjuChem:

Primary Outcome Measures:
  • Glycosylated hemoglobin change from baseline (CFB) to Week 18 [ Time Frame: CFB to Week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to hyperglycemia rescue [ Time Frame: Up to 18 weeks during treatment phase ] [ Designated as safety issue: No ]
  • Fasting Plasma Glucose (FPG) to Week 18 [ Time Frame: CFB to Week 18 ] [ Designated as safety issue: No ]
  • Fasting proinsulin, insulin, C-peptide, fructosamine, and glycosylated albumin CFB to Week 18 [ Time Frame: CFB to Week 18 ] [ Designated as safety issue: No ]
  • Fasting lipid profile (total cholesterol, low-density lipoprotein [LDL] cholesterol, high-density lipoprotein [HDL] cholesterol, triglycerides, very-low density lipoprotein, LDL/HDL ratio) percent CFB to Week 18 [ Time Frame: CFB to Week 18 ] [ Designated as safety issue: No ]
  • Fasting body weight CFB to Week 18 [ Time Frame: CFB to Week 18 ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: August 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  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: NCT01514149

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

No publications provided

Responsible Party: ConjuChem
ClinicalTrials.gov Identifier: NCT01514149     History of Changes
Other Study ID Numbers: DM200-103
Study First Received: October 20, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014