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

Phase 2

Terminated

• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Interventions: Drug: CJC-1134-PC Injection; Drug: Weekly placebo for CJC-1134-PC Injection

• Registration Number: NCT01514149
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-20
• Primary Completion: 2012-05
• Study Completion: 2013-03
• Results First Submitted: 2017-05-02
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Results First Posted: 2017-07-19
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Weekly CJC-1134-PC	CJC-1134-PC Injection	-
Arm 1 - Weekly CJC-1134-PC	CJC-1134-PC Injection	-
Arm 3 - Weekly CJC-1134-PC	CJC-1134-PC Injection	-
Arm 4 - Weekly CJC-1134-PC	CJC-1134-PC Injection	-
Arm 5 - Weekly Placebo	Weekly placebo for CJC-1134-PC Injection	-

Primary Outcome Measures

Name	Time	Method
Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18	CFB to Week 18

Secondary Outcome Measures

Name	Time	Method
Time to Hyperglycemia Rescue	18 weeks
Fasting Body Weight CFB to Week 18	CFB to Week 18

Trial Locations

Locations (1)

Research Site; 🇨🇦 Toronto, Ontario, Canada