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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Drug: CJC-1134-PC Injection
* Drug: Weekly placebo for CJC-1134-PC Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Weekly CJC-1134-PC<br> | Drug: CJC-1134-PC Injection<br>* CJC-1134-PC administered weekly by subcutaneous injection<br>* Other names: metformin;|
| Experimental: Arm 2 - Weekly CJC-1134-PC<br> | Drug: CJC-1134-PC Injection<br>* CJC-1134-PC administered weekly by subcutaneous injection<br>* Other names: metformin;|
| Experimental: Arm 3 - Weekly CJC-1134-PC<br> | Drug: CJC-1134-PC Injection<br>* CJC-1134-PC administered weekly by subcutaneous injection<br>* Other names: metformin;|
| Experimental: Arm 4 - Weekly CJC-1134-PC<br> | Drug: CJC-1134-PC Injection<br>* CJC-1134-PC administered weekly by subcutaneous injection<br>* Other names: metformin;|
| Placebo Comparator: Arm 5 - Weekly Placebo<br> | Drug: Weekly placebo for CJC-1134-PC Injection<br>* Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection<br>* Other names: metformin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18 |  | CFB to Week 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Body Weight CFB to Week 18 |  | CFB to Week 18 | 
| Time to Hyperglycemia Rescue |  | 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, T2DM, diabetes, ConjuChem, GLP-1, Glucagon-like peptide-1, exendin-4, modified exendin-4