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

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01514149
• Other study ID #: DM200-103
• Status: Terminated
• Phase: Phase 2
• First received: October 20, 2011
• Last updated: March 8, 2012
• Start date: August 2011
• Est. completion date: March 2013

Study information

• Verified date: March 2012
• Source: ConjuChem
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

Drug:
• CJC-1134-PC Injection
CJC-1134-PC administered weekly by subcutaneous injection
• Weekly placebo for CJC-1134-PC Injection
Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection

Locations

Country	Name	City	State
Canada	Research Site	Smiths Falls	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
United States	Research Site	Altoona	Pennsylvania
United States	Research Site	Austin	Texas
United States	Research Site	Brighton	Massachusetts
United States	Research Site	Charleston	South Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Eugene	Oregon
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Henrico	Virginia
United States	Research Site	Idaho Falls	Idaho
United States	Research Site	Inglewood	California
United States	Research Site	Lexington	Kentucky
United States	Research Site	Phoenix	Arizona
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Tarzana	California
United States	Research Site	Taylors	South Carolina
United States	Research Site	Ventura	California
United States	Research Site	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ConjuChem

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycosylated hemoglobin change from baseline (CFB) to Week 18		CFB to Week 18	No
Secondary	Time to hyperglycemia rescue		Up to 18 weeks during treatment phase	No
Secondary	Fasting Plasma Glucose (FPG) to Week 18		CFB to Week 18	No
Secondary	Fasting proinsulin, insulin, C-peptide, fructosamine, and glycosylated albumin CFB to Week 18		CFB to Week 18	No
Secondary	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		CFB to Week 18	No
Secondary	Fasting body weight CFB to Week 18		CFB to Week 18	No