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

NCT01514149 | Terminated Phase 2 Results

• 1 other identifier: DM200-103
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 22

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Type 2 Diabetes Mellitus; T2DM; diabetes; ConjuChem; GLP-1; Glucagon-like peptide-1; exendin-4; modified exendin-4

Outcome Measures

Primary Outcomes (1)

• Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18

  CFB to Week 18

Secondary Outcomes (2)

• Fasting Body Weight CFB to Week 18

  CFB to Week 18

• Time to Hyperglycemia Rescue

  18 weeks

Study Arms (5)

Arm 1 - Weekly CJC-1134-PC

EXPERIMENTAL

Drug: CJC-1134-PC Injection

Arm 2 - Weekly CJC-1134-PC

EXPERIMENTAL

Drug: CJC-1134-PC Injection

Arm 3 - Weekly CJC-1134-PC

EXPERIMENTAL

Drug: CJC-1134-PC Injection

Arm 4 - Weekly CJC-1134-PC

EXPERIMENTAL

Drug: CJC-1134-PC Injection

Arm 5 - Weekly Placebo

PLACEBO COMPARATOR

Drug: Weekly placebo for CJC-1134-PC Injection

Interventions

CJC-1134-PC Injection DRUG

CJC-1134-PC administered weekly by subcutaneous injection

Also known as: metformin

Arm 1 - Weekly CJC-1134-PC; Arm 2 - Weekly CJC-1134-PC; Arm 3 - Weekly CJC-1134-PC; Arm 4 - Weekly CJC-1134-PC

Weekly placebo for CJC-1134-PC Injection DRUG

Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection

Also known as: metformin

Arm 5 - Weekly Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ConjuChem: lead

Study Sites (22)

Research Site

Phoenix, Arizona, 85018, United States

Location

Research Site

Inglewood, California, 90301, United States

Location

Research Site

Tarzana, California, 91356, United States

Location

Research Site

Ventura, California, 93003, United States

Location

Research Site

Wellington, Florida, 33414, United States

Location

Research Site

Idaho Falls, Idaho, 83404, United States

Location

Research Site

Lexington, Kentucky, 40504, United States

Location

Research Site

Brighton, Massachusetts, 02135, United States

Location

Research Site

Greensboro, North Carolina, 27405, United States

Location

Research Site

Eugene, Oregon, 97401, United States

Location

Research Site

Altoona, Pennsylvania, 16602, United States

Location

Research Site

East Providence, Rhode Island, 02915, United States

Location

Research Site

Charleston, South Carolina, 29407, United States

Location

Research Site

Taylors, South Carolina, 29687, United States

Location

Research Site

Austin, Texas, 78758, United States

Location

Research Site

Dallas, Texas, 75231, United States

Location

Research Site

San Antonio, Texas, 78249, United States

Location

Research Site

Salt Lake City, Utah, 84107, United States

Location

Research Site

Henrico, Virginia, 23233, United States

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Smiths Falls, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Associate Director of Regulatory Affairs
• Organization: ConjuChem Biotechnologies Inc.

Aleece.Nolasco@nantbio.com

310-405-7549

Study Officials

• Patrick Soon-Shiong, MD

  Chief Executive Officer

  STUDY DIRECTOR

• Robert Henry, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: January 20, 2012
• Study Start: September 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 19, 2017
• Results First Posted: July 19, 2017

Record last verified: 2017-06

Locations

CA (3); US (19)