Clinical trial NCT01514149: Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
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
Lead sponsor: ConjuChem
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Glycosylated Hemoglobin Change From Baseline (CFB) to Week 18
timeFrame: CFB to Week 18
Secondary outcomes:
measure: Fasting Body Weight CFB to Week 18
timeFrame: CFB to Week 18
measure: Time to Hyperglycemia Rescue
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Inglewood
country: United States
facility: Research Site
state: California
city: Tarzana
country: United States
facility: Research Site
state: California
city: Ventura
country: United States
facility: Research Site
state: California
city: Wellington
country: United States
facility: Research Site
state: Florida
city: Idaho Falls
country: United States
facility: Research Site
state: Idaho
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Brighton
country: United States
facility: Research Site
state: Massachusetts
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Eugene
country: United States
facility: Research Site
state: Oregon
city: Altoona
country: United States
facility: Research Site
state: Pennsylvania
city: East Providence
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Taylors
country: United States
facility: Research Site
state: South Carolina
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Henrico
country: United States
facility: Research Site
state: Virginia
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Smiths Falls
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Chief Executive Officer
name: Patrick Soon-Shiong, MD
role: STUDY_DIRECTOR
name: Robert Henry, MD
role: PRINCIPAL_INVESTIGATOR
References: