NCT01943045CompletedPhase 2
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Activity of NGM282 Administered for 28 Days to Patients With Type 2 Diabetes Mellitus
NGM Biopharmaceuticals, Inc9 sites in 2 countries81 target enrollmentStarted: September 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 9
- Primary Endpoint
- Fasting Plasma Glucose
Study Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females, between 18 and 70 years of age, inclusive
- •BMI range of 24-40 kg/m2, inclusive
- •No active coronary artery disease
- •Resting heart rate in the range of 40-100 bpm
Exclusion Criteria
- •Diagnosis of Type 1 diabetes
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
Outcomes
Primary Outcomes
Fasting Plasma Glucose
Time Frame: 28 days
Secondary Outcomes
- HbA1c(28 days)
- Lipids(28 days)
Investigators
Study Sites (9)
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