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Clinical Trials/NCT01943045
NCT01943045
Completed
Phase 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 enrollmentSeptember 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
NGM Biopharmaceuticals, Inc
Enrollment
81
Locations
9
Primary Endpoint
Fasting Plasma Glucose
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
NGM Biopharmaceuticals, Inc
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (9)

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