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NCT01943045 Clinical Trial

Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01943045
Other study ID # 13-0102
Secondary ID
Status Completed
Phase Phase 2
First received September 11, 2013
Last updated November 14, 2015
Start date September 2013
Est. completion date September 2014

Study information
Verified date November 2015
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Biological:
• NGM282

Other:
• Placebo

Locations
Country Name City State
Australia NGM Clinical Study Site 6103 Melbourne Victoria
Australia NGM Clinical Study Site 6104 Melbourne Victoria
Australia NGM Clinical Study Site 6101 Perth Western Australia
New Zealand NGM Clinical Study Site 6403 Auckland
New Zealand NGM Clinical Study Site 6405 Auckland
New Zealand NGM Clinical Study Site 6401 Christchurch
New Zealand NGM Clinical Study Site 6406 Dunedin
New Zealand NGM Clinical Study Site 6404 Tauranga
New Zealand NGM Clinical Study Site 6402 Wellington

Sponsors (2)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc NGM Biopharmaceuticals Australia Pty Ltd

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fasting Plasma Glucose 28 days No
Secondary HbA1c 28 days No
Secondary Lipids 28 days No
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