Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Biological: NGM282; Other: Placebo

• Registration Number: NCT01943045
• Lead Sponsor: NGM Biopharmaceuticals, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-14
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
NGM282 Dose 3	NGM282	NGM Dose 3
Placebo	Placebo	Placebo
NGM282 Dose 1	NGM282	NGM Dose 1
NGM282 Dose 2	NGM282	NGM Dose 2

Primary Outcome Measures

Name	Time	Method
Fasting Plasma Glucose	28 days

Secondary Outcome Measures

Name	Time	Method
HbA1c	28 days
Lipids	28 days

Trial Locations

Locations (9)

NGM Clinical Study Site 6405; 🇳🇿 Auckland, New Zealand

NGM Clinical Study Site 6401; 🇳🇿 Christchurch, New Zealand

NGM Clinical Study Site 6403; 🇳🇿 Auckland, New Zealand

NGM Clinical Study Site 6406; 🇳🇿 Dunedin, New Zealand

NGM Clinical Study Site 6404; 🇳🇿 Tauranga, New Zealand

NGM Clinical Study Site 6402; 🇳🇿 Wellington, New Zealand

NGM Clinical Study Site 6101; 🇦🇺 Perth, Western Australia, Australia

NGM Clinical Study Site 6103; 🇦🇺 Melbourne, Victoria, Australia

NGM Clinical Study Site 6104; 🇦🇺 Melbourne, Victoria, Australia