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Completed

NCT Number: NCT01943045

Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NGM Clinical Study Site 6103, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM282

Biological

Placebo

Other

Primary outcomes

  1. Fasting Plasma Glucose

    Time frame: 28 days

Secondary outcomes

  1. HbA1c

    Time frame: 28 days

  2. Lipids

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Collaborators

  • NGM Biopharmaceuticals Australia Pty Ltd

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2013
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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