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Phase 2 Study of NGM282 in Patients With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01943045
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
NGM Biopharmaceuticals Australia Pty Ltd
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Biological: NGM282 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NGM282 Dose 1
NGM Dose 1
Biological: NGM282
Experimental: NGM282 Dose 2
NGM Dose 2
Biological: NGM282
Experimental: NGM282 Dose 3
NGM Dose 3
Biological: NGM282
Placebo Comparator: Placebo
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Fasting Plasma Glucose [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: 28 days ]
  2. Lipids [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943045


Locations
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Australia, Victoria
NGM Clinical Study Site 6103
Melbourne, Victoria, Australia
NGM Clinical Study Site 6104
Melbourne, Victoria, Australia
Australia, Western Australia
NGM Clinical Study Site 6101
Perth, Western Australia, 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, New Zealand
Sponsors and Collaborators
NGM Biopharmaceuticals, Inc
NGM Biopharmaceuticals Australia Pty Ltd
Investigators
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Study Director: Alex M DePaoli, MD NGM Biopharmaceuticals, Inc
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NGM Biopharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01943045    
Other Study ID Numbers: 13-0102
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases