An Efficacy and Safety Study of Beloranib in Obese Subjects With Type 2 Diabetes Mellitus
NCT ID: NCT02324491
Last Updated: 2016-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
152 participants
INTERVENTIONAL
2014-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ZGN-440 Injectable Suspension (1.2mg)
ZGN-440 for Injectable Suspension
ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
ZGN-440 Injectable Suspension (1.8mg)
ZGN-440 for Injectable Suspension
ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
Placebo
ZGN-440 Placebo for Injectable Suspension
ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Interventions
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ZGN-440 for Injectable Suspension
Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
ZGN-440 Placebo for Injectable Suspension
Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus
* HbA1c of 7-11%
* Fasting glucose \<15.5 mmol/L
* Treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, SGLT-2 inhibitor or any combination of these agents
* Female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive
Exclusion Criteria
* Severe hypoglycemia within the prior 6 months
* Metabolic disorders or genetic disorders linked to obesity (e.g., Prader-Willi Syndrome)
18 Years
65 Years
ALL
No
Sponsors
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Zafgen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Kim, MD
Role: STUDY_DIRECTOR
Zafgen, Inc.
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Pendlebury Research
Cardiff, New South Wales, Australia
Australian Clinical Research Network
Maroubra, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Illawara Diabetes Service
Wollongong, New South Wales, Australia
Q-Pharm
Herston, Queensland, Australia
Ipswich Research Institute
Ipswich, Queensland, Australia
AusTrials
Sherwood, Queensland, Australia
CMAX
Adelaide, South Australia, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Austin Health
Heidelberg West, Victoria, Australia
Emeritus Research
Malvern East, Victoria, Australia
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia
Keogh Institute for Medical Research
Nedlands, Western Australia, Australia
Countries
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References
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Proietto J, Malloy J, Zhuang D, Arya M, Cohen ND, de Looze FJ, Gilfillan C, Griffin P, Hall S, Nathow T, Oldfield GS, O'Neal DN, Roberts A, Stuckey BGA, Yue D, Taylor K, Kim D. Efficacy and safety of methionine aminopeptidase 2 inhibition in type 2 diabetes: a randomised, placebo-controlled clinical trial. Diabetologia. 2018 Sep;61(9):1918-1922. doi: 10.1007/s00125-018-4677-0. Epub 2018 Jul 11.
Other Identifiers
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ZAF-203
Identifier Type: -
Identifier Source: org_study_id
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