Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

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. Identifier: NCT02284425
Recruitment Status : Terminated
First Posted : November 6, 2014
Last Update Posted : May 12, 2016
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of REGN1193 in patients with Type 2 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: REGN1193 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Part A
Participants in Part A will consist of 4 sequential ascending dose cohorts. Each cohort will receive 1 of 4 ascending dose levels of study drug (REGN1193) or placebo.
Drug: REGN1193
Drug: Placebo
Experimental: Part B
Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Drug: REGN1193
Drug: Placebo

Primary Outcome Measures :
  1. Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Day 1 through Day 57 ]

Secondary Outcome Measures :
  1. Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time [ Time Frame: Day 1 through Day 57 ]
  2. Concentration of REGN1193 in serum over time [ Time Frame: Day 1 through Day 57 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Metformin monotherapy at a dose of ≥1000 mg/day (up to the maximum daily dose of 2550 mg per day) for ≥8 weeks prior to randomization
  2. Hemoglobin A1c value of ≥7.0% to ≤10.0%
  3. Fasting plasma glucose value ≥130 mg/dL and ≤240 mg/dL

Exclusion Criteria:

  1. Type 1 diabetes mellitus
  2. Use of insulin or oral or injectable antihyperglycemic medications during the 8 weeks prior to randomization
  3. A severe hypoglycemic event in the 6 months prior to randomization

Note: The eligibility criteria listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

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 identifier (NCT number): NCT02284425

United States, Florida
Miami, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Tennessee
Knoxville, Tennessee, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT02284425     History of Changes
Other Study ID Numbers: R1193-DM-1402
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases