Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

May 10, 2016 updated by: Regeneron Pharmaceuticals
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Tennessee
      • Knoxville, Tennessee, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: Placebo
Drug: REGN1193
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: Placebo
Drug: REGN1193

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame: Day 1 through Day 57
Day 1 through Day 57

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time
Time Frame: Day 1 through Day 57
Day 1 through Day 57
Concentration of REGN1193 in serum over time
Time Frame: Day 1 through Day 57
Day 1 through Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 22, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1193-DM-1402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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