Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REGN1193
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- 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
- Hemoglobin A1c value of ≥7.0% to ≤10.0%
- Fasting plasma glucose value ≥130 mg/dL and ≤240 mg/dL
Exclusion Criteria:
- Type 1 diabetes mellitus
- Use of insulin or oral or injectable antihyperglycemic medications during the 8 weeks prior to randomization
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A
Part B
Arm Description
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.
Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Outcomes
Primary Outcome Measures
Incidence and severity of treatment emergent adverse events (TEAEs)
Secondary Outcome Measures
Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time
Concentration of REGN1193 in serum over time
Full Information
NCT ID
NCT02284425
First Posted
October 22, 2014
Last Updated
May 10, 2016
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02284425
Brief Title
Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A
Arm Type
Experimental
Arm Description
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.
Arm Title
Part B
Arm Type
Experimental
Arm Description
Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Intervention Type
Drug
Intervention Name(s)
REGN1193
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame
Day 1 through Day 57
Secondary Outcome Measure Information:
Title
Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time
Time Frame
Day 1 through Day 57
Title
Concentration of REGN1193 in serum over time
Time Frame
Day 1 through Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Hemoglobin A1c value of ≥7.0% to ≤10.0%
Fasting plasma glucose value ≥130 mg/dL and ≤240 mg/dL
Exclusion Criteria:
Type 1 diabetes mellitus
Use of insulin or oral or injectable antihyperglycemic medications during the 8 weeks prior to randomization
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
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