Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
72
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus-type-2
Started Oct 2014
Longer than P75 for phase_1 diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 22, 2014
CompletedFirst Posted
Study publicly available on registry
November 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 12, 2016
May 1, 2016
1.2 years
October 22, 2014
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and severity of treatment emergent adverse events (TEAEs)
Day 1 through Day 57
Secondary Outcomes (2)
Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time
Day 1 through Day 57
Concentration of REGN1193 in serum over time
Day 1 through Day 57
Study Arms (2)
Part A
EXPERIMENTALParticipants 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.
Part B
EXPERIMENTALParticipants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Miami, Florida, United States
Unknown Facility
Atlanta, Georgia, United States
Unknown Facility
Knoxville, Tennessee, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2014
First Posted
November 6, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 12, 2016
Record last verified: 2016-05