Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 72
- Primary Endpoint
- Incidence and severity of treatment emergent adverse events (TEAEs)
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Part B
Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Intervention: Placebo
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.
Intervention: REGN1193
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.
Intervention: Placebo
Part B
Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Intervention: REGN1193
Outcomes
Primary Outcomes
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame: Day 1 through Day 57
Secondary Outcomes
- 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)