Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

Phase 1

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: REGN1193; Drug: Placebo

• Registration Number: NCT02284425
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part B	REGN1193	Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Part A	Placebo	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.
Part B	Placebo	Participants in Part B will consist of a single cohort and will receive three doses of study drug (REGN1193) or placebo.
Part A	REGN1193	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.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of treatment emergent adverse events (TEAEs)	Day 1 through Day 57

Secondary Outcome Measures

Name	Time	Method
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