Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: REGN1193

Study type: Interventional

Funder types: Industry

Identifiers

NCT02284425

R1193-DM-1402

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

Part A

Experimental group

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.

Treatment:

Drug: Placebo

Drug: REGN1193

Part B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: REGN1193