Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

REGN1193

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part B

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

Group Type EXPERIMENTAL

REGN1193

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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REGN1193

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No