Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals

Criteria

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.