Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02284425

Run by

Regeneron Pharmaceuticals

People needed

72

Starts

2014-10-01

Expected to finish

2015-12-01

Last updated by the study team

2016-05-12

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Miami, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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