Status:
TERMINATED
Study of REGN1193 in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
25-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02284425
Start Date
October 1 2014
End Date
December 1 2015
Last Update
May 12 2016
Active Locations (3)
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1
Miami, Florida, United States
2
Atlanta, Georgia, United States
3
Knoxville, Tennessee, United States