Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGREGN1193
DRUGPlacebo
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment emergent adverse events (TEAEs) | Day 1 through Day 57 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time | Day 1 through Day 57 |
| Concentration of REGN1193 in serum over time | Day 1 through Day 57 |
Countries
United States
Outcome results
None listed