Study of REGN1193 in Patients With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284425
• Other study ID #: R1193-DM-1402
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2014
• Last updated: January 8, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• REGN1193

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of treatment emergent adverse events (TEAEs)		Day 1 through Day 57	Yes
Secondary	Pharmacodynamic profile of REGN1193 as measured by plasma glucose over time		Day 1 through Day 57	No
Secondary	Concentration of REGN1193 in serum over time		Day 1 through Day 57	No