NCT01885260

Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCGRRx in combination with metformin versus placebo + metformin

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ISIS-GCGRRx - Dose Level 1	3 doses on alternate days during the first week and then once weekly for 12 weeks
DRUG	ISIS-GCGRRx - Dose Level 2	3 doses on alternate days during the first week and then once weekly for 12 weeks
DRUG	Placebo	3 doses on alternate days during the first week and then once weekly for 12 weeks

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-05-01
• Completion: 2014-11-01
• First posted: 2013-06-24
• Last updated: 2016-07-04

Locations

24 sites across 2 countries: United States, South Africa