Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments isis-gcgrrx- dose level 1, isis-gcgrrx- dose level 2, placebo
Phase phase 2
Sponsor Ionis Pharmaceuticals, Inc.
Start date September 2015
End date December 2016
Trial size 80 participants
Trial identifier NCT02583919, ISIS 449884-CS4

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator
Arm
(Experimental)
ISIS-GCGRRx - Dose Level 1
isis-gcgrrx- dose level 1 Isis 449884
once weekly dosing for 26 weeks
(Experimental)
ISIS-GCGRRx - Dose Level 2
isis-gcgrrx- dose level 2 Isis 449884
once weekly dosing for 26 weeks
(Placebo Comparator)
Placebo
placebo
once weekly dosing for 26 weeks

Primary Outcomes

Measure
Change in HbA1C
time frame: Week 27 and subsequent timepoints

Secondary Outcomes

Measure
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
time frame: 50 weeks

Eligibility Criteria

All participants from 18 years up to 75 years old.

Inclusion Criteria: - Male or female, age 18 to 75 - BMI ≥ 25.0 kg/m2 - HbA1c ≥ 8.0% and ≤ 10.5% - Type 2 Diabetes Mellitus and on stable dose of Metformin - Agree to conduct home-based (fasted) blood glucose testing as directed Exclusion Criteria: - Clinically significant abnormalities in medical history of physical exam - Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results - History of solid organ transplant or renal dialysis - History of liver disease - History of greater than 3 episodes of severe hypoglycemia within 6 months of screening - Treatment with any other antidiabetic drug(s) other than metformin within 3 months of screening - History of diabetic ketoacidosis - Any other significant illness or condition that may interfere with the patient participating or completing the study - Inability or unwillingness to comply with protocol or study procedures

Additional Information

Official title Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc..