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
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
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

Male or female 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 October 2016.
Information provided to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc..