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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: ISIS-GCGRRx- Dose Level 1; Drug: ISIS-GCGRRx- Dose Level 2; Drug: Placebo

• Registration Number: NCT02583919
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-12
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2016-12-15
• Study Completion: 2017-05-11
• Status Verified: 2018-06
• Disposition First Submitted: 2018-06-20
• Disposition First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Disposition First Posted: 2018-06-25
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISIS-GCGRRx - Dose Level 1	ISIS-GCGRRx- Dose Level 1	ISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 2	ISIS-GCGRRx- Dose Level 2	ISIS-GCGRRx - Dose Level 2
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in HbA1C	Week 27 and subsequent timepoints	Change from Baseline

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort	50 weeks	Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo

Trial Locations

Locations (2)

Ionis Investigational Site; 🇺🇸 Olympia, Washington, United States

Isis Investigational Site; 🇺🇸 Spring Valley, California, United States