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

Phase 2

Completed

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

• Registration Number: NCT01885260
• 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 + metformin

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-24
• Study Start: 2013-07
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Status Verified: 2016-06
• Disposition First Submitted: 2016-06-14
• Disposition First Submitted QC: 2016-06-14
• Disposition First Posted: 2016-06-16
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Male or female, age 18 to 75
• BMI greater than or equal to 25
• HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
• Type 2 Diabetes Mellitus and on stable dose of oral metformin
• Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria

• Clinically significant abnormalities in medical history or physical exam
• Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
• History of renal transplantation or renal dialysis
• History of liver disease
• History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
• Use of oral anti-diabetic medication 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
Placebo	Placebo	Placebo
ISIS-GCGRRx Dose Level 2	ISIS-GCGRRx - Dose Level 2	ISIS-GCGRRx Dose Level 2

Primary Outcome Measures

Name	Time	Method
The effect of ISIS-GCGRRx on serum fructosamine	14 Weeks	Change from Baseline to Week 14

Secondary Outcome Measures

Name	Time	Method
The safety of ISIS-GCGRRx	25 Weeks	By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
The tolerability of ISIS-GCGRRx	25 Weeks	By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations

Trial Locations

Locations (1)

Isis Investigational Site; 🇿🇦 Western Cape, South Africa