Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes

Phase 2

Completed

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

• Registration Number: NCT02824003
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Primary Completion: 2016-12-15
• Study Completion: 2017-05-22
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Male or female, age 18 to 75
• BMI ≥ 25.0 kg/m2 < 36.0 kg/m2
• HbA1c ≥ 7.5% and ≤ 10.5%
• Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed
• 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
• History of liver transplantation 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, SU or DPPIV 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
Placebo	Placebo	once weekly dosing for 13 weeks
ISIS-GCGRRx	ISIS-GCGRRx	ISIS-GCGRRx once weekly dosing for 13 weeks

Primary Outcome Measures

Name	Time	Method
Change in fasting hepatic lipid content	Week 14	Change from Baseline
Change in fasting hepatic glycogen content	Week 14	Change from Baseline

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations	38 weeks	Safety results in patients dosed with ISIS 449884 will be compared with those from patients dosed with placebo

Trial Locations

Locations (1)

Ionis Investigator Site; 🇦🇹 Vienna, Austria