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

Ionis Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: ISIS-GCGRRx

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02824003

ISIS 449884-CS3

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 -