Type 2 Diabetes
Conditions
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.
Interventions
DRUGISIS-GCGRRx
once weekly dosing for 13 weeks
DRUGPlacebo
once weekly dosing for 13 weeks
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fasting hepatic glycogen content | Week 14 | Change from Baseline |
| Change in fasting hepatic lipid content | Week 14 | Change from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria
Outcome results
None listed