Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 Diabetes Mellitus, T2DM
Brief summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin
Interventions
DRUGISIS-GCCRRx
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
DRUGPlacebo
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 * Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening * History of diabetic ketoacidosis * Current or previous diagnosis of Gilbert's disease * 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 |
|---|---|---|
| The effect of ISIS-GCCRRx on serum fructosamine | 7 Weeks | Change from Baseline to Week 7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of ISIS-GCCRRx | 18 Weeks | By determining the incidence, severity, adverse effects, and changes in laboratory evaluations |
| The tolerability of ISIS-GCCRRx | 18 Weeks | By determining the incidence, severity, adverse effects, and changes in laboratory evaluations |
Countries
Canada, Romania, South Africa
Outcome results
None listed