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

Ionis Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Placebo

Drug: ISIS-GCCRRx

Study type

Interventional

Funder types

Industry

Identifiers

NCT01968265

2013-002172-40 (EudraCT Number)

ISIS 426115-CS2

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin

Enrollment

38 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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