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

Ionis Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ISIS-GCGRRx - Dose Level 1; Drug: Placebo; Drug: ISIS-GCGRRx - Dose Level 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01885260

ISIS 449884-CS2

Details and patient eligibility

About

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

Enrollment: 77 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 3 patient groups, including a placebo group

ISIS-GCGRRx Dose Level 1

Experimental group

Description:

ISIS-GCGRRx Dose Level 1

Treatment:

Drug: ISIS-GCGRRx - Dose Level 1

ISIS-GCGRRx Dose Level 2

Experimental group

Description:

ISIS-GCGRRx Dose Level 2

Treatment:

Drug: ISIS-GCGRRx - Dose Level 2

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo