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

Ionis Pharmaceuticals logo

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

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

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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