Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes

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Ionis Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Obese
Type 2 Diabetes Mellitus

Treatments

Drug: ISIS-PTP1BRx
Drug: Placebo
Drug: daily OAD (metformin and/or sulfonylurea)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01918865
ISIS 404173-CS2

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and efficacy of ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral antidiabetic drug/s.

Enrollment

92 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Body mass index (BMI) >/= 27 kg/m2
  • HbA1c between 7.5% and 10.5% (inclusive)
  • C-Peptide (fasting) greater than or equal to 500 pmol/L
  • On stable dose of metformin alone or in combination with a stable dose of sulfonylurea for >/= 3 months prior to screening, and remain on stable dose throughout the study
  • Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion criteria

  • Clinically significant abnormalities in medical history or physical exam
  • Serum creatinine > ULN at Screening
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT or AST > 1.5x ULN at Screening
  • History of renal transplantation or renal dialysis
  • GFR < 60 mL/min at Screening
  • History of diabetic ketoacidosis
  • History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
  • Allergy to sulfur containing drugs
  • Treatment with other drugs or medications not allowed per study specific Disallowed Concomitant Medicines
  • 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

92 participants in 2 patient groups, including a placebo group

ISIS-PTP1BRx
Experimental group
Description:
Weekly Dosing for 26 Weeks
Treatment:
Drug: daily OAD (metformin and/or sulfonylurea)
Drug: ISIS-PTP1BRx
Placebo
Placebo Comparator group
Description:
Weekly Dosing for 26 Weeks
Treatment:
Drug: daily OAD (metformin and/or sulfonylurea)
Drug: Placebo

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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