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Completed

NCT Number: NCT01918865

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Isis Investigative Site, Mar del Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISIS-PTP1BRx

Drug

Placebo

Drug

daily OAD (metformin and/or sulfonylurea)

Drug

Primary outcomes

  1. Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety

    Time frame: 38 weeks

  2. Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy

    Time frame: 27 weeks

Secondary outcomes

  1. Change in FPG, weekly average SMPG, seven-point glucose profile, lipid profile, body weight, & BMI at Week 27 compared to Baseline as a measure of efficacy

    Time frame: 27 Weeks

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of ISIS 404173 Administered Once Weekly to Obese Patients With Type 2 Diabetes Mellitus Being Treated With Metformin or Metformin Plus Sulfonylurea

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Aug 8, 2013
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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