This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, obese
Treatments isis-ptp1brx, placebo, daily oad (metformin and/or sulfonylurea)
Phase phase 2
Sponsor Isis Pharmaceuticals
Start date August 2013
End date September 2015
Trial size 75 participants
Trial identifier NCT01918865, ISIS 404173-CS2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Weekly Dosing for 26 Weeks
daily oad (metformin and/or sulfonylurea)
(Placebo Comparator)
Weekly Dosing for 26 Weeks
daily oad (metformin and/or sulfonylurea)

Primary Outcomes

Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety
time frame: 38 weeks
Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy
time frame: 27 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Isis Pharmaceuticals.