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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918865
• Other study ID #: ISIS 404173-CS2
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2013
• Last updated: February 27, 2015
• Start date: August 2013
• Est. completion date: February 2015

Study information

• Verified date: September 2014
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaSouth Africa: Medicines Control CouncilRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obese
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ISIS-PTP1BRx

• Placebo

• daily OAD (metformin and/or sulfonylurea)

Locations

Country	Name	City	State
Argentina	Isis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Isis Investigative Site	Rosario	Santa Fe
Canada	Isis Investigational Site	Edmonton	Alberta
Canada	Isis Investigational Site	Etobicoke	Ontario
Canada	Isis Investigational Site	Kelowna	British Columbia
Canada	Isis Investigational Site	Saskatoon	Saskatchewan
Canada	Isis Investigational Site	Toronto	Ontario
Canada	Isis Investigative Site	Toronto	Ontario
Canada	Isis Investigational Site	Vancouver	British Columbia
South Africa	Isis Investigational Site	Benoni
South Africa	Isis Investigational Site	Bloemfontein
South Africa	Isis Investigational Site	Cape Town	Western Cape
South Africa	Isis Investigational Site	Cape Town	Western Cape
South Africa	Isis Investigational Site	Centurion	Gauteng
South Africa	Isis Investigational Site	Durban	KwaZulu-Natal
South Africa	Isis Investigational Site	Limpopo	Thabazimbi
South Africa	Isis Investigational Site	Mamelodi	Gauteng
South Africa	Isis Investigational Site	Middelburg	Mpumalanga
South Africa	Isis Investigational Site	Port Elizabeth	Korsten
South Africa	Isis Investigational Site	Pretoria	Gauteng
South Africa	Isis Investigational Site	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Argentina,  Canada,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, severity, dose-relationship of adverse effects, and changes in laboratory evaluations as a measure of safety		38 weeks	Yes
Primary	Change in plasma HbA1c levels at Week 27 compared to Baseline as a measure of efficacy		27 weeks	No
Secondary	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		27 Weeks	No