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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01918865
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Obese Drug: ISIS-PTP1BRx Drug: Placebo Drug: daily OAD (metformin and/or sulfonylurea) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arms and Interventions
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Arm Intervention/treatment
Experimental: ISIS-PTP1BRx
Weekly Dosing for 26 Weeks
 Drug: ISIS-PTP1BRx
Drug: daily OAD (metformin and/or sulfonylurea)
Placebo Comparator: Placebo
Weekly Dosing for 26 Weeks
 Drug: Placebo
Drug: daily OAD (metformin and/or sulfonylurea)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918865


Locations
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Argentina
Isis Investigative Site
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Isis Investigative Site
Rosario, Santa Fe, Argentina, S2000CVD
Canada, Alberta
Isis Investigational Site
Edmonton, Alberta, Canada, T6G 2E1
Canada, British Columbia
Isis Investigational Site
Kelowna, British Columbia, Canada, V1Y 3G8
Isis Investigational Site
Vancouver, British Columbia, Canada, V6J 1S3
Canada, Ontario
Isis Investigational Site
Etobicoke, Ontario, Canada, M9R 4E1
Isis Investigational Site
Toronto, Ontario, Canada, M4G 3E8
Isis Investigative Site
Toronto, Ontario, Canada, M9V 4B4
Canada, Saskatchewan
Isis Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 3H3
South Africa
Isis Investigational Site
Centurion, Gauteng, South Africa, 0154
Isis Investigational Site
Mamelodi, Gauteng, South Africa, 0122
Isis Investigational Site
Pretoria, Gauteng, South Africa, 0001
Isis Investigational Site
Port Elizabeth, Korsten, South Africa
Isis Investigational Site
Durban, KwaZulu-Natal, South Africa
Isis Investigational Site
Middelburg, Mpumalanga, South Africa
Isis Investigational Site
Limpopo, Thabazimbi, South Africa, 0380
Isis Investigational Site
Cape Town, Western Cape, South Africa, 7570
Isis Investigational Site
Cape Town, Western Cape, South Africa
Isis Investigational Site
Benoni, South Africa, 1500
Isis Investigational Site
Bloemfontein, South Africa, 9301
Isis Investigational Site
Pretoria, South Africa, 0184
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01918865    
Other Study ID Numbers: ISIS 404173-CS2
First Posted: August 8, 2013    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: September 2014
Keywords provided by Ionis Pharmaceuticals, Inc.:
Type 2 Diabetes Mellitus
T2DM
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs