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Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea

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: NCT00327626
Recruitment Status : Withdrawn (study was never started due to regional geopolitical conflict)
First Posted : May 18, 2006
Last Update Posted : May 21, 2007
Information provided by:
Ionis Pharmaceuticals, Inc.

Brief Summary:
The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous doses (15 mg and 30 mg/day) in combination with oral antidiabetic agents (OAD) versus OAD + placebo in patients with inadequately controlled type 2 diabetes, despite ongoing maximal treatment with OAD.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ISIS 113715 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 Administered Daily in Patients With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
Study Start Date : May 2006
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Evaluate the safety, tolerability, and pharmacokinetics of two ISIS 113715 subcutaneous dosages in combination with OAD versus OAD + placebo.
  2. Examine the effect of treatment with 15 and 30 mg/day ISIS 113715 on fasting plasma glucose and HbA1c.
  3. Evaluate the effects of ISIS 113715 on insulin sensitivity, B-cell function, proinsulin/insulin ratio, fasting insulin, C-peptide and proinsulin.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male or female (post-menopausal and/or surgically sterile)
  • Aged 18 to 70 years
  • Diagnosed with type 2 diabetes mellitus of eight years or less in duration
  • Being treated with OAD at stable maximum doses [defined as at least 10 mg/day glibenclamide (preferred), or 20 mg/day glipizide, with or without at least 1,500 mg/day metformin] for at least three months prior to screening
  • Having fasting plasma glucose levels of 150-270 mg/dL and HbA1c levels of 7.5-11.0%

Exclusion Criteria:

  • Greater than 3 severe hypoglycemic episodes within six months of screen
  • Pregnant, breastfeeding, or intends to become pregnant
  • Clinical signs or symptoms of liver disease, acute, or chronic hepatitis, or ALT greater than the upper limit of normal
  • Positive hepatitis B surface antigen, hepatitis C antibody, or HIV test
  • Patients with history of renal transplantation or renal dialysis or microalbuminuria defined as urine albumin > 200 mg/day
  • History of insulin use within three months of screen
  • History of diabetic ketoacidosis
  • Treatment with any thiazolidinedione (e.g., rosiglitazone) within three months of screen
  • History of lactic acidosis while on metformin therapy
  • Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
  • Clinically significant and currently active diseases
  • Clinical significant abnormalities in medical history, physical examination, or laboratory examination

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): NCT00327626

Soroka Medical Center
BeEr-Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 31096
Western Galilee Medical Center - Nahariya
Nahariya, Israel, 22100
Kaplan Medical Center
Rehovot, Israel, 76100
ZIV Hospital
Safed, Israel, 13100
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Study Director: Mark K Wedel, MD, JD, FACP Ionis Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier: NCT00327626     History of Changes
Other Study ID Numbers: ISIS 113715-CS12
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Keywords provided by Ionis Pharmaceuticals, Inc.:
Fasting plasma glucose
Oral antidiabetic agent(s)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases