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

This study has been withdrawn prior to enrollment.
(study was never started due to regional geopolitical conflict)
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00327626
First received: May 16, 2006
Last updated: May 18, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: ISIS 113715
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Isis Pharmaceuticals:

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

Estimated Enrollment: 96
Study Start Date: May 2006
Estimated Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327626

Locations
Israel
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
Isis Pharmaceuticals
Investigators
Study Director: Mark K Wedel, MD, JD, FACP Isis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00327626     History of Changes
Other Study ID Numbers: ISIS 113715-CS12
Study First Received: May 16, 2006
Last Updated: May 18, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Isis Pharmaceuticals:
Fasting plasma glucose
HbA1c
Oral antidiabetic agent(s)

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

ClinicalTrials.gov processed this record on April 15, 2014