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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014