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This study has been withdrawn prior to enrollment.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:
Isis Pharmaceuticals
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00327626
First received: May 16, 2006
Last updated: May 18, 2007
Last verified: May 2007
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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
Keywords provided by Isis Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
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 October 16, 2012