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

NCT00327626 | Withdrawn Phase 2

• 1 other identifier: ISIS 113715-CS12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Fasting plasma glucose; HbA1c; Oral antidiabetic agent(s)

Outcome Measures

Primary Outcomes (3)

• 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.

Interventions

ISIS 113715 DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Ionis Pharmaceuticals, Inc.: lead

Study Sites (5)

Soroka Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Western Galilee Medical Center - Nahariya

Nahariya, 22100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

ZIV Hospital

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ISIS-113715

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mark K Wedel, MD, JD, FACP

  Ionis Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 18, 2006
• Study Start: May 1, 2006
• Primary Completion: February 1, 2007
• Study Completion: March 1, 2007
• Last Updated: December 5, 2022

Record last verified: 2007-05

Locations

IL (5)