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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00327626
• Other study ID #: ISIS 113715-CS12
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1, 2006
• Est. completion date: March 1, 2007

Study information

• Verified date: May 2007
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2007
• Est. primary completion date: February 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ISIS 113715

Locations

Country	Name	City	State
Israel	Soroka Medical Center	BeEr-Sheva
Israel	Rambam Medical Center	Haifa
Israel	Western Galilee Medical Center - Nahariya	Nahariya
Israel	Kaplan Medical Center	Rehovot
Israel	ZIV Hospital	Safed

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

Israel, 

Outcome

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