Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior Treatment

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Activity of ISIS 113715 in Patients With Type 2 Diabetes Mellitus Who Have Not Received Prior Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330330
• Other study ID #: ISIS 113715-CS7
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2006
• Last updated: February 4, 2008
• Start date: February 2003
• Est. completion date: August 2006

Study information

• Verified date: February 2008
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety, tolerability, and pharmacokinetics of five ISIS 113715 intravenous dose cohorts in drug-naïve type 2 diabetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus of less than 5 years in duration

• Have never received hypoglycemic therapy

• Aged 18 to 65 years

• Fasting blood glucose between 130 and 220 mg/dL (7.2 to 12.2 mmol/L) for Cohorts A-D and between 140 and 220 mg/dL (7.8 to 12.2 mmol/L) for Cohort E

• HbA1c between 6.8 and 10.0% for Cohorts A-D and between 7.5 and 11.0% for Cohort E

• Body Mass index > 25 and < 35 kg m -2

Exclusion Criteria:

• Medication that may affect glucose homeostasis (e.g. systemic glucocorticoid) within one month of screening

• Clinically significant abnormalities in medical history or physical exam

• Clinically significant abnormalities on laboratory examination

• History of HIV infection

• Active infection requiring antiviral or antimicrobial therapy

• Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for > one year at the time of screening)

• Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in or interfere with compliance

• Alcohol or drug abuse

• Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days of screening

• Abnormal serum creatinine concentration defined as > 1.5 mg/dL (132.6 micro mol/L) for males and > 1.2 mg/dL (106 micro mol/L) for females

• Medications that may affect coagulation (heparin, warfarin, etc.) with the exception of acetylsalicylic acid or non-steroidal anti-inflammatory agents.

• Allergy to sulfur-containing medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• ISIS 113715

Locations

Country	Name	City	State
Poland	NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny	Bialystok
Poland	Prywatna Praktyka Lekarska	Radom
Poland	Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie	Wolomin
Russian Federation	Chair of Endocrinology and Diabetology Central Clinical Hospital of the Ministry of Communications of RF	Moscow
Russian Federation	Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians	Moscow
Russian Federation	Close Corporation "MEDSI"	Moscow
Russian Federation	Endocrinology Scientific Centre of RAMS	Moscow
Russian Federation	Medical Institution "Polyclinic OAOA Gazprom"	Moscow
Russian Federation	Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky	Moscow
Russian Federation	Clinic of Therapy of Postgraduate Education named after N.S. Molchanov	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of ISIS 113715
Primary	To evaluate the pharmacokinetic profile of ISIS 113715
Primary	To evaluate the pharmacologic activity of ISIS 113715