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

February 4, 2008 updated by: Ionis Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Bialystok, Poland, 15-435
        • NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny
      • Radom, Poland, 26-600
        • Prywatna Praktyka Lekarska
      • Wolomin, Poland, 05-200
        • Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie
  • Russian Federation
      • Moscow, Russian Federation, 123056
        • Close Corporation "MEDSI"
      • Moscow, Russian Federation, 109125
        • Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians
      • Moscow, Russian Federation, 117036
        • Endocrinology Scientific Centre of RAMS
      • Moscow, Russian Federation, 117420
        • Medical Institution "Polyclinic OAOA Gazprom"
      • Moscow, Russian Federation, 125315
        • Chair of Endocrinology and Diabetology Central Clinical Hospital of the Ministry of Communications of RF
      • Moscow, Russian Federation, 129110
        • Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky
      • St. Petersburg, Russian Federation, 198013
        • Clinic of Therapy of Postgraduate Education named after N.S. Molchanov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate the safety and tolerability of ISIS 113715
To evaluate the pharmacokinetic profile of ISIS 113715
To evaluate the pharmacologic activity of ISIS 113715

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimate)

May 26, 2006

Study Record Updates

Last Update Posted (Estimate)

February 6, 2008

Last Update Submitted That Met QC Criteria

February 4, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 113715-CS7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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