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

This study has been completed.
Sponsor:
Information provided by:
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00330330
First received: May 24, 2006
Last updated: February 4, 2008
Last verified: February 2008
  Purpose

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.


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 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

Resource links provided by NLM:


Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 96
Study Start Date: February 2003
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330330

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

No publications provided

ClinicalTrials.gov Identifier: NCT00330330     History of Changes
Other Study ID Numbers: ISIS 113715-CS7
Study First Received: May 24, 2006
Last Updated: February 4, 2008
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Isis Pharmaceuticals:
Fasting plasma glucose
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014