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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:
ClinicalTrials.gov Identifier:
NCT00330330
First Posted: May 26, 2006
Last Update Posted: February 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ionis Pharmaceuticals, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double
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 Ionis Pharmaceuticals, Inc.:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians
Moscow, Russian Federation, 109125
Endocrinology Scientific Centre of RAMS
Moscow, Russian Federation, 117036
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
Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky
Moscow, Russian Federation, 129110
Clinic of Therapy of Postgraduate Education named after N.S. Molchanov
St. Petersburg, Russian Federation, 198013
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Investigators
Study Director: Mark K Wedel, MD, JD, FACP Ionis Pharmaceuticals, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00330330     History of Changes
Other Study ID Numbers: ISIS 113715-CS7
First Submitted: May 24, 2006
First Posted: May 26, 2006
Last Update Posted: February 6, 2008
Last Verified: February 2008

Keywords provided by Ionis Pharmaceuticals, Inc.:
Fasting plasma glucose
HbA1c

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