NCT00330330

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2 type-2-diabetes-mellitus

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

February 6, 2008

Status Verified

February 1, 2008

First QC Date

May 24, 2006

Last Update Submit

February 4, 2008

Conditions

Type 2 Diabetes Mellitus

Keywords

Fasting plasma glucoseHbA1c

Outcome Measures

Primary Outcomes (3)

  • 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

Interventions

ISIS 113715DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny

Bialystok, 15-435, Poland

Location

Prywatna Praktyka Lekarska

Radom, 26-600, Poland

Location

Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie

Wołomin, 05-200, Poland

Location

Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians

Moscow, 109125, Russia

Location

Endocrinology Scientific Centre of RAMS

Moscow, 117036, Russia

Location

Medical Institution "Polyclinic OAOA Gazprom"

Moscow, 117420, Russia

Location

Close Corporation "MEDSI"

Moscow, 123056, Russia

Location

Chair of Endocrinology and Diabetology Central Clinical Hospital of the Ministry of Communications of RF

Moscow, 125315, Russia

Location

Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky

Moscow, 129110, Russia

Location

Clinic of Therapy of Postgraduate Education named after N.S. Molchanov

Saint Petersburg, 198013, Russia

Location

Related Publications (1)

  • Burel SA, Machemer T, Baker BF, Kwoh TJ, Paz S, Younis H, Henry SP. Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. Nucleic Acid Ther. 2022 Dec;32(6):457-472. doi: 10.1089/nat.2022.0033. Epub 2022 Aug 17.

    PMID: 35976085DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

ISIS-113715

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mark K Wedel, MD, JD, FACP

    Ionis Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 24, 2006

First Posted

May 26, 2006

Study Start

February 1, 2003

Study Completion

August 1, 2006

Last Updated

February 6, 2008

Record last verified: 2008-02

Locations

PL(3)RU(7)