Clinical trial NCT00330330: Safety, Tolerability, and Activity of ISIS 113715 in People With Type 2 Diabetes Mellitus Who Have Not Received Prior 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Fasting plasma glucose
HbA1c
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To evaluate the safety and tolerability of ISIS 113715
measure: To evaluate the pharmacokinetic profile of ISIS 113715
measure: To evaluate the pharmacologic activity of ISIS 113715
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Osrodek Internistyczno Diabetologiczny
city: Radom
country: Poland
facility: Prywatna Praktyka Lekarska
city: Wolomin
country: Poland
facility: Oddzial Chorob Wewnetrznych ze Stacja Dializ Szpital w Wolominie
city: Moscow
country: Russian Federation
facility: Chair of Endocrinology and Diabetology of the Faculty of Advenced Training for Physicians
city: Moscow
country: Russian Federation
facility: Endocrinology Scientific Centre of RAMS
city: Moscow
country: Russian Federation
facility: Medical Institution "Polyclinic OAOA Gazprom"
city: Moscow
country: Russian Federation
facility: Close Corporation "MEDSI"
city: Moscow
country: Russian Federation
facility: Chair of Endocrinology and Diabetology Central Clinical Hospital of the Ministry of Communications of RF
city: Moscow
country: Russian Federation
facility: Moscow Regional Scientific-Research Clinical Institute named after I.F. Vladimirsky
city: St. Petersburg
country: Russian Federation
facility: Clinic of Therapy of Postgraduate Education named after N.S. Molchanov
Study officials:
affiliation: Ionis Pharmaceuticals, Inc.
name: Mark K Wedel, MD, JD, FACP
role: STUDY_DIRECTOR
References:
citation: 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.