Safety, Tolerability and Activity Study of Multiple Doses of ISIS-SGLT2Rx in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

Brief Summary

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The primary purpose of this trial is to assess the safety and tolerability of ISIS-SGLT2Rx when given at increasing single doses and to assess the safety and tolerability of the same doses when given multiple times.

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Detailed Description

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To evaluate the safety and tolerability of a single subcutaneous injection of ISIS-SGLT2Rx administered at four increasing dose levels (50, 100, 200, 400 mg) and to evaluate the safety and tolerability of multiple doses of ISIS 388626 administered subcutaneously of either 6 or 13 weeks.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

50 mg ISIS 388626 vs Placebo, s.c. injection

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

B

100 mg ISIS 388626 vs Placebo, s.c. injection

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

C

200 mg ISIS 388626 vs Placebo, s.c. injection

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

D

400 mg ISIS 388626 vs Placebo, s.c. injection

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

AA

50 mg ISIS 388626, 3x over 1 week s.c. injection, weekly s.c. injection for 5 weeks vs Placebo

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

BB

100 mg ISIS 388626, 3x over 1 week s.c. injection, weekly s.c. injection for 5 weeks vs Placebo

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

AAA

50 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

BBB

100 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

CCC

200 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

FFF

50 mg ISIS 388626, weekly s.c. injection for 13 weeks vs Placebo

Group Type EXPERIMENTAL

ISIS 388626

Intervention Type DRUG

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

Interventions

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ISIS 388626

4 arms of single dose s.c. injections: A 50 mg, B 100 mg, C 200 mg, D 400 mg, 2 arms of multi-dose: 3 s.c. injections over 1 week followed by 5 weekly s.c. injections: AA 50 mg, BB 100 mg 3 arms of multi-dose 13 weekly s.c. injections: AAA 50 mg, BBB 100 mg, CCC 200 mg, FFF 50 mg

Placebo: 0.9% sterile saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 65 years
* Male or female gender although females must be post-menopausal or surgically sterile (hysterectomy, oophorectomy or tubal ligation)
* Give written informed consent to participate in the study and availability for all study requirements
* Fasting plasma glucose \</= the upper limit of the laboratory's reference range (ULN)
* HbA1c \</= ULN
* BMI \< 30 kg/m²
* Agree to maintain steady hydration throughout study participation and agree not to fluid restrict

Exclusion Criteria

* Pregnant women, nursing mothers or women of childbearing potential
* Clinically significant abnormalities in medical history or physical examination
* Clinically significant abnormalities in laboratory examination (including ALT \> ULN, AST \> ULN, bilirubin \> ULN, creatinine \> ULN, urine protein positive by urine dipstick, platelets \< lower limit of normal and any other clinically significant laboratory findings)
* Estimated GFR \< 60 mL/min per 1.73m²
* History of clinically significant abnormalities in coagulation parameters
* Positive test result for HIV, hepatitis B virus, and/or hepatitis C virus
* Active infection requiring antiviral or antimicrobial therapy
* Subjects on chronic or acute prescription medication may be permitted after discussion with the Isis Medical Monitor
* Malignancy (with the exception of basal or squamous cell carcinoma of the skin if adequately treated and no recurrence for \> 1 year)
* Any other concurrent condition which, in the opinion of the Investigator, would preclude participation in this study or interfere with compliance
* Past and present history of alcohol or drug abuse (defined as \> 3 units daily)
* Undergoing or have undergone treatment with another investigational drug, biologic agent or device within 90 days prior to Screening
* Blood donation within three months of Screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes