Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type... | NCT01968265

Studies
Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes

NCT01968265

Sponsor

Ionis Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

May 13, 2015Estimated

Enrollment

38Actual

Phase

Phase 2

Conditions

Type 2 Diabetes Mellitus

Interventions

ISIS-GCCRRx
Placebo

Countries

Canada
Romania
South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-002172-40	EudraCT Number

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jan 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Oct 18, 2013

First Submission Date that Met QC Criteria

Oct 22, 2013

First Posted Date

Oct 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2015

Last Update Posted Date

May 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
ISIS-GCCRRx	Active Comparator		Drug: ISIS-GCCRRx

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ISIS-GCCRRx	Drug	3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin	ISIS-GCCRRx

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The effect of ISIS-GCCRRx on serum fructosamine	Change from Baseline to Week 7	7 Weeks

Secondary Outcomes

Measure	Description	Time Frame
The safety of ISIS-GCCRRx	By determining the incidence, severity, adverse effects, and changes in laboratory evaluations	18 Weeks
The tolerability of ISIS-GCCRRx	By determining the incidence, severity, adverse effects, and changes in laboratory evaluations

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age 18 to 75
BMI greater than or equal to 25
HbA1c greater than or equal to 7.5% and less than or equal to 10.5%
Type 2 Diabetes Mellitus and on stable dose of oral metformin
Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

Clinically significant abnormalities in medical history or physical exam
Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
History of renal transplantation or renal dialysis
History of liver disease
History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
Use of oral anti-diabetic medication other than metformin within 3 months of screening
Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
History of diabetic ketoacidosis
Current or previous diagnosis of Gilbert's disease
Any other significant illness or condition that may interfere with the patient participating or completing the study
Inability or unwillingness to comply with protocol or study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Isis Investigative Site		Red Deer	Alberta		Canada
Isis Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided