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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ISIS-GCCRRx
Placebo
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, T2DM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site
  • Isis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

ISIS-GCCRRx

Arm Description

Outcomes

Primary Outcome Measures

The effect of ISIS-GCCRRx on serum fructosamine
Change from Baseline to Week 7

Secondary Outcome Measures

The safety of ISIS-GCCRRx
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
The tolerability of ISIS-GCCRRx
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations

Full Information

First Posted
October 18, 2013
Last Updated
May 11, 2015
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01968265
Brief Title
Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes
Official Title
A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, T2DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
ISIS-GCCRRx
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ISIS-GCCRRx
Intervention Description
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
Primary Outcome Measure Information:
Title
The effect of ISIS-GCCRRx on serum fructosamine
Description
Change from Baseline to Week 7
Time Frame
7 Weeks
Secondary Outcome Measure Information:
Title
The safety of ISIS-GCCRRx
Description
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
Time Frame
18 Weeks
Title
The tolerability of ISIS-GCCRRx
Description
By determining the incidence, severity, adverse effects, and changes in laboratory evaluations
Time Frame
18 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Isis Investigative Site
City
Red Deer
State/Province
Alberta
Country
Canada
Facility Name
Isis Investigative Site
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
Isis Investigative Site
City
Cornwall
State/Province
Ontario
Country
Canada
Facility Name
Isis Investigative Site
City
Courtice
State/Province
Ontario
Country
Canada
Facility Name
Isis Investigative Site
City
Sudbury
State/Province
Ontario
Country
Canada
Facility Name
Isis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2R1V6
Country
Canada
Facility Name
Isis Investigative Site
City
Cluj Napoca
State/Province
Cluj
ZIP/Postal Code
400349
Country
Romania
Facility Name
Isis Investigative Site
City
Bucharest
ZIP/Postal Code
010507
Country
Romania
Facility Name
Isis Investigative Site
City
Bucharest
ZIP/Postal Code
011794
Country
Romania
Facility Name
Isis Investigative site
City
Bucharest
ZIP/Postal Code
022441
Country
Romania
Facility Name
Isis Investigative Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Isis Investigative Site
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1501
Country
South Africa
Facility Name
Isis Investigative Site
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Isis Investigative Site
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa

12. IPD Sharing Statement

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

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