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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 2
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
  • History of diabetic ketoacidosis
  • 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 Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site
  • Isis Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

ISIS-GCGRRx Dose Level 1

ISIS-GCGRRx Dose Level 2

Placebo

Arm Description

ISIS-GCGRRx Dose Level 1

ISIS-GCGRRx Dose Level 2

Placebo

Outcomes

Primary Outcome Measures

The effect of ISIS-GCGRRx on serum fructosamine
Change from Baseline to Week 14

Secondary Outcome Measures

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

Full Information

First Posted
June 13, 2013
Last Updated
June 30, 2016
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01885260
Brief Title
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
Official Title
A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (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-GCGRRx 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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISIS-GCGRRx Dose Level 1
Arm Type
Experimental
Arm Description
ISIS-GCGRRx Dose Level 1
Arm Title
ISIS-GCGRRx Dose Level 2
Arm Type
Experimental
Arm Description
ISIS-GCGRRx Dose Level 2
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
ISIS-GCGRRx - Dose Level 1
Other Intervention Name(s)
Isis 449884
Intervention Description
3 doses on alternate days during the first week and then once weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ISIS-GCGRRx - Dose Level 2
Other Intervention Name(s)
Isis 449884
Intervention Description
3 doses on alternate days during the first week and then once weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 doses on alternate days during the first week and then once weekly for 12 weeks
Primary Outcome Measure Information:
Title
The effect of ISIS-GCGRRx on serum fructosamine
Description
Change from Baseline to Week 14
Time Frame
14 Weeks
Secondary Outcome Measure Information:
Title
The safety of ISIS-GCGRRx
Description
By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
Time Frame
25 Weeks
Title
The tolerability of ISIS-GCGRRx
Description
By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations
Time Frame
25 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 History of diabetic ketoacidosis 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 Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Isis Investigational Site
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Isis Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Isis Investigational Site
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Isis Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Isis Investigational Site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Isis Investigational Site
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Isis Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Isis Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Isis Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Isis Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Isis Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Isis Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Isis Investigational Site
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Isis Investigational Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Isis Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Isis Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Isis Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Isis Investigational Site
City
Lenasia South
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Facility Name
Isis Investigational Site
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
1818
Country
South Africa
Facility Name
Isis Investigational Site
City
Durban
State/Province
KwaZulu-Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Isis Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Isis Investigational Site
City
Parow, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Isis Investigational Site
City
Western Cape
ZIP/Postal Code
7130
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
30765435
Citation
Morgan ES, Tai LJ, Pham NC, Overman JK, Watts LM, Smith A, Jung SW, Gajdosik M, Krssak M, Krebs M, Geary RS, Baker BF, Bhanot S. Antisense Inhibition of Glucagon Receptor by IONIS-GCGRRx Improves Type 2 Diabetes Without Increase in Hepatic Glycogen Content in Patients With Type 2 Diabetes on Stable Metformin Therapy. Diabetes Care. 2019 Apr;42(4):585-593. doi: 10.2337/dc18-1343. Epub 2019 Feb 14.
Results Reference
derived

Learn more about this trial

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

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