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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
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

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 ≥ 25.0 kg/m2
  • HbA1c ≥ 8.0% and ≤ 10.5%
  • Type 2 Diabetes Mellitus and on stable dose of Metformin
  • Agree to conduct home-based (fasted) blood glucose testing as directed

Exclusion Criteria:

  • Clinically significant abnormalities in medical history of physical exam
  • Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results
  • History of solid organ transplant or renal dialysis
  • History of liver disease
  • History of greater than 3 episodes of severe hypoglycemia within 6 months of screening
  • Treatment with any other antidiabetic drug(s) 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

  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Isis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis Investigational Site
  • Ionis 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

Change in HbA1C
Change from Baseline

Secondary Outcome Measures

Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo

Full Information

First Posted
October 12, 2015
Last Updated
June 20, 2018
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02583919
Brief Title
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
Official Title
Double Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly for 26 Weeks in Patients With Type 2 Diabetes Being Treated With Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
May 11, 2017 (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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (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
once weekly dosing for 26 weeks
Intervention Type
Drug
Intervention Name(s)
ISIS-GCGRRx- Dose Level 2
Other Intervention Name(s)
Isis 449884
Intervention Description
once weekly dosing for 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once weekly dosing for 26 weeks
Primary Outcome Measure Information:
Title
Change in HbA1C
Description
Change from Baseline
Time Frame
Week 27 and subsequent timepoints
Secondary Outcome Measure Information:
Title
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
Description
Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo
Time Frame
50 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 ≥ 25.0 kg/m2 HbA1c ≥ 8.0% and ≤ 10.5% Type 2 Diabetes Mellitus and on stable dose of Metformin Agree to conduct home-based (fasted) blood glucose testing as directed Exclusion Criteria: Clinically significant abnormalities in medical history of physical exam Show evidence of uncorrected hypothyroidism or hyperthyroidism hormone results History of solid organ transplant or renal dialysis History of liver disease History of greater than 3 episodes of severe hypoglycemia within 6 months of screening Treatment with any other antidiabetic drug(s) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Bhanot
Organizational Affiliation
Ionis Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Ionis Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Ionis Investigational Site
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Ionis Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Ionis Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Isis Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Ionis Investigational Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Ionis Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Ionis Investigational Site
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Ionis Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Ionis Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
Facility Name
Ionis Investigational Site
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Ionis Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ionis Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Ionis Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Ionis Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Ionis Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Ionis Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Ionis Investigational Site
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Ionis Investigational Site
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States

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

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

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