Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
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
1 other identifier
interventional
79
1 country
19
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 type-2-diabetes
Started Sep 2015
Typical duration for phase_2 type-2-diabetes
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2017
CompletedJune 25, 2018
June 1, 2018
1.3 years
October 12, 2015
June 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in HbA1C
Change from Baseline
Week 27 and subsequent timepoints
Secondary Outcomes (1)
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
50 weeks
Study Arms (3)
ISIS-GCGRRx - Dose Level 1
EXPERIMENTALISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 2
EXPERIMENTALISIS-GCGRRx - Dose Level 2
Placebo
PLACEBO COMPARATORPlacebo
Interventions
once weekly dosing for 26 weeks
once weekly dosing for 26 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Ionis Investigational Site
Greenbrae, California, 94904, United States
Ionis Investigational Site
Huntington Park, California, 90255, United States
Ionis Investigational Site
La Mesa, California, 91942, United States
Ionis Investigational Site
Los Angeles, California, 90057, United States
Isis Investigational Site
Spring Valley, California, 91978, United States
Ionis Investigational Site
Port Orange, Florida, 32127, United States
Ionis Investigational Site
Marietta, Georgia, 30060, United States
Ionis Investigational Site
Oxon Hill, Maryland, 20745, United States
Ionis Investigational Site
New York, New York, 10016, United States
Ionis Investigational Site
Greensboro, North Carolina, 27410, United States
Ionis Investigational Site
Morehead City, North Carolina, 28557, United States
Ionis Investigational Site
Cincinnati, Ohio, 45219, United States
Ionis Investigational Site
Cincinnati, Ohio, 45245, United States
Ionis Investigational Site
Eugene, Oregon, 97404, United States
Ionis Investigational Site
Spartanburg, South Carolina, 29303, United States
Ionis Investigational Site
Houston, Texas, 77036, United States
Ionis Investigational Site
Houston, Texas, 77074, United States
Ionis Investigational Site
Katy, Texas, 77450, United States
Ionis Investigational Site
Olympia, Washington, 98502, United States
Related Publications (1)
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.
PMID: 30765435DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sanjay Bhanot
Ionis Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 22, 2015
Study Start
September 1, 2015
Primary Completion
December 15, 2016
Study Completion
May 11, 2017
Last Updated
June 25, 2018
Record last verified: 2018-06