Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
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
1 other identifier
interventional
77
2 countries
24
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
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-mellitus
Started Jul 2013
Typical duration for phase_2 type-2-diabetes-mellitus
24 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
First Submitted
Initial submission to the registry
June 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedJuly 4, 2016
June 1, 2016
10 months
June 13, 2013
June 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of ISIS-GCGRRx on serum fructosamine
Change from Baseline to Week 14
14 Weeks
Secondary Outcomes (2)
The safety of ISIS-GCGRRx
25 Weeks
The tolerability of ISIS-GCGRRx
25 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
3 doses on alternate days during the first week and then once weekly for 12 weeks
3 doses on alternate days during the first week and then once weekly for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Isis Investigational Site
Birmingham, Alabama, 35216, United States
Isis Investigational Site
Muscle Shoals, Alabama, 35662, United States
Isis Investigational Site
Anaheim, California, 92801, United States
Isis Investigational Site
Chino, California, 91710, United States
Isis Investigational Site
Los Angeles, California, 90057, United States
Isis Investigational Site
DeLand, Florida, 32720, United States
Isis Investigational Site
Fort Lauderdale, Florida, 33306, United States
Isis Investigational Site
Miami, Florida, 33143, United States
Isis Investigational Site
Marietta, Georgia, 30066, United States
Isis Investigational Site
Las Vegas, Nevada, 89101, United States
Isis Investigational Site
Cincinnati, Ohio, 45245, United States
Isis Investigational Site
Oklahoma City, Oklahoma, 73103, United States
Isis Investigational Site
Eugene, Oregon, 97404, United States
Isis Investigational Site
Corpus Christi, Texas, 78404, United States
Isis Investigational Site
Katy, Texas, 77450, United States
Isis Investigational Site
Salt Lake City, Utah, 84107, United States
Isis Investigational Site
Renton, Washington, 98057, United States
Isis Investigational Site
Spokane, Washington, 99202, United States
Isis Investigational Site
Lenasia South, Gauteng, 1829, South Africa
Isis Investigational Site
Soweto, Gauteng, 1818, South Africa
Isis Investigational Site
Durban, KwaZulu-Natal, 4091, South Africa
Isis Investigational Site
Cape Town, Western Cape, 7700, South Africa
Isis Investigational Site
Parow, Cape Town, Western Cape, 7500, South Africa
Isis Investigational Site
Western Cape, Western Cape, 7130, South Africa
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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2013
First Posted
June 24, 2013
Study Start
July 1, 2013
Primary Completion
May 1, 2014
Study Completion
November 1, 2014
Last Updated
July 4, 2016
Record last verified: 2016-06