Clinical trial NCT02583919: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of ISIS-GCGRRx in combination with metformin versus placebo


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

Primary outcomes:
measure: Change in HbA1C
timeFrame: Week 27 and subsequent timepoints
Secondary outcomes:
measure: Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
timeFrame: 50 weeks
Other outcomes:
Locations:
city: Greenbrae
country: United States
facility: Ionis Investigational Site
state: California
city: Huntington Park
country: United States
facility: Ionis Investigational Site
state: California
city: La Mesa
country: United States
facility: Ionis Investigational Site
state: California
city: Los Angeles
country: United States
facility: Ionis Investigational Site
state: California
city: Spring Valley
country: United States
facility: Isis Investigational Site
state: California
city: Port Orange
country: United States
facility: Ionis Investigational Site
state: Florida
city: Marietta
country: United States
facility: Ionis Investigational Site
state: Georgia
city: Oxon Hill
country: United States
facility: Ionis Investigational Site
state: Maryland
city: New York
country: United States
facility: Ionis Investigational Site
state: New York
city: Greensboro
country: United States
facility: Ionis Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Ionis Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Ionis Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Ionis Investigational Site
state: Ohio
city: Eugene
country: United States
facility: Ionis Investigational Site
state: Oregon
city: Spartanburg
country: United States
facility: Ionis Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Ionis Investigational Site
state: Texas
city: Houston
country: United States
facility: Ionis Investigational Site
state: Texas
city: Katy
country: United States
facility: Ionis Investigational Site
state: Texas
city: Olympia
country: United States
facility: Ionis Investigational Site
state: Washington
Study officials:
affiliation: Ionis Pharmaceuticals, Inc.
name: Sanjay Bhanot
role: STUDY_DIRECTOR
References:
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.