Clinical trial NCT01885260: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
T2DM
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 77
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 + metformin


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

Primary outcomes:
measure: The effect of ISIS-GCGRRx on serum fructosamine
timeFrame: 14 Weeks
Secondary outcomes:
measure: The safety of ISIS-GCGRRx
timeFrame: 25 Weeks
measure: The tolerability of ISIS-GCGRRx
timeFrame: 25 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Isis Investigational Site
state: Alabama
city: Muscle Shoals
country: United States
facility: Isis Investigational Site
state: Alabama
city: Anaheim
country: United States
facility: Isis Investigational Site
state: California
city: Chino
country: United States
facility: Isis Investigational Site
state: California
city: Los Angeles
country: United States
facility: Isis Investigational Site
state: California
city: Deland
country: United States
facility: Isis Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Isis Investigational Site
state: Florida
city: Miami
country: United States
facility: Isis Investigational Site
state: Florida
city: Marietta
country: United States
facility: Isis Investigational Site
state: Georgia
city: Las Vegas
country: United States
facility: Isis Investigational Site
state: Nevada
city: Cincinnati
country: United States
facility: Isis Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Isis Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Isis Investigational Site
state: Oregon
city: Corpus Christi
country: United States
facility: Isis Investigational Site
state: Texas
city: Katy
country: United States
facility: Isis Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Isis Investigational Site
state: Utah
city: Renton
country: United States
facility: Isis Investigational Site
state: Washington
city: Spokane
country: United States
facility: Isis Investigational Site
state: Washington
city: Lenasia South
country: South Africa
facility: Isis Investigational Site
state: Gauteng
city: Soweto
country: South Africa
facility: Isis Investigational Site
state: Gauteng
city: Durban
country: South Africa
facility: Isis Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Isis Investigational Site
state: Western Cape
city: Parow, Cape Town
country: South Africa
facility: Isis Investigational Site
state: Western Cape
city: Western Cape
country: South Africa
facility: Isis Investigational Site
Study officials:
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.