Clinical trial NCT01968265: Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes
Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks 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: 2013-10-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx 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
* Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening
* History of diabetic ketoacidosis
* Current or previous diagnosis of Gilbert's disease
* 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-GCCRRx on serum fructosamine
timeFrame: 7 Weeks
Secondary outcomes:
measure: The safety of ISIS-GCCRRx
timeFrame: 18 Weeks
measure: The tolerability of ISIS-GCCRRx
timeFrame: 18 Weeks
Other outcomes:
Locations:
city: Red Deer
country: Canada
facility: Isis Investigative Site
state: Alberta
city: Penticton
country: Canada
facility: Isis Investigative Site
state: British Columbia
city: Cornwall
country: Canada
facility: Isis Investigative Site
state: Ontario
city: Courtice
country: Canada
facility: Isis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Isis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Isis Investigative Site
state: Quebec
city: Cluj Napoca
country: Romania
facility: Isis Investigative Site
state: Cluj
city: Bucharest
country: Romania
facility: Isis Investigative Site
city: Bucharest
country: Romania
facility: Isis Investigative Site
city: Bucharest
country: Romania
facility: Isis Investigative site
city: Bloemfontein
country: South Africa
facility: Isis Investigative Site
state: Free State
city: Benoni
country: South Africa
facility: Isis Investigative Site
state: Gauteng
city: Soweto
country: South Africa
facility: Isis Investigative Site
state: Gauteng
city: Somerset West
country: South Africa
facility: Isis Investigative Site
state: Western Cape
Study officials:
References: