Safety, Tolerability and Efficacy of ISIS-GCCRRx in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01968265
• Other study ID #: ISIS 426115-CS2
• Secondary ID: 2013-002172-40
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2013
• Last updated: May 11, 2015
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaRomania: Ministry of Public HealthSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of ISIS-GCCRRx in combination with metformin versus placebo + metformin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• ISIS-GCCRRx
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
• Placebo
3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin

Locations

Country	Name	City	State
Canada	Isis Investigative Site	Cornwall	Ontario
Canada	Isis Investigative Site	Courtice	Ontario
Canada	Isis Investigative Site	Montreal	Quebec
Canada	Isis Investigative Site	Penticton	British Columbia
Canada	Isis Investigative Site	Red Deer	Alberta
Canada	Isis Investigative Site	Sudbury	Ontario
Romania	Isis Investigative Site	Bucharest
Romania	Isis Investigative Site	Bucharest
Romania	Isis Investigative site	Bucharest
Romania	Isis Investigative Site	Cluj Napoca	Cluj
South Africa	Isis Investigative Site	Benoni	Gauteng
South Africa	Isis Investigative Site	Bloemfontein	Free State
South Africa	Isis Investigative Site	Somerset West	Western Cape
South Africa	Isis Investigative Site	Soweto	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Canada,  Romania,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of ISIS-GCCRRx on serum fructosamine	Change from Baseline to Week 7	7 Weeks	No
Secondary	The safety of ISIS-GCCRRx	By determining the incidence, severity, adverse effects, and changes in laboratory evaluations	18 Weeks	Yes
Secondary	The tolerability of ISIS-GCCRRx	By determining the incidence, severity, adverse effects, and changes in laboratory evaluations	18 Weeks	No