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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885260
• Other study ID #: ISIS 449884-CS2
• Status: Completed
• Phase: Phase 2
• First received: June 13, 2013
• Last updated: June 30, 2016
• Start date: July 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2016
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSouth 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-GCGRRx in combination with metformin versus placebo + metformin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• 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

• 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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ISIS-GCGRRx - Dose Level 1
3 doses on alternate days during the first week and then once weekly for 12 weeks
• ISIS-GCGRRx - Dose Level 2
3 doses on alternate days during the first week and then once weekly for 12 weeks
• Placebo
3 doses on alternate days during the first week and then once weekly for 12 weeks

Locations

Country	Name	City	State
South Africa	Isis Investigational Site	Cape Town	Western Cape
South Africa	Isis Investigational Site	Durban	KwaZulu-Natal
South Africa	Isis Investigational Site	Lenasia South	Gauteng
South Africa	Isis Investigational Site	Parow, Cape Town	Western Cape
South Africa	Isis Investigational Site	Soweto	Gauteng
South Africa	Isis Investigational Site	Western Cape
United States	Isis Investigational Site	Anaheim	California
United States	Isis Investigational Site	Birmingham	Alabama
United States	Isis Investigational Site	Chino	California
United States	Isis Investigational Site	Cincinnati	Ohio
United States	Isis Investigational Site	Corpus Christi	Texas
United States	Isis Investigational Site	Deland	Florida
United States	Isis Investigational Site	Eugene	Oregon
United States	Isis Investigational Site	Ft. Lauderdale	Florida
United States	Isis Investigational Site	Katy	Texas
United States	Isis Investigational Site	Las Vegas	Nevada
United States	Isis Investigational Site	Los Angeles	California
United States	Isis Investigational Site	Marietta	Georgia
United States	Isis Investigational Site	Miami	Florida
United States	Isis Investigational Site	Muscle Shoals	Alabama
United States	Isis Investigational Site	Oklahoma City	Oklahoma
United States	Isis Investigational Site	Renton	Washington
United States	Isis Investigational Site	Salt Lake City	Utah
United States	Isis Investigational Site	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of ISIS-GCGRRx on serum fructosamine	Change from Baseline to Week 14	14 Weeks	No
Secondary	The safety of ISIS-GCGRRx	By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations	25 Weeks	Yes
Secondary	The tolerability of ISIS-GCGRRx	By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations	25 Weeks	No