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NCT02583919 Clinical Trial

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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02583919
Other study ID # ISIS 449884-CS4
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2015
Est. completion date May 11, 2017

Study information
Verified date June 2018
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
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

Recruitment information / eligibility
Status Completed
Enrollment 79
Est. completion date May 11, 2017
Est. primary completion date December 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ISIS-GCGRRx- Dose Level 1
once weekly dosing for 26 weeks
• ISIS-GCGRRx- Dose Level 2
once weekly dosing for 26 weeks
• Placebo
once weekly dosing for 26 weeks

Locations
Country Name City State
United States Ionis Investigational Site Cincinnati Ohio
United States Ionis Investigational Site Cincinnati Ohio
United States Ionis Investigational Site Eugene Oregon
United States Ionis Investigational Site Greenbrae California
United States Ionis Investigational Site Greensboro North Carolina
United States Ionis Investigational Site Houston Texas
United States Ionis Investigational Site Houston Texas
United States Ionis Investigational Site Huntington Park California
United States Ionis Investigational Site Katy Texas
United States Ionis Investigational Site La Mesa California
United States Ionis Investigational Site Los Angeles California
United States Ionis Investigational Site Marietta Georgia
United States Ionis Investigational Site Morehead City North Carolina
United States Ionis Investigational Site New York New York
United States Ionis Investigational Site Olympia Washington
United States Ionis Investigational Site Oxon Hill Maryland
United States Ionis Investigational Site Port Orange Florida
United States Ionis Investigational Site Spartanburg South Carolina
United States Isis Investigational Site Spring Valley California

Sponsors (1)
Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1C Change from Baseline Week 27 and subsequent timepoints
Secondary Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo 50 weeks
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