Study to Evaluate the Effect of ISIS GCGRRx on Hepatic Lipid and Glycogen Content in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Double Blind, Randomized, Placebo-Controlled, Phase 2A Mechanistic Study to Evaluate the Effect of ISIS 449884 (ISIS-GCGRRx) on Hepatic Lipid and Glycogen Content in Patients With Type 2 Diabetes Being Treated With Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02824003
• Other study ID #: ISIS 449884-CS3
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: May 22, 2017

Study information

• Verified date: May 2018
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of ISIS 449884 (ISIS-GCGRRX) on Hepatic Lipid and Glycogen Content in patients with Type 2 Diabetes being treated with Metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 22, 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 < 36.0 kg/m2

• HbA1c = 7.5% and = 10.5%

• Type 2 Diabetes Mellitus and on stable dose of Metformin. Patients must have been on a stable dose of oral metformin (at least 1000 mg/day) for a minimum of 3 months prior to screening evaluation and will be required to continue their stable dose of metformin throughout the study. Patients on a stable dose of metformin plus a sulfonylurea (SU) or metformin plus a dipeptidyl peptidase-IV (DPPIV) inhibitor for a minimum of 3 months prior to Screening evaluation may be allowed

• 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

• History of liver transplantation 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, SU or DPPIV 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 -

Related Conditions & MeSH terms

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

Intervention

Drug:
• ISIS-GCGRRx
once weekly dosing for 13 weeks
• Placebo
once weekly dosing for 13 weeks

Locations

Country	Name	City	State
Austria	Ionis Investigator Site	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in fasting hepatic glycogen content	Change from Baseline	Week 14
Primary	Change in fasting hepatic lipid content	Change from Baseline	Week 14
Secondary	Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations	Safety results in patients dosed with ISIS 449884 will be compared with those from patients dosed with placebo	38 weeks