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

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ClinicalTrials.gov Identifier: NCT02824003
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: ISIS-GCGRRx Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 15, 2016
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ISIS-GCGRRx
ISIS-GCGRRx once weekly dosing for 13 weeks
Drug: ISIS-GCGRRx
once weekly dosing for 13 weeks
Other Name: ISIS 449884

Placebo Comparator: Placebo
once weekly dosing for 13 weeks
Drug: Placebo
once weekly dosing for 13 weeks




Primary Outcome Measures :
  1. Change in fasting hepatic glycogen content [ Time Frame: Week 14 ]
    Change from Baseline

  2. Change in fasting hepatic lipid content [ Time Frame: Week 14 ]
    Change from Baseline


Secondary Outcome Measures :
  1. Safety and Tolerability will be assessed by determining the incidence, severity, dose relationship of adverse effects, and changes in laboratory evaluations [ Time Frame: 38 weeks ]
    Safety results in patients dosed with ISIS 449884 will be compared with those from patients dosed with placebo



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824003


Locations
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Austria
Ionis Investigator Site
Vienna, Austria, A-1130
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Investigators
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Study Director: Sanjay Bhanot Ionis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02824003    
Other Study ID Numbers: ISIS 449884-CS3
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases