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OpenTrials
Completed

NCT Number: NCT02583919

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ionis Investigational Site, Greenbrae, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISIS-GCGRRx- Dose Level 1

Drug

once weekly dosing for 26 weeks

Other names: Isis 449884

ISIS-GCGRRx- Dose Level 2

Drug

once weekly dosing for 26 weeks

Other names: Isis 449884

Placebo

Drug

once weekly dosing for 26 weeks

Primary outcomes

  1. Change in HbA1C

    Time frame: Week 27 and subsequent timepoints

    Change from Baseline

Secondary outcomes

  1. Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort

    Time frame: 50 weeks

    Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 22, 2015
Registry last updated
Jun 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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