FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02583919
Enrollment
79
Registered
2015-10-22
Start date
2015-09-30
Completion date
2017-05-11
Last updated
2018-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

Interventions

DRUGISIS-GCGRRx- Dose Level 1

once weekly dosing for 26 weeks

DRUGISIS-GCGRRx- Dose Level 2

once weekly dosing for 26 weeks

DRUGPlacebo

once weekly dosing for 26 weeks

Sponsors

Ionis Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in HbA1CWeek 27 and subsequent timepointsChange from Baseline

Secondary

MeasureTime frameDescription
Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort50 weeksSafety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026