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ISIS-GCGRRx- Dose Level 1

Phase 2

Type 2 Diabetes | Small molecule | Metabolic |Ionis Pharmaceuticals, Inc.|Last Updated: Jun 25, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

ISIS-GCGRRx- Dose Level 1 · 2 trials · 2 indications

Phase 2 2
NCT02583919Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 DiabetesType 2 Diabetes
COMPLETED79 Analytics
NCT01885260Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 DiabetesType 2 Diabetes Mellitus
COMPLETED77 Analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Patients With Type 2 Diabetes
Type 2 DiabetesUnlock trial analytics
PHASE2COMPLETED
Safety, Tolerability and Efficacy of ISIS-GCGRRx in Type 2 Diabetes
Type 2 Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in HbA1C
Week 27 and subsequent timepoints

Change from Baseline

The effect of ISIS-GCGRRx on serum fructosamine
14 Weeks

Change from Baseline to Week 14

Secondary Endpoints

Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort
50 weeks
The safety of ISIS-GCGRRx
25 Weeks
The tolerability of ISIS-GCGRRx
25 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ISIS-GCGRRx - Dose Level 1EXPERIMENTALISIS-GCGRRx - Dose Level 1
ISIS-GCGRRx - Dose Level 2EXPERIMENTALISIS-GCGRRx - Dose Level 2
PlaceboPLACEBO_COMPARATORPlacebo
ISIS-GCGRRx Dose Level 1EXPERIMENTALISIS-GCGRRx Dose Level 1
ISIS-GCGRRx Dose Level 2EXPERIMENTALISIS-GCGRRx Dose Level 2

Interventions

NameTypeDescription
ISIS-GCGRRx- Dose Level 1DRUGonce weekly dosing for 26 weeks
ISIS-GCGRRx- Dose Level 2DRUGonce weekly dosing for 26 weeks
PlaceboDRUGonce weekly dosing for 26 weeks
ISIS-GCGRRx - Dose Level 1DRUG3 doses on alternate days during the first week and then once weekly for 12 weeks
ISIS-GCGRRx - Dose Level 2DRUG3 doses on alternate days during the first week and then once weekly for 12 weeks
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites19

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 medica...

Countries:United StatesSouth Africa
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Frequently asked questions about ISIS-GCGRRx- Dose Level 1

What is ISIS-GCGRRx-Dose Level 1 used for?

ISIS-GCGRRx-Dose Level 1 is an investigational small molecule being developed for the treatment of Type 2 Diabetes Mellitus and Type 2 Diabetes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes ISIS-GCGRRx-Dose Level 1?

ISIS-GCGRRx-Dose Level 1 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is ISIS-GCGRRx-Dose Level 1 in?

ISIS-GCGRRx-Dose Level 1 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The drug is being studied for its potential use in treating Type 2 Diabetes.

What clinical trials is ISIS-GCGRRx-Dose Level 1 in?

ISIS-GCGRRx-Dose Level 1 has been studied in two completed Phase 2 clinical trials. The first trial, NCT01885260, enrolled 77 participants with Type 2 Diabetes Mellitus in the United States and South Africa. The second trial, NCT02583919, enrolled 79 participants with Type 2 Diabetes in the United States.

Is ISIS-GCGRRx-Dose Level 1 the same as ISIS-GCGRRx?

ISIS-GCGRRx-Dose Level 1 is a specific dose level of the investigational drug ISIS-GCGRRx. The clinical trials NCT01885260 and NCT02583919 evaluated the safety, tolerability, and efficacy of ISIS-GCGRRx, with Dose Level 1 being one of the doses studied.