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

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

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: ISIS-GCGRRx- Dose Level 1
* Drug: ISIS-GCGRRx- Dose Level 2
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISIS-GCGRRx - Dose Level 1<br>ISIS-GCGRRx - Dose Level 1 | Drug: ISIS-GCGRRx- Dose Level 1<br>* once weekly dosing for 26 weeks<br>* Other names: Isis 449884;|
| Experimental: ISIS-GCGRRx - Dose Level 2<br>ISIS-GCGRRx - Dose Level 2 | Drug: ISIS-GCGRRx- Dose Level 2<br>* once weekly dosing for 26 weeks<br>* Other names: Isis 449884;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* once weekly dosing for 26 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1C | Change from Baseline | Week 27 and subsequent timepoints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability will be assessed by determining the incidence, severity, dose-relationship adverse-effects, and changes in laboratory evaluations within each dose cohort | Safety results in patients dosed with Isis 449884 will be compared with those from patients dosed with placebo | 50 weeks |