Safety, Tolerability and Efficacy of ISIS-GCGRRx in 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 + metformin

Official Title
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A Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 449884 Administered Once Weekly to Patients With Type 2 Diabetes Mellitus Being Treated With Metformin

Conditions
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Type 2 Diabetes Mellitus

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 greater than or equal to 25 HbA1c greater than or equal to 7.5% and less than or equal to 10.5% Type 2 Diabetes Mellitus and on stable dose of oral metformin 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 hormone results History of renal transplantation or renal dialysis History of liver disease History of greater than 3 episodes of severe hypoglycemia within 6 months of screening Use of oral anti-diabetic medication 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: Triple


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>* 3 doses on alternate days during the first week and then once weekly for 12 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>* 3 doses on alternate days during the first week and then once weekly for 12 weeks<br>* Other names: Isis 449884;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 3 doses on alternate days during the first week and then once weekly for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of ISIS-GCGRRx on serum fructosamine | Change from Baseline to Week 14 | 14 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of ISIS-GCGRRx | By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations | 25 Weeks | 
| The tolerability of ISIS-GCGRRx | By determining the incidence, severity, dose-relationship adverse effects, and changes in laboratory evaluations | 25 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, T2DM