Safety, Tolerability and Efficacy of ISIS-GCCRRx 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-GCCRRx in combination with metformin versus placebo + metformin

Official Title
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A Randomized, Double Blind, Placebo-Controlled, Phase 2 Study to Assess the Safety, Tolerability and Efficacy of ISIS 426115 (an Antisense Glucocorticoid Receptor Antagonist) Administered Subcutaneously Once Weekly for 6 Weeks 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-GCCRRx
* 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 Use of medications that may affect plasma glucose levels (including systemic glucocorticoids), systemic steroids, corticosteroids, antiglucocorticoid therapies including mifepristone and ketoconazole (topical cream and systemic), immunosuppressive medications, somatostatin analogues or ACTH therapy within 3 months of screening History of diabetic ketoacidosis Current or previous diagnosis of Gilbert's disease 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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin<br>|
| Active Comparator: ISIS-GCCRRx<br> | Drug: ISIS-GCCRRx<br>* 3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of ISIS-GCCRRx on serum fructosamine | Change from Baseline to Week 7 | 7 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of ISIS-GCCRRx | By determining the incidence, severity, adverse effects, and changes in laboratory evaluations | 18 Weeks | 
| The tolerability of ISIS-GCCRRx | By determining the incidence, severity, adverse effects, and changes in laboratory evaluations | 18 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