Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

Detailed Description
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Patients sub-optimally controlled on basal insulin (with/without other antihyperglycemic agents (AHAs)) will be randomized 1:1 to either Finesse or pen to initiate bolus insulin dosing and followed for a 44-week intervention period. Patients will have both basal and bolus doses of insulin adjusted throughout the trial, as is clinically indicated, based on an easy to follow insulin dosing algorithm. After the final endpoint evaluation at week 44, patients will crossover to the alternate bolus insulin delivery device for 4 weeks and complete a patient preference survey at week 48.

Official Title
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Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Bolus Insulin Patch (Calibra Finesse)
* Device: Insulin Pen (Novo-Nordisk FlexPen®)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of T2DM Treated with basal insulin for ≥ 6 months, with current dose stable for ≥ 6 weeks of ≥ 0.3 U/kg/day, with or without anti-hyperglycemic agents and in whom the Investigator feels advancement from basal to basal and bolus therapy is needed for the patient A1C 7.5-11.0% by central lab value at screening visit Already perform self-monitoring of blood glucose (SMBG) and willing to test blood glucose (BG) over the course of the study Body Mass Index of ≤ 40 kg/m2 Exclusion Criteria: Currently on or has been treated in the past year with insulin regimens that include bolus insulins except the need for insulins in the settings of acute illness or hospitalization History of type 1 diabetes mellitus (T1DM), or diabetic ketoacidosis (DKA), or secondary forms of diabetes such as cystic fibrosis Known hypersensitivity or allergy to insulin-glargine or its excipients or any other insulins Two or more severe hypoglycemic episodes within the prior year Hypoglycemia unawareness defined by history History of proliferative diabetic retinopathy Is currently unstable and/or has moderate-to-severe medical illness in the Investigator's judgment Uncontrolled hypertension (either treated or untreated) defined as a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 100 mmHg at screening History of recent major surgery within 6 months, or minor surgery within 3 months (such as appendectomy) prior to screening visit, or a planned surgery during the study period History of bariatric surgery Active chronic infections Women of child-bearing age who are pregnant, planning pregnancy, breast-feeding, or, if capable of pregnancy, are not practicing contraception if heterosexually active Known hypersensitivity to plastics/polymers/adhesives Known difficulties with adherence of adhesives, bandages, or dressings Participated in any research study within the past 30 days Currently participating in another investigational trial Use of short term or chronic systemic steroids within three months of entry into the study or likelihood that same might be required during the conduct of the study

Ages Eligible for Study
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Minimum Age: 22 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bolus Insulin Patch (Calibra Finesse)<br>Use of the wearable patch to deliver meal-related bolus insulin dose | Device: Bolus Insulin Patch (Calibra Finesse)<br> <br> |
| Active Comparator: Insulin Pen (Novo-Nordisk FlexPen®)<br>Use of the pen device to deliver meal-related bolus insulin dose | Device: Insulin Pen (Novo-Nordisk FlexPen®)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy | Change in A1C, with bolus insulin dosing with patch versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With A1C ≤7.0% at Week 24 | Number of patients with A1C ≤7.0% at week 24 | 24 weeks | 
| Change in Percent of Glucose Values of Continuous Glucose Monitoring (CGM) Measurements Within Targeted Range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) From Baseline to Week 24 | Change in percent of glucose values of Continuous Glucose Monitoring (CGM) measurements within targeted range of 71 and 180 mg/dl (4.0 and 10.0 mmol/l) from baseline to week 24 (in a subset of patients) | 24 weeks | 
| Change in A1C From Baseline to Week 44 | Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy | 44 weeks | 
| Number of Patients With A1C ≤7.0% at Week 44 | Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy | 44 weeks | 
| Change in A1C From Week 24 to Week 44 | Change in A1C from week 24 to week 44 after basal and bolus insulin therapy | 44 weeks | 
| Number of Participants With Severe Hypoglycemic Event | An event requiring the assistance of another person to actively administer carbohydrate (including IV dextrose), glucagon, or other resuscitative actions. Neurological recovery attributable to the restoration of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. | 44 weeks |