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

Calibra Medical

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Device: Bolus Insulin Patch (Calibra Finesse)

Device: Insulin Pen (Novo-Nordisk FlexPen®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02542631

VP-00525

2015-003761-28 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

278 patients

Sex

All

Ages

22 to 75 years old

Volunteers

No Healthy Volunteers

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