Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 2 (t2dm)
Treatments bolus insulin patch (calibra finesse), insulin pen (novo-nordisk flexpen®)
Sponsor Calibra Medical, Inc.
Collaborator Medpace, Inc.
Start date August 2015
End date April 2017
Trial size 280 participants
Trial identifier NCT02542631, VP-00525

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Use of the wearable patch to deliver meal-related bolus insulin dose
bolus insulin patch (calibra finesse)
(Active Comparator)
Use of the pen device to deliver meal-related bolus insulin dose
insulin pen (novo-nordisk flexpen®)

Primary Outcomes

Measure
Change in A1C, with bolus insulin dosing with Finesse versus pen, from baseline to the completion of 24 weeks of basal and bolus insulin therapy.
time frame: 24 weeks

Secondary Outcomes

Measure
Proportion of patients with A1C ≤7.0% at week 24
time frame: 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 (in a subset of patients)
time frame: 24 weeks
Change in A1C from baseline to week 44
time frame: 44 weeks
Proportion of patients with A1C ≤7.0% at week 44
time frame: 44 weeks
Change in A1C from week 24 to week 44
time frame: 44 weeks

Eligibility Criteria

Male or female participants from 22 years up to 75 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Calibra Medical, Inc..