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

Not Applicable

Completed

Conditions: Diabetes Mellitus, Type 2

Registration Number: NCT02542631

Lead Sponsor: Calibra Medical, Inc.

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 278

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy	24 weeks	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients With A1C ≤7.0% at Week 24	24 weeks	Number of patients with A1C ≤7.0% at 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	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)
Change in A1C From Baseline to Week 44	44 weeks	Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy
Number of Patients With A1C ≤7.0% at Week 44	44 weeks	Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy
Change in A1C From Week 24 to Week 44	44 weeks	Change in A1C from week 24 to week 44 after basal and bolus insulin therapy
Number of Participants With Severe Hypoglycemic Event	44 weeks	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.

Trial Locations

Locations (52): Central Phoenix Medical Clinic
🇺🇸
Phoenix, Arizona, United States
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
🇺🇸
Escondido, California, United States
Marin Endocrine Care and Research
🇺🇸
Greenbrae, California, United States
National Research Institute - Wilshire
🇺🇸
Los Angeles, California, United States
Diabetes Research Institute Mills-Peninsula Health Service
🇺🇸
San Mateo, California, United States
Encompass Clinical Research
🇺🇸
Spring Valley, California, United States
Denver VA Medical Center
🇺🇸
Denver, Colorado, United States
Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States
Columbus Regional Research Institute
🇺🇸
Columbus, Georgia, United States
Physicians Research Associates
🇺🇸
Lawrenceville, Georgia, United States
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Central Phoenix Medical Clinic
🇺🇸Phoenix, Arizona, United States