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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT02542631

Run by

Calibra Medical, Inc.

People needed

278

Starts

2015-08-01

Expected to finish

2017-08-31

Last updated by the study team

2025-02-04

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Endocrine Research Solutions, Inc — Roswell, Georgia, United States
• Rocky Mountain Diabetes and Osteoporosis Center PA — Idaho Falls, Idaho, United States
• Northwestern University The Feinberg School of Medicine — Chicago, Illinois, United States
• John H. Stroger, Jr. Hospital of Cook County Diabetes Center — Chicago, Illinois, United States
• Iowa Diabetes and Endocrinology Research Center — Des Moines, Iowa, United States
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
• Great Plains Diabetes — Wichita, Kansas, United States
• Kentucky Diabetes Endocrinology Center — Lexington, Kentucky, United States
• Medstar Health Research Institute — Hyattsville, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Park Nicollet Institute International Diabetes Center — Minneapolis, Minnesota, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• VA Medical Center Cleveland — Cleveland, Ohio, United States
• University Diabetes and Endocrine Consultants — Chattanooga, Tennessee, United States
• Texas Diabetes & Endocrinology, P.A.- Austin — Austin, Texas, United States
• Central Phoenix Medical Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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