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

NCT ID: NCT02542631

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-01
• Study Completion Date: 2017-08-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bolus Insulin Patch (Calibra Finesse)

Use of the wearable patch to deliver meal-related bolus insulin dose

Group Type: EXPERIMENTAL

Bolus Insulin Patch (Calibra Finesse)

Intervention Type: DEVICE

Insulin Pen (Novo-Nordisk FlexPen®)

Use of the pen device to deliver meal-related bolus insulin dose

Group Type: ACTIVE_COMPARATOR

Insulin Pen (Novo-Nordisk FlexPen®)

Intervention Type: DEVICE

Interventions

Bolus Insulin Patch (Calibra Finesse)

Intervention Type: DEVICE

Insulin Pen (Novo-Nordisk FlexPen®)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medpace, Inc.

INDUSTRY

Sponsor Role: collaborator

Calibra Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard M Bergenstal, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Center at Park Nicollet

Locations

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

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

Dallas Diabetes and Endocrine Center

Dallas, Texas, United States

Baylor Endocrine Center

Dallas, Texas, United States

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

South Texas Veterans Health Care System

San Antonio, Texas, United States

Consano Clinical Research

San Antonio, Texas, United States

Progressive Clinical Research

Bountiful, Utah, United States

Highland Clinical Research

Salt Lake City, Utah, United States

Danville Internal Medicine

Danville, Virginia, United States

Private Practice-Larry Stonesifer

Federal Way, Washington, United States

Rainier Clinical Research Center

Renton, Washington, United States

Hopital Avicenne

Bobigny, , France

Hopital Saint-Andre

Bordeaux, , France

Hopital Hotel-Dieu Site Harfleur

Le Creusot, , France

Lapeyronie Hospital, University Hospital Montpellier

Montpellier, , France

Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications

Paris, , France

CHU de Nantes-Hospital Nord Laennec

Saint-Herblain, , France

GHMP les Portes du Sud

Vénissieux, , France

Diabeteszentrum DO-Diabetologisch

Dortmund, , Germany

BAG Unterm Heilig Kreuz Unterm Heilig Kreuz

Fulda, , Germany

Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.

Mainz, , Germany

Royal United Hospital, Diabetes & Lipid Research Wolfson Centre

Bath, , United Kingdom

Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust

Blackburn, , United Kingdom

Chorley and South Ribble Hospital

Chorley, , United Kingdom

Ninewells Hospital & Medical School Diabetes Support Unit

Dundee, , United Kingdom

Forth Valley Royal Hospital Dept. of Diabetes

Larbert, , United Kingdom

Leicester General Hospital Leicester Diabetes Centre

Leicester, , United Kingdom

Royal Liverpool University Hospital

Liverpool, , United Kingdom

Countries

United States; France; Germany; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-003761-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VP-00525

Identifier Type: -

Identifier Source: org_study_id