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

NCT02542631 | Completed Results

• 2 other identifiers: VP-005252015-003761-28
• Study Type: interventional
• Target: 278
• Locations: 4 countries
• Sites: 52

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy

  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

  24 weeks

Secondary Outcomes (6)

• Number of Patients With A1C ≤7.0% at 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

  24 weeks

• Change in A1C From Baseline to Week 44

  44 weeks

• Number of Patients With A1C ≤7.0% at Week 44

  44 weeks

• Change in A1C From Week 24 to Week 44

  44 weeks

Other Outcomes (2)

• Change in Treatment Satisfaction From Baseline to Week 24

  24 weeks

• Change in Quality of Life From Baseline to Week 24

  24 weeks

Study Arms (2)

Bolus Insulin Patch (Calibra Finesse)

EXPERIMENTAL

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

Device: Bolus Insulin Patch (Calibra Finesse)

Insulin Pen (Novo-Nordisk FlexPen®)

ACTIVE COMPARATOR

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

Device: Insulin Pen (Novo-Nordisk FlexPen®)

Interventions

Bolus Insulin Patch (Calibra Finesse) DEVICE

Bolus Insulin Patch (Calibra Finesse)

Insulin Pen (Novo-Nordisk FlexPen®) DEVICE

Insulin Pen (Novo-Nordisk FlexPen®)

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Calibra Medical, Inc.: lead
• Medpace, Inc.: collaborator

Study Sites (52)

Central Phoenix Medical Clinic

Phoenix, Arizona, 85020, United States

Location

Advanced Metabolic Care & Research Institute, Inc. (AMCR)

Escondido, California, 92025, United States

Location

Marin Endocrine Care and Research

Greenbrae, California, 94904, United States

Location

National Research Institute - Wilshire

Los Angeles, California, 90057, United States

Location

Diabetes Research Institute Mills-Peninsula Health Service

San Mateo, California, 94401, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Physicians Research Associates

Lawrenceville, Georgia, 30046, United States

Location

Endocrine Research Solutions, Inc

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center PA

Idaho Falls, Idaho, 83404, United States

Location

Northwestern University The Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

John H. Stroger, Jr. Hospital of Cook County Diabetes Center

Chicago, Illinois, 60612, United States

Location

Iowa Diabetes and Endocrinology Research Center

Des Moines, Iowa, 50314, United States

Location

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Great Plains Diabetes

Wichita, Kansas, 67212, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

Medstar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Park Nicollet Institute International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

VA Medical Center Cleveland

Cleveland, Ohio, 44106, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Texas Diabetes & Endocrinology, P.A.- Austin

Austin, Texas, 78749, United States

Location

Dallas Diabetes and Endocrine Center

Dallas, Texas, 75230, United States

Location

Baylor Endocrine Center

Dallas, Texas, 75246, United States

Location

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, 78229, United States

Location

South Texas Veterans Health Care System

San Antonio, Texas, 78229, United States

Location

Consano Clinical Research

San Antonio, Texas, 78258, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

Highland Clinical Research

Salt Lake City, Utah, 84124, United States

Location

Danville Internal Medicine

Danville, Virginia, 24541, United States

Location

Private Practice-Larry Stonesifer

Federal Way, Washington, 98003, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Hopital Avicenne

Bobigny, 93009, France

Location

Hopital Saint-Andre

Bordeaux, 33000, France

Location

Hopital Hotel-Dieu Site Harfleur

Le Creusot, 71200, France

Location

Lapeyronie Hospital, University Hospital Montpellier

Montpellier, 34295, France

Location

Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications

Paris, 75475, France

Location

CHU de Nantes-Hospital Nord Laennec

Saint-Herblain, 44093, France

Location

GHMP les Portes du Sud

Vénissieux, 69200, France

Location

Diabeteszentrum DO-Diabetologisch

Dortmund, 44137, Germany

Location

BAG Unterm Heilig Kreuz Unterm Heilig Kreuz

Fulda, 36037, Germany

Location

Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.

Mainz, 55116, Germany

Location

Royal United Hospital, Diabetes & Lipid Research Wolfson Centre

Bath, BA1 3NG, United Kingdom

Location

Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust

Blackburn, BB2 3HH, United Kingdom

Location

Chorley and South Ribble Hospital

Chorley, PR7 1PP, United Kingdom

Location

Ninewells Hospital & Medical School Diabetes Support Unit

Dundee, DD1 9SY, United Kingdom

Location

Forth Valley Royal Hospital Dept. of Diabetes

Larbert, FK5 4WR, United Kingdom

Location

Leicester General Hospital Leicester Diabetes Centre

Leicester, LE5 4PW, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Brian Levy, MD-Chief Medical Officer
• Organization: Johnson & Johnson Diabetes Companies

BLevy1@its.jnj.com

484 328-6128

Study Officials

• Richard M Bergenstal, MD

  International Diabetes Center at Park Nicollet

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: August 1, 2015
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: February 4, 2025
• Results First Posted: November 7, 2018

Record last verified: 2025-01

Locations

GB (7); DE (3); FR (7); US (35)