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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Bolus Insulin Patch (Calibra Finesse); Device: Insulin Pen (Novo-Nordisk FlexPen®)

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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93009
    • Hôpital Avicenne
  • Bordeaux, France, 33000
    • Hôpital Saint-André
  • Le Creusot, France, 71200
    • Hopital Hotel-Dieu Site Harfleur
  • Montpellier cedex 5, France, 34295
    • Lapeyronie Hospital, University Hospital Montpellier
  • Paris, France, 75475
    • Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications
  • Saint-Herblain, France, 44093
    • CHU de Nantes-Hospital Nord Laennec
  • Venissieux, France, 69200
    • GHMP les Portes du Sud
• Germany
  • Dortmund, Germany, 44137
    • Diabeteszentrum DO-Diabetologisch
  • Fulda, Germany, 36037
    • BAG Unterm Heilig Kreuz Unterm Heilig Kreuz
  • Mainz, Germany, 55116
    • Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital, Diabetes & Lipid Research Wolfson Centre
  • Blackburn, United Kingdom, BB2 3HH
    • Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust
  • Chorley, United Kingdom, PR7 1PP
    • Chorley and South Ribble Hospital
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School Diabetes Support Unit
  • Larbert, United Kingdom, FK5 4WR
    • Forth Valley Royal Hospital Dept. of Diabetes
  • Leicester, United Kingdom, LE5 4PW
    • Leicester General Hospital Leicester Diabetes Centre
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Central Phoenix Medical Clinic
  • California
    • Escondido, California, United States, 92025
      • Advanced Metabolic Care & Research Institute, Inc. (AMCR)
    • Greenbrae, California, United States, 94904
      • Marin Endocrine Care and Research
    • Los Angeles, California, United States, 90057
      • National Research Institute - Wilshire
    • San Mateo, California, United States, 94401
      • Diabetes Research Institute Mills-Peninsula Health Service
    • Spring Valley, California, United States, 91978
      • Encompass Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver VA Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Columbus, Georgia, United States, 31904
      • Columbus Regional Research Institute
    • Lawrenceville, Georgia, United States, 30046
      • Physicians Research Associates
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions, Inc
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Diabetes and Osteoporosis Center PA
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University The Feinberg School of Medicine
    • Chicago, Illinois, United States, 60612
      • John H. Stroger, Jr. Hospital of Cook County Diabetes Center
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Iowa Diabetes and Endocrinology Research Center
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton-O'Neil Clinical Research Center
    • Wichita, Kansas, United States, 67212
      • Great Plains Diabetes
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Kentucky Diabetes Endocrinology Center
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • Park Nicollet Institute International Diabetes Center
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • VA Medical Center Cleveland
  • Tennessee
    • Chattanooga, Tennessee, United States, 37411
      • University Diabetes and Endocrine Consultants
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes & Endocrinology, P.A.- Austin
    • Dallas, Texas, United States, 75230
      • Dallas Diabetes and Endocrine Center
    • Dallas, Texas, United States, 75246
      • Baylor Endocrine Center
    • San Antonio, Texas, United States, 78229
      • South Texas Veterans Health Care System
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease Clinic, P.A.
    • San Antonio, Texas, United States, 78258
      • Consano Clinical Research
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research
    • Salt Lake City, Utah, United States, 84124
      • Highland Clinical Research
  • Virginia
    • Danville, Virginia, United States, 24541
      • Danville Internal Medicine
  • Washington
    • Federal Way, Washington, United States, 98003
      • Private Practice-Larry Stonesifer
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bolus Insulin Patch (Calibra Finesse); Use of the wearable patch to deliver meal-related bolus insulin dose	Device: Bolus Insulin Patch (Calibra Finesse)
Active Comparator: Insulin Pen (Novo-Nordisk FlexPen®); Use of the pen device to deliver meal-related bolus insulin dose	Device: Insulin Pen (Novo-Nordisk FlexPen®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Treatment Satisfaction From Baseline to Week 24	Change in treatment satisfaction with insulin delivery system from baseline to week 24 was assessed by self-report on the validated Insulin Delivery System Rating Questionnaire. Scale is 0-100. Higher score is better.	24 weeks
Change in Quality of Life From Baseline to Week 24	Change in Diabetes-Specific Quality of Life (QOL), baseline to week 24. was assessed by self-report on the validated Diabetes Specific Quality of Life Survey. Scale is 0-100. Higher score is better.	24 weeks

Collaborators and Investigators

• Sponsor: Calibra Medical, Inc.
• Collaborators: Medpace, Inc.
• Investigators: Principal Investigator: Richard M Bergenstal, MD, International Diabetes Center at Park Nicollet

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: VP-00525; 2015-003761-28 (EudraCT Number)