Clinical trial NCT02542631: Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Calibra Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
First posted: 2015-09-07
Enrollment: 278
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of Patients With A1C ≤7.0% at Week 24
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: Change in A1C From Baseline to Week 44
timeFrame: 44 weeks
measure: Number of Patients With A1C ≤7.0% at Week 44
timeFrame: 44 weeks
measure: Change in A1C From Week 24 to Week 44
timeFrame: 44 weeks
measure: Number of Participants With Severe Hypoglycemic Event
timeFrame: 44 weeks
Other outcomes:
measure: Change in Treatment Satisfaction From Baseline to Week 24
timeFrame: 24 weeks
measure: Change in Quality of Life From Baseline to Week 24
timeFrame: 24 weeks
Locations:
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Escondido
country: United States
facility: Advanced Metabolic Care & Research Institute, Inc. (AMCR)
state: California
city: Greenbrae
country: United States
facility: Marin Endocrine Care and Research
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: San Mateo
country: United States
facility: Diabetes Research Institute Mills-Peninsula Health Service
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Lawrenceville
country: United States
facility: Physicians Research Associates
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions, Inc
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center PA
state: Idaho
city: Chicago
country: United States
facility: Northwestern University The Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger, Jr. Hospital of Cook County Diabetes Center
state: Illinois
city: Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center
state: Kansas
city: Wichita
country: United States
facility: Great Plains Diabetes
state: Kansas
city: Lexington
country: United States
facility: Kentucky Diabetes Endocrinology Center
state: Kentucky
city: Hyattsville
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: Park Nicollet Institute International Diabetes Center
state: Minnesota
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: VA Medical Center Cleveland
state: Ohio
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.- Austin
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Baylor Endocrine Center
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Clinic, P.A.
state: Texas
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
city: San Antonio
country: United States
facility: Consano Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Danville
country: United States
facility: Danville Internal Medicine
state: Virginia
city: Federal Way
country: United States
facility: Private Practice-Larry Stonesifer
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Bobigny
country: France
facility: Hopital Avicenne
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Le Creusot
country: France
facility: Hopital Hotel-Dieu Site Harfleur
city: Montpellier cedex 5
country: France
facility: Lapeyronie Hospital, University Hospital Montpellier
city: Paris
country: France
facility: Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications
city: Saint-Herblain
country: France
facility: CHU de Nantes-Hospital Nord Laennec
city: Venissieux
country: France
facility: GHMP les Portes du Sud
city: Dortmund
country: Germany
facility: Diabeteszentrum DO-Diabetologisch
city: Fulda
country: Germany
facility: BAG Unterm Heilig Kreuz Unterm Heilig Kreuz
city: Mainz
country: Germany
facility: Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.
city: Bath
country: United Kingdom
facility: Royal United Hospital, Diabetes & Lipid Research Wolfson Centre
city: Blackburn
country: United Kingdom
facility: Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust
city: Chorley
country: United Kingdom
facility: Chorley and South Ribble Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital & Medical School Diabetes Support Unit
city: Larbert
country: United Kingdom
facility: Forth Valley Royal Hospital Dept. of Diabetes
city: Leicester
country: United Kingdom
facility: Leicester General Hospital Leicester Diabetes Centre
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
Study officials:
affiliation: International Diabetes Center at Park Nicollet
name: Richard M Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
References: