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



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:22 - 75
Updated:12/16/2017
Start Date:August 1, 2015
End Date:August 31, 2017

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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.

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.

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
We found this trial at
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Des Moines, Iowa 50314
Principal Investigator: Anuj Bhargava, MD
Phone: 515-643-4872
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823 SW Mulvane St
Topeka, Kansas 66606
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Principal Investigator: Alan Wynne, MD
Phone: 866-872-2349
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Atlanta, Georgia 30309
Principal Investigator: Bruce Bode, MD
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12343 Hunters Chase Drive
Austin, Texas 78729
Principal Investigator: Tira Chaicha-Brom, MD
Phone: 512-334-3505
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Bobigny, 93009
Principal Investigator: Hélène Bihan, MD
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Bountiful, Utah 84010
Principal Investigator: Ralph Wade, DO
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Chattanooga, Tennessee 37403
Principal Investigator: David Huffman, MD
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Principal Investigator: Mark Molitch, MD
Phone: 866-872-2349
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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Chicago, Illinois 60612
Principal Investigator: Leon Fogelfeld, MD
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Cleveland, Ohio 44106
Principal Investigator: Ajay Sood, MD
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Columbus, Georgia 31904
Principal Investigator: Steven Leichter, MD
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Dallas, Texas 75230
Principal Investigator: Julio Rosenstock, MD
Phone: 972-566-5678
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Dallas, Texas 75246
Principal Investigator: Priscilla Hollander, MD
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Danville, Virginia 24541
Principal Investigator: Daniel Pomposini, MD
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Denver, Colorado 80220
Principal Investigator: Neda Rasouli, MD
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Detroit, Michigan 48202
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Escondido, California 92025
Principal Investigator: Timothy Bailey, MD
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Federal Way, Washington 98003
Principal Investigator: Larry Stonesifer, MD
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Greenbrae, California 94904
Principal Investigator: Richard Bernstein, MD
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Hyattsville, Maryland 20782
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Idaho Falls, Idaho 83404
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Lawrenceville, Georgia 30046
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Lexington, Kentucky 40503
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Los Angeles, California 90057
Principal Investigator: Juan Pablo Frias, MD
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Minneapolis, Minnesota 55416
Principal Investigator: Richard Bergenstal, MD
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Phoenix, Arizona 85020
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Principal Investigator: Ronald L Brazg, MD
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Roswell, Georgia 30076
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Salt Lake City, Utah 84124
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San Antonio, Texas 78229
Principal Investigator: Mark Kipnes, MD
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San Antonio, Texas 78258
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San Mateo, California 94401
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Spring Valley, California 91978
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750 East Adams Street
Syracuse, New York 13210
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