Diabetes Mellitus, Type 2NCT02542631
Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Patients
A study testing Bolus Insulin Patch (Calibra Finesse) and Insulin Pen (Novo-Nordisk FlexPen®) in people with Diabetes Mellitus, Type 2, run by Calibra Medical, Inc. at 52 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Bolus Insulin Patch (Calibra Finesse) and Insulin Pen (Novo-Nordisk FlexPen®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 52 sitesin 4 countries
- Study dates
- 1 Aug 2015to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
52 sites in 4 countries.
52 sites in 4 countries
United States35 sites
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes & Endocrinology, P.A.- Austin
Austin, Texas, 78749
Progressive Clinical Research
Bountiful, Utah, 84010
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411
Northwestern University The Feinberg School of Medicine
Chicago, Illinois, 60611
John H. Stroger, Jr. Hospital of Cook County Diabetes Center
Chicago, Illinois, 60612
VA Medical Center Cleveland
Cleveland, Ohio, 44106
Columbus Regional Research Institute
Columbus, Georgia, 31904
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
Baylor Endocrine Center
Dallas, Texas, 75246
Danville Internal Medicine
Danville, Virginia, 24541
Denver VA Medical Center
Denver, Colorado, 80220
Iowa Diabetes and Endocrinology Research Center
Des Moines, Iowa, 50314
Henry Ford Health System
Detroit, Michigan, 48202
Advanced Metabolic Care & Research Institute, Inc. (AMCR)
Escondido, California, 92025
Private Practice-Larry Stonesifer
Federal Way, Washington, 98003
Marin Endocrine Care and Research
Greenbrae, California, 94904
Medstar Health Research Institute
Hyattsville, Maryland, 20782
Rocky Mountain Diabetes and Osteoporosis Center PA
Idaho Falls, Idaho, 83404
Physicians Research Associates
Lawrenceville, Georgia, 30046
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, 40503
National Research Institute - Wilshire
Los Angeles, California, 90057
Park Nicollet Institute International Diabetes Center
Minneapolis, Minnesota, 55416
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020
Rainier Clinical Research Center
Renton, Washington, 98057
Endocrine Research Solutions, Inc
Roswell, Georgia, 30076
Highland Clinical Research
Salt Lake City, Utah, 84124
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
South Texas Veterans Health Care System
San Antonio, Texas, 78229
Consano Clinical Research
San Antonio, Texas, 78258
Diabetes Research Institute Mills-Peninsula Health Service
San Mateo, California, 94401
Encompass Clinical Research
Spring Valley, California, 91978
SUNY Upstate Medical University
Syracuse, New York, 13210
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606
Great Plains Diabetes
Wichita, Kansas, 67212
France7 sites
Hopital Avicenne
Bobigny, 93009
Hopital Saint-Andre
Bordeaux, 33000
Hopital Hotel-Dieu Site Harfleur
Le Creusot, 71200
Lapeyronie Hospital, University Hospital Montpellier
Montpellier, 34295
Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications
Paris, 75475
CHU de Nantes-Hospital Nord Laennec
Saint-Herblain, 44093
GHMP les Portes du Sud
Vénissieux, 69200
United Kingdom7 sites
Royal United Hospital, Diabetes & Lipid Research Wolfson Centre
Bath, BA1 3NG
Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust
Blackburn, BB2 3HH
Chorley and South Ribble Hospital
Chorley, PR7 1PP
Ninewells Hospital & Medical School Diabetes Support Unit
Dundee, DD1 9SY
Forth Valley Royal Hospital Dept. of Diabetes
Larbert, FK5 4WR
Leicester General Hospital Leicester Diabetes Centre
Leicester, LE5 4PW
Royal Liverpool University Hospital
Liverpool, L7 8XP
Germany3 sites
Diabeteszentrum DO-Diabetologisch
Dortmund, 44137
BAG Unterm Heilig Kreuz Unterm Heilig Kreuz
Fulda, 36037
Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.
Mainz, 55116
About this study
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
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.
Read the 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
- Being tested
- Bolus Insulin Patch (Calibra Finesse), Insulin Pen (Novo-Nordisk FlexPen®)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus Insulin Patch (Calibra Finesse)Device
Insulin Pen (Novo-Nordisk FlexPen®)Device
| Study group | Role | What they receive |
|---|---|---|
| Bolus Insulin Patch (Calibra Finesse) | Experimental | Use of the wearable patch to deliver meal-related bolus insulin dose Receives: 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 Receives: Device: Insulin Pen (Novo-Nordisk FlexPen®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (6)
Number of Patients With A1C ≤7.0% at Week 24
Number of patients with A1C ≤7.0% at week 24
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calibra Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard M Bergenstal, MD, Principal investigator, International Diabetes Center at Park Nicollet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542631
- Sponsor's protocol ID
- VP-00525
- Other IDs
- 2015-003761-28, 2015
- Status last verified
- Jan 2025
- First submitted
- 3 Sep 2015
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02542631
- Acronym / sponsor ID
- VP-00525
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Calibra Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Posted 7 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus Insulin Patch (Calibra Finesse) | Experimental | Device: Bolus Insulin Patch (Calibra Finesse)Use of the wearable patch to deliver meal-related bolus insulin dose |
| Insulin Pen (Novo-Nordisk FlexPen®) | Active comparator | Device: Insulin Pen (Novo-Nordisk FlexPen®)Use of the pen device to deliver meal-related bolus insulin dose |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bolus Insulin Patch (Calibra Finesse) | Device | Bolus Insulin Patch (Calibra Finesse) |
| Insulin Pen (Novo-Nordisk FlexPen®) | Device | Insulin Pen (Novo-Nordisk FlexPen®) |
Primary outcome
Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy
Time frame: 24 weeks
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
6 secondary outcomes
Number of Patients With A1C ≤7.0% at Week 24
Time frame: 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
Time frame: 24 weeks
Change in A1C From Baseline to Week 44
Time frame: 44 weeks
Number of Patients With A1C ≤7.0% at Week 44
Time frame: 44 weeks
Change in A1C From Week 24 to Week 44
Time frame: 44 weeks
Number of Participants With Severe Hypoglycemic Event
Time frame: 44 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard M Bergenstal, MD principal investigator
International Diabetes Center at Park Nicollet
52 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolus Insulin Patch (Calibra Finesse) and Insulin Pen (Novo-Nordisk FlexPen®) in people with Diabetes Mellitus, Type 2, run by Calibra Medical, Inc. at 52 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, France, United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.