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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003761-28 | EudraCT Number |
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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus Insulin Patch (Calibra Finesse) | Experimental | Use of the wearable patch to deliver meal-related bolus insulin dose |
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| Insulin Pen (Novo-Nordisk FlexPen®) | Active Comparator | Use of the pen device to deliver meal-related bolus insulin dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bolus Insulin Patch (Calibra Finesse) | Device |
| ||
| Insulin Pen (Novo-Nordisk FlexPen®) |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard M Bergenstal, MD | International Diabetes Center at Park Nicollet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Phoenix Medical Clinic | Phoenix | Arizona | 85020 | United States | ||
| Advanced Metabolic Care & Research Institute, Inc. (AMCR) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bolus Insulin Patch | Experimental Treatment Arm |
| FG001 | Insulin Pen | Comparator Treatment Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 21, 2015 |
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| Device |
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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 |
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 |
| Escondido |
| California |
| 92025 |
| United States |
| Marin Endocrine Care and Research | Greenbrae | California | 94904 | United States |
| National Research Institute - Wilshire | Los Angeles | California | 90057 | United States |
| Diabetes Research Institute Mills-Peninsula Health Service | San Mateo | California | 94401 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Denver VA Medical Center | Denver | Colorado | 80220 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Physicians Research Associates | Lawrenceville | Georgia | 30046 | United States |
| Endocrine Research Solutions, Inc | Roswell | Georgia | 30076 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center PA | Idaho Falls | Idaho | 83404 | United States |
| Northwestern University The Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| John H. Stroger, Jr. Hospital of Cook County Diabetes Center | Chicago | Illinois | 60612 | United States |
| Iowa Diabetes and Endocrinology Research Center | Des Moines | Iowa | 50314 | United States |
| Cotton-O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| Great Plains Diabetes | Wichita | Kansas | 67212 | United States |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | United States |
| Medstar Health Research Institute | Hyattsville | Maryland | 20782 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Park Nicollet Institute International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| VA Medical Center Cleveland | Cleveland | Ohio | 44106 | United States |
| University Diabetes and Endocrine Consultants | Chattanooga | Tennessee | 37411 | United States |
| Texas Diabetes & Endocrinology, P.A.- Austin | Austin | Texas | 78749 | United States |
| Dallas Diabetes and Endocrine Center | Dallas | Texas | 75230 | United States |
| Baylor Endocrine Center | Dallas | Texas | 75246 | United States |
| Diabetes & Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | United States |
| South Texas Veterans Health Care System | San Antonio | Texas | 78229 | United States |
| Consano Clinical Research | San Antonio | Texas | 78258 | United States |
| Progressive Clinical Research | Bountiful | Utah | 84010 | United States |
| Highland Clinical Research | Salt Lake City | Utah | 84124 | United States |
| Danville Internal Medicine | Danville | Virginia | 24541 | United States |
| Private Practice-Larry Stonesifer | Federal Way | Washington | 98003 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Hopital Avicenne | Bobigny | 93009 | France |
| Hopital Saint-Andre | Bordeaux | 33000 | France |
| Hopital Hotel-Dieu Site Harfleur | Le Creusot | 71200 | France |
| Lapeyronie Hospital, University Hospital Montpellier | Montpellier | 34295 | France |
| Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications | Paris | 75475 | France |
| CHU de Nantes-Hospital Nord Laennec | Saint-Herblain | 44093 | France |
| GHMP les Portes du Sud | Vénissieux | 69200 | France |
| Diabeteszentrum DO-Diabetologisch | Dortmund | 44137 | Germany |
| BAG Unterm Heilig Kreuz Unterm Heilig Kreuz | Fulda | 36037 | Germany |
| Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr. | Mainz | 55116 | Germany |
| Royal United Hospital, Diabetes & Lipid Research Wolfson Centre | Bath | BA1 3NG | United Kingdom |
| Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust | Blackburn | BB2 3HH | United Kingdom |
| Chorley and South Ribble Hospital | Chorley | PR7 1PP | United Kingdom |
| Ninewells Hospital & Medical School Diabetes Support Unit | Dundee | DD1 9SY | United Kingdom |
| Forth Valley Royal Hospital Dept. of Diabetes | Larbert | FK5 4WR | United Kingdom |
| Leicester General Hospital Leicester Diabetes Centre | Leicester | LE5 4PW | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| COMPLETED | 216 |
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| NOT COMPLETED |
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Intent-to-Treat
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| ID | Title | Description |
|---|---|---|
| BG000 | Bolus Insulin Patch | Experimental Treatment Arm |
| BG001 | Insulin Pen | Comparator Treatment Arm |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| A1C | Baseline A1C | Intent-to-treat (ITT) population | Mean | Standard Deviation | A1C % |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The primary outcome measure analysis used a modified intent-to-treat (mITT) population data set which included all the intent-to-treat (ITT) patients who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the last observation carried forward (LOCF) imputation method was used. | Posted | Least Squares Mean | Standard Error | A1C % | 24 weeks |
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| Secondary | Number of Patients With A1C ≤7.0% at Week 24 | Number of patients with A1C ≤7.0% at week 24 | Modified intent-to-treat (mITT) population data set. | Posted | Count of Participants | Participants | 24 weeks |
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| Secondary | 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) | Modified intent-to-treat population data subset. | Posted | Least Squares Mean | Standard Error | % of glucose values | 24 weeks |
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| Secondary | 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 | Only patients with non-missing baseline and endpoint values were included. | Posted | Least Squares Mean | Standard Error | A1C % | 44 weeks |
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| Secondary | 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 | Only patients with non-missing baseline and endpoint values were included. | Posted | Count of Participants | Participants | 44 weeks |
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| Secondary | Change in A1C From Week 24 to Week 44 | Change in A1C from week 24 to week 44 after basal and bolus insulin therapy | Only patients with non-missing week 24 and week 44 values were included. | Posted | Least Squares Mean | Standard Error | A1C % | 44 weeks |
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| Other Pre-specified | 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. | Per Protocol. Only patients with non-missing baseline and endpoint values were included. | Posted | Least Squares Mean | Standard Error | units on a scale | 24 weeks |
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| Other Pre-specified | 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. | Per Protocol. Only patients with non-missing baseline and endpoint values were included. | Posted | Least Squares Mean | Standard Error | units on a scale | 24 weeks |
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| Secondary | 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. | Intent to Treat. All patients randomized. | Posted | Count of Participants | Participants | 44 weeks |
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44 weeks
A SAE is an event that led to death, or serious deterioration in health that either resulted in a life-threatening illness or injury, or permanent impairment of a body structure or body function, or in-patient hospitalization or prolongation of existing hospitalization, or medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function; or that led to fetal distress, fetal death or congenital abnormality or birth defect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bolus Insulin Patch | Experimental Treatment Arm | 1 | 139 | 10 | 139 | 100 | 139 |
| EG001 | Insulin Pen | Comparator Treatment Arm | 2 | 139 | 13 | 139 | 99 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| General Disorders | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Infections and Infestations | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Vascular disorders | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| Neoplasms benign, malignant, and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
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| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Investigations | Investigations | MedDRA 18.0 | Systematic Assessment |
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| Vascular disorders | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
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| Infections and infestations | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Musculoskeletal and connective tissue | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Levy, MD-Chief Medical Officer | Johnson & Johnson Diabetes Companies | 484 328-6128 | BLevy1@its.jnj.com |
| Nov 6, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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