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

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ClinicalTrials.gov Identifier: NCT02542631
Recruitment Status : Completed
First Posted : September 7, 2015
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
Calibra Medical, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Device: Bolus Insulin Patch (Calibra Finesse)
Device: Insulin Pen (Novo-Nordisk FlexPen®)
Enrollment 278

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description Experimental Treatment Arm Comparator Treatment Arm
Period Title: Overall Study
Started [1] 139 139
Completed [2] 108 108
Not Completed 31 31
Reason Not Completed
Adverse Event             1             1
Sponsor Termination             1             0
Withdrawal by Subject             11             16
Protocol Violation             1             1
Physician Decision             6             4
Lost to Follow-up             6             5
Death             1             2
Other             2             1
Used Prohibited Medication             2             1
[1]
278
[2]
216
Arm/Group Title Bolus Insulin Patch Insulin Pen Total
Hide Arm/Group Description Experimental Treatment Arm Comparator Treatment Arm Total of all reporting groups
Overall Number of Baseline Participants 139 139 278
Hide Baseline Analysis Population Description
Intent-to-Treat
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 139 participants 139 participants 278 participants
58.1  (9.7) 60.4  (7.9) 59.2  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 139 participants 278 participants
Female
58
  41.7%
52
  37.4%
110
  39.6%
Male
81
  58.3%
87
  62.6%
168
  60.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 139 participants 278 participants
American Indian or Alaska Native
0
   0.0%
1
   0.7%
1
   0.4%
Asian
3
   2.2%
0
   0.0%
3
   1.1%
Native Hawaiian or Other Pacific Islander
4
   2.9%
1
   0.7%
5
   1.8%
Black or African American
12
   8.6%
11
   7.9%
23
   8.3%
White
120
  86.3%
126
  90.6%
246
  88.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
A1C   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  A1C %
Number Analyzed 139 participants 139 participants 278 participants
8.6  (0.9) 8.7  (1.0) 8.7  (1.0)
[1]
Measure Description: Baseline A1C
[2]
Measure Analysis Population Description: Intent-to-treat (ITT) population
1.Primary Outcome
Title Change in A1C From Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy
Hide Description 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
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 136 138
Least Squares Mean (Standard Error)
Unit of Measure: A1C %
-1.69  (0.08) -1.60  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The sample size determination was based on the primary endpoint, A1C change from Baseline to Week 24. Assuming that the true mean difference in A1C change for Finesse versus Pen was -0.1% with a SD of 1.2%, a study population of 250 completers (125 per arm) was required to achieve a power of 90% for non-inferiority with a margin of 0.4%.
Statistical Test of Hypothesis P-Value <0.0001
Comments Non-inferiority p-value was calculated with 2-sided comparison of the difference in treatment effects between Finesse and Pen with a non-inferiority margin of 0.4%.
Method ANCOVA
Comments ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.32 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With A1C ≤7.0% at Week 24
Hide Description Number of patients with A1C ≤7.0% at week 24
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population data set.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 136 138
Measure Type: Count of Participants
Unit of Measure: Participants
85
  62.5%
77
  55.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.81 to 2.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Description 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)
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat population data subset.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 52 49
Least Squares Mean (Standard Error)
Unit of Measure: % of glucose values
26.87  (2.33) 29.84  (2.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method ANCOVA
Comments ACNOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.97
Confidence Interval (2-Sided) 95%
-9.63 to 3.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.36
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in A1C From Baseline to Week 44
Hide Description Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy
Time Frame 44 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and endpoint values were included.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: A1C %
-1.63  (0.10) -1.63  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method ANCOVA
Comments ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.28 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Patients With A1C ≤7.0% at Week 44
Hide Description Number of patients with A1C ≤7.0% after 44 weeks of basal and bolus insulin therapy
Time Frame 44 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing baseline and endpoint values were included.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 108 109
Measure Type: Count of Participants
Unit of Measure: Participants
70
  64.8%
68
  62.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.64 to 1.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.28
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in A1C From Week 24 to Week 44
Hide Description Change in A1C from week 24 to week 44 after basal and bolus insulin therapy
Time Frame 44 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with non-missing week 24 and week 44 values were included.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 108 109
Least Squares Mean (Standard Error)
Unit of Measure: A1C %
0.12  (0.06) 0.07  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method ANCOVA
Comments ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.12 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.09
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Severe Hypoglycemic Event
Hide Description 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.
Time Frame 44 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. All patients randomized.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 139 139
Measure Type: Count of Participants
Unit of Measure: Participants
3
   2.2%
3
   2.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Change in Treatment Satisfaction From Baseline to Week 24
Hide Description 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.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol. Only patients with non-missing baseline and endpoint values were included.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 124 117
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
13.63  (1.94) 4.47  (2.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method ANCOVA
Comments ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.16
Confidence Interval (2-Sided) 95%
3.65 to 14.67
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.80
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Change in Quality of Life From Baseline to Week 24
Hide Description 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.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per Protocol. Only patients with non-missing baseline and endpoint values were included.
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description:
Experimental Treatment Arm
Comparator Treatment Arm
Overall Number of Participants Analyzed 124 123
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.37  (1.43) -1.95  (1.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bolus Insulin Patch, Insulin Pen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and confidence interval (CI) was calculated at 95%, 2-sided.
Method ANCOVA
Comments ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.32
Confidence Interval (2-Sided) 95%
0.33 to 8.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.03
Estimation Comments [Not Specified]
Time Frame 44 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Bolus Insulin Patch Insulin Pen
Hide Arm/Group Description Experimental Treatment Arm Comparator Treatment Arm
All-Cause Mortality
Bolus Insulin Patch Insulin Pen
Affected / at Risk (%) Affected / at Risk (%)
Total   1/139 (0.72%)      2/139 (1.44%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bolus Insulin Patch Insulin Pen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/139 (7.19%)      13/139 (9.35%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  0/139 (0.00%)  0 1/139 (0.72%)  1
Cardiac disorders     
Cardiac disorders  1  5/139 (3.60%)  7 2/139 (1.44%)  2
Gastrointestinal disorders     
Gastrointestinal disorders  1  1/139 (0.72%)  1 0/139 (0.00%)  0
General disorders     
General Disorders  1  2/139 (1.44%)  3 0/139 (0.00%)  0
Infections and infestations     
Infections and Infestations  1  0/139 (0.00%)  0 3/139 (2.16%)  3
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications  1  2/139 (1.44%)  2 2/139 (1.44%)  3
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  0/139 (0.00%)  0 1/139 (0.72%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant, and unspecified  1  0/139 (0.00%)  0 2/139 (1.44%)  2
Nervous system disorders     
Nervous system disorders  1  1/139 (0.72%)  1 2/139 (1.44%)  2
Vascular disorders     
Vascular disorders  1  1/139 (0.72%)  1 2/139 (1.44%)  2
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3.0%
Bolus Insulin Patch Insulin Pen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/139 (71.94%)      99/139 (71.22%)    
Gastrointestinal disorders     
Gastrointestinal disorders  1  23/139 (16.55%)  37 21/139 (15.11%)  31
General disorders     
General disorders  1  28/139 (20.14%)  39 15/139 (10.79%)  15
Infections and infestations     
Infections and infestations  1  51/139 (36.69%)  84 60/139 (43.17%)  85
Investigations     
Investigations  1  10/139 (7.19%)  10 14/139 (10.07%)  14
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue  1  34/139 (24.46%)  48 32/139 (23.02%)  42
Nervous system disorders     
Nervous system disorders  1  13/139 (9.35%)  15 16/139 (11.51%)  19
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic, and mediastinal disorders  1  14/139 (10.07%)  18 17/139 (12.23%)  22
Vascular disorders     
Vascular disorders  1  12/139 (8.63%)  12 8/139 (5.76%)  9
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Brian Levy, MD-Chief Medical Officer
Organization: Johnson & Johnson Diabetes Companies
Phone: 484 328-6128
Responsible Party: Calibra Medical, Inc.
ClinicalTrials.gov Identifier: NCT02542631     History of Changes
Other Study ID Numbers: VP-00525
2015-003761-28 ( EudraCT Number )
First Submitted: September 3, 2015
First Posted: September 7, 2015
Results First Submitted: August 30, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018