Clinical Trial Results:
Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Subjects Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents
Summary
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EudraCT number |
2015-003761-28 |
Trial protocol |
DE |
Global end of trial date |
31 Aug 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jun 2022
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First version publication date |
26 Jun 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VP-00525
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02542631 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Johnson & Johnson Diabetes Companies
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Sponsor organisation address |
965 Chesterbrook Boulevard, Wayne, Pennsylvania, United States, 19087
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Public contact |
Clinical Registry Group, Johnson & Johnson Diabetes Companies, clinicaltrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Johnson & Johnson Diabetes Companies, clinicaltrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Aug 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Aug 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was to compare Finesse to a Pen to initiate and maintain bolus insulin dosing assessed by comparing change in glycated hemoglobin (A1C) from Baseline to the completion of 24 weeks of basal and bolus insulin therapy on each treatment.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety was evaluated based on treatment-emergent adverse events, adverse device effect, serious adverse events, serious adverse device effect, hypoglycemic events, physical examination findings, vital signs, body weight, body mass index, clinical laboratory parameters (including serum chemistry, hematology, and urinalysis) and concomitant medication monitoring.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Aug 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 217
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Country: Number of subjects enrolled |
France: 33
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Country: Number of subjects enrolled |
Germany: 6
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Country: Number of subjects enrolled |
United Kingdom: 22
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Worldwide total number of subjects |
278
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EEA total number of subjects |
39
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
192
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From 65 to 84 years |
86
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects took part in the study at 53 investigative sites in France, Germany, the United Kingdom, and the United States from 01 August 2015 to 31 August 2017. | |||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 388 subjects were screened, 110 subjects were screen failures mainly due to not meeting inclusion criteria and 278 subjects were randomised to receive study treatment. | |||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Bolus Insulin Patch | |||||||||||||||||||||||||||||||||||||||
Arm description |
Experimental Treatment Arm | |||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Bolus Insulin Patch
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Transdermal patch
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Routes of administration |
Transdermal use
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Dosage and administration details |
Bolus insulin dosing with Finesse up to 24 months.
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Arm title
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Insulin Pen | |||||||||||||||||||||||||||||||||||||||
Arm description |
Comparator Treatment Arm | |||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Insulin Pen
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Bolus insulin dosing with Pen device up to 24 months.
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Baseline characteristics reporting groups
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Reporting group title |
Bolus Insulin Patch
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Reporting group description |
Experimental Treatment Arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Insulin Pen
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Reporting group description |
Comparator Treatment Arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Bolus Insulin Patch
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Reporting group description |
Experimental Treatment Arm | ||
Reporting group title |
Insulin Pen
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Reporting group description |
Comparator Treatment Arm |
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End point title |
Change in A1C from Baseline to the Completion of 24 Weeks of Basal and Bolus Insulin Therapy | ||||||||||||
End point description |
The primary outcome measure analysis used a modified intent-to-treat (mITT) population data set which included all ITT subjects 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.
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End point type |
Primary
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End point timeframe |
Baseline to Week 24
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | ||||||||||||
Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
274
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Analysis specification |
Pre-specified
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Analysis type |
[1] | ||||||||||||
P-value |
< 0.0001 [2] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-0.09
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.32 | ||||||||||||
upper limit |
0.14 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.12
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Notes [1] - 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 standard deviation (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%. ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures. [2] - 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%. |
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End point title |
Number of Subjects with A1C less than or equal to (<=) 7.0 Percent (%) at Week 24 | |||||||||
End point description |
Number of subjects with A1C <=7.0% at Week 24 were reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
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End point type |
Secondary
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End point timeframe |
24 weeks
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | |||||||||
Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
274
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.26 [3] | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
1.3
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.81 | |||||||||
upper limit |
2.14 | |||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.25
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Notes [3] - 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. |
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End point 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 | ||||||||||||
End point description |
Change in percent of glucose values of CGM measurements within targeted range of 71 and 180 milligram per deciliter (mg/dl) (4.0 and 10.0 millimoles per liter [mmol/l]) from baseline to week 24 (in a subset of subjects) was reported. The CGM analysis set included all ITT subjects who had CGM measurements at a 1 to 2 week period of Week 2 to Week 0 and a 1 to 2 week period from Week 22 to Week 24.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 24
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | ||||||||||||
Statistical analysis description |
ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
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Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
101
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.38 [4] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-2.97
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-9.63 | ||||||||||||
upper limit |
3.7 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
3.36
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Notes [4] - Statistical test of device effects was conducted at a 2-sided alpha level of 0.05, and CI was calculated at 95%, 2-sided. |
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End point title |
Change in A1C from Baseline to Week 44 | ||||||||||||
End point description |
Change in A1C from baseline to the completion of 44 weeks of basal and bolus insulin therapy was reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 44
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | ||||||||||||
Statistical analysis description |
ANCOVA model with treatment group as a factor and baseline value as a covariate was used to compare devices for continuous measures.
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Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
217
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.99 [5] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.28 | ||||||||||||
upper limit |
0.28 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.14
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Notes [5] - 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. |
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End point title |
Number of Subjects with A1C <=7.0% at Week 44 | |||||||||
End point description |
Number of subjects with A1C <=7.0% after 44 weeks of basal and bolus insulin therapy were reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
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End point type |
Secondary
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End point timeframe |
Baseline to Week 44
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | |||||||||
Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
217
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.71 [6] | |||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
1.1
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.64 | |||||||||
upper limit |
1.93 | |||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.28
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Notes [6] - 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. |
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End point title |
Change in A1C from Week 24 to Week 44 | ||||||||||||
End point description |
Change in A1C from week 24 to week 44 after basal and bolus insulin therapy were reported. The secondary outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
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End point type |
Secondary
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End point timeframe |
Week 24 to Week 44
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | ||||||||||||
Statistical analysis description |
ANCOVA model with treatment group as a factor and week 24 value as a covariate was used to compare devices for continuous measures.
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Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
217
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 0.52 [7] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
0.06
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.12 | ||||||||||||
upper limit |
0.24 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.09
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Notes [7] - 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. |
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End point title |
Number of Subjects with Severe Hypoglycemic Event | |||||||||
End point description |
An event requiring the assistance of another person to actively administer carbohydrate (including intravenous 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. The ITT analysis set consisted of all randomized subjects who initiated bolus insulin therapy.
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End point type |
Secondary
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End point timeframe |
44 weeks
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | |||||||||
Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
278
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
= 1 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Change in Treatment Satisfaction from Baseline to Week 24 | ||||||||||||
End point 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. The other pre-specified outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
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End point type |
Other pre-specified
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End point timeframe |
Baseline to Week 24
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | ||||||||||||
Statistical analysis description |
ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.
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Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
241
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 [8] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
9.16
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
3.65 | ||||||||||||
upper limit |
14.67 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.8
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Notes [8] - 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. |
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End point title |
Change in Diabetes-specific Quality of Life from Baseline to Week 24 | ||||||||||||
End point 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. The pre-specified outcome measure analysis used a mITT population data set which included all the ITT subjects who had a baseline A1C and at least one post-baseline A1C measurement. For missing values, the LOCF imputation method was used.
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End point type |
Other pre-specified
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End point timeframe |
Baseline to Week 24
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Statistical analysis title |
Bolus Insulin Patch versus Insulin Pen | ||||||||||||
Statistical analysis description |
ANCOVA model with change in score as dependent variable, treatment as factor, and baseline score as a covariate was used to compare devices.
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Comparison groups |
Bolus Insulin Patch v Insulin Pen
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Number of subjects included in analysis |
247
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.03 [9] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
4.32
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
0.33 | ||||||||||||
upper limit |
8.32 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
2.03
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Notes [9] - 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. |
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Adverse events information
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Timeframe for reporting adverse events |
44 weeks
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Adverse event reporting additional description |
SAE: event that led to death; life-threatening illness or injury; impairment of body structure or function; in-patient or prolongation of hospitalisation; medical or surgical intervention to prevent life threatening illness or injury; impairment to body structure or function; or fetal distress or death; congenital abnormality; birth defect.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Insulin Pen
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Reporting group description |
Comparator Treatment Arm | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bolus Insulin Patch
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Reporting group description |
Experimental Treatment Arm | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 3% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |