Clinical Trial Results:
Study of the Effect of Vildagliptin versus Dapagliflozin on Glucagon Response to Mixed Meal in Metformin-treated Subjects with Type 2 Diabetes
Summary
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EudraCT number |
2015-001334-21 |
Trial protocol |
SE |
Global end of trial date |
13 Mar 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Mar 2021
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First version publication date |
10 Mar 2021
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Other versions |
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Summary report(s) |
2015-001334-21 Results |
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 |
350A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02475070 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Lund university
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Sponsor organisation address |
Sölvegatan 19, Lund, Sweden, 22184
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Public contact |
Bo Ahrén, Lund university, 46 462220758, Bo.Ahren@med.lu.se
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Scientific contact |
Bo Ahrén, Lund university, 46 462220758, Bo.Ahren@med.lu.se
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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 |
15 Nov 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
15 Nov 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Mar 2018
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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 |
To compare the effects of vildagliptin versus dapagliflozin on glucagon response to mixed meal ingestion in metformin-treated patients with type 2 diabetes
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Protection of trial subjects |
Subjects with type 2 diabetes
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Background therapy |
Metformin | ||
Evidence for comparator |
Vildagliptin versus Dapagliflozin | ||
Actual start date of recruitment |
01 Sep 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Sweden: 28
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Worldwide total number of subjects |
28
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EEA total number of subjects |
28
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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) |
20
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
28 subjects were recruited through hospitals | |||||||||
Pre-assignment
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Screening details |
Subjects were examined by physician and lab tests were taken | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst | |||||||||
Blinding implementation details |
Patients received vildagliptin or dapagliflozin first, then dapagliflozin or vildagliptin. Randomization and blinding were handled by the University hospital pharamcist.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Vildagliptin | |||||||||
Arm description |
Vildagliptin 50mg twice daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Dapagliflozin 10 mg once daily followed by a meal test. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Vildagliptin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
50 mg twice daily
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Arm title
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Dapagliflozin | |||||||||
Arm description |
Dapagliflozin 10 mg once daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Vildagliptin 50 mg twice daily followed by a meal test. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Dapagliflozin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dispersible tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg once daily
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Vildagliptin
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Reporting group description |
Vildagliptin 50mg twice daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Dapagliflozin 10 mg once daily followed by a meal test. | ||
Reporting group title |
Dapagliflozin
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Reporting group description |
Dapagliflozin 10 mg once daily for two weeks followed by a meal test. This was followed by a 4 weeks wash-out period followed by two week treatment with Vildagliptin 50 mg twice daily followed by a meal test. |
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End point title |
Glucagon response to mixed meal | ||||||||||||
End point description |
Area under the glucagon curve (AUC) for glucagon after mixed meal ingestion
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End point type |
Primary
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End point timeframe |
4 hours
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Statistical analysis title |
t-test | ||||||||||||
Statistical analysis description |
t-test for mean between the groups
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Comparison groups |
Vildagliptin v Dapagliflozin
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.001 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||
Confidence interval |
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End point title |
Fasting glucagon | ||||||||||||
End point description |
Fasting glucagon after two weeks of treatment with either vildagliptin or dapagliflozin
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End point type |
Secondary
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End point timeframe |
Two weeks
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Statistical analysis title |
t-test | ||||||||||||
Statistical analysis description |
t-test of difference in means
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Comparison groups |
Vildagliptin v Dapagliflozin
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority | ||||||||||||
P-value |
= 0.032 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Two weeks
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
Vildagliptin
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Dapagliflozin
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/29498469 |