Clinical Trial Results:
The Effect of Sitagliptin on Glucagon Dynamics and Incretin Hormones During Mild Hypoglycemia in Elderly Patients with Metformin-Treated Type 2 Diabetes
Summary
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EudraCT number |
2014-002685-70 |
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) |
2014-002685-70 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 |
300A
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02256189 | ||
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 assess if sitagliptin can improve the glucagon secretory response to mild hypoglycemia in elderly patients with metformin-treated 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 |
Sitagliptin versus placebo | ||
Actual start date of recruitment |
15 Dec 2014
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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) |
0
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From 65 to 84 years |
28
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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 |
Investigator, Monitor, Data analyst, Subject | |||||||||
Blinding implementation details |
Patients received sitagliptin or placebo first, then placebo or sitagliptin. Randomization and blinding were handled by the University hospital pharmacist.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Sitagliptin | |||||||||
Arm description |
Sitagliptin 100mg once daily for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by placebo treatment for 4 weeks followed by a hypoglycaemic clamp. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Sitagliptin
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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 |
100 mg once daily
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Arm title
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Placebo | |||||||||
Arm description |
Placebo treatment for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by treatment with sitagliptin 100 mg daily for four weeks followed by a hypoglycaemic clamp. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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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 |
One placebo tablet Daily for four weeks
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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 |
Sitagliptin
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Reporting group description |
Sitagliptin 100mg once daily for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by placebo treatment for 4 weeks followed by a hypoglycaemic clamp. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo treatment for four weeks followed by a hyperinsulinaemic hypoglycaemic clamp. Thereafter a 4 weeks wash out period followed by treatment with sitagliptin 100 mg daily for four weeks followed by a hypoglycaemic clamp. |
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End point title |
Glucagon levels at 3.5 mmol/L glucose during hypoglycaemic clamp | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
30 min after start of hypoglycaemia clamp
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Statistical analysis title |
t-test | ||||||||||||
Comparison groups |
Sitagliptin v Placebo
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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 |
= 0.009 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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End point title |
Glucagon levels at 3.1 mmol/L glucose during hypoglycaemic clamp | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
60 min after start of hypoglycaemia clamp
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Statistical analysis title |
t-test | ||||||||||||
Comparison groups |
Sitagliptin v Placebo
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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 |
= 0.18 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Four 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 |
Sitagliptin
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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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/29645341 |