Trial Outcomes & Findings for Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT NCT02373865)
NCT ID: NCT02373865
Last Updated: 2019-02-27
Results Overview
measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.
TERMINATED
PHASE4
4 participants
12 weeks (at baseline and at EOT)
2019-02-27
Participant Flow
In the time period between the start of the clinical trial (march 2015 (approval of German competent authority) and the premature termination (Jan 2017) only 4 patients of originally planned 68 patients could be recruited. Recruitment period started at 09.11.2015 when first patient was enrolled into study.
no pre-assignment details are available for this study
Participant milestones
| Measure |
Arm A
Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)
Sitagliptin: Sitagliptin will be given in a daily dosage of 100 mg
Glimepiride-Placebo: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
|
Arm B
Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
Glimepiride: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Sitagliptin-Placebo: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose)
n=2 Participants
Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)
Sitagliptin: Sitagliptin will be given in a daily dosage of 100 mg
Glimepiride-Placebo: Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
|
Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo
n=2 Participants
Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
Glimepiride: Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Sitagliptin-Placebo: Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 2.82 • n=5 Participants
|
69 years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
64 years
STANDARD_DEVIATION 6.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks (at baseline and at EOT)Population: Due to an impeded recruitment of patients the study was terminated. Between start (March 2015) and premature termination (Jan 2017) only 4 patients could be recruited. The reason for "0" Participants Analyzed provided in the Analysis Population Description is intended to report that data were not reported due to the termination of the study.
measurement of hypoglycemic episodes including event duration at baseline and EOT after 12 weeks of treatment and measurement of time spent below critical values for hypoglycemic episodes are the primary objectives of this study. We will calculate overall episodes/time (5 days) and nocturnal episodes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks (at baseline and at EOT)Population: Due to an impeded recruitment of patients the study was terminated. Between start (March 2015) and premature termination (Jan 2017) only 4 patients could be recruited. The reason for "0" Participants Analyzed provided in the Analysis Population Description is intended to report that data were not reported due to the termination of the study.
measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeks (at baseline and at EOT)Population: Due to an impeded recruitment of patients the study was terminated. Between start (March 2015) and premature termination (Jan 2017) only 4 patients could be recruited. The reason for "0" Participants Analyzed provided in the Analysis Population Description is intended to report that data were not reported due to the termination of the study.
The glycemic profile is defined as the area under the glucose-timeprofile obtained by continuous glucose monitoring (5 days baseline and 5 days after 12 weeks of each treatment)
Outcome measures
Outcome data not reported
Adverse Events
Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose)
Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof. Dr. Markolf Hanefeld
GWT-TUD GmbH, Study center Prof. Hanefeld
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place