Trial · NCT02373865
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
NCT02373865, Phase 4, Terminated, GWT-TUD GmbH; results first posted 2019-02-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes. Trials, record NCT02373865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02373865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
- NCT number
- NCT02373865
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 4 participants, actual
- Lead sponsor
- GWT-TUD GmbH
- Conditions
- Diabetes Mellitus Type 2
- Interventions
- Sitagliptin, Glimepiride, Sitagliptin-Placebo, Glimepiride-Placebo
- First posted
- 2015-02-27
- Last updated
- 2019-02-27
- Results first posted
- 2019-02-27
- Limitations and caveats
Limitations of the study: deceleration of patient recruitment, break up of patient recruitment, descriptive reporting of patient characteristics of 4 enrolled patients (no statistically reliable results are available)
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride | 12 weeks (at baseline and at EOT) | 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. |
| Secondary | Occurence and Number of Nocturnal Ventricular Arrhythmias | 12 weeks (at baseline and at EOT) | measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient) |
| Secondary | Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride | 12 weeks (at baseline and at EOT) | 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) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride | 12 weeks (at baseline and at EOT) | 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. | ||
| SECONDARY | Occurence and Number of Nocturnal Ventricular Arrhythmias | 12 weeks (at baseline and at EOT) | 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. | ||
| SECONDARY | Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride | 12 weeks (at baseline and at EOT) | 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. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 2 | |
| Overall Study | STARTED | Arm B | 2 | |
| Overall Study | COMPLETED | Arm A | 2 | |
| Overall Study | COMPLETED | Arm B | 2 | |
| Overall Study | NOT COMPLETED | Arm A | 0 | |
| Overall Study | NOT COMPLETED | Arm B | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | 0 | 2 |
| Total, all-cause mortality | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | 0 | 2 |
| Total, other adverse events | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | 0 | 2 |
| Total, other adverse events | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | 0 | 2 |
| Total, serious adverse events | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | 0 | 2 |
| Total, serious adverse events | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) vs Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo: deaths from any cause | Trial comparisons |
| Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) vs Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02373865
GET https://conductscience.org/api/trials/v1/NCT02373865/registered