| Trial ID: | L3093 |
| Source ID: | NCT02373865
|
| Associated Drug: |
Sitagliptin
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| Title: |
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
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| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02373865/results
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Glimepiride|DRUG: Sitagliptin-Placebo|DRUG: Glimepiride-Placebo
|
| Outcome Measures: |
Primary: Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride, 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., 12 weeks (at baseline and at EOT) | Secondary: Occurence and Number of Nocturnal Ventricular Arrhythmias, measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient), 12 weeks (at baseline and at EOT)|Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride, 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), 12 weeks (at baseline and at EOT)
|
| Sponsor/Collaborators: |
Sponsor: GWT-TUD GmbH
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-09
|
| Completion Date: |
2017-01
|
| Results First Posted: |
2019-02-27
|
| Last Update Posted: |
2019-02-27
|
| Locations: |
GWT-TUD GmbH / Studienzentrum Hanefeld, Dresden, 01307, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT02373865
|
