Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02373865|
Recruitment Status : Terminated (Premature termination due to insufficient patient recruitement..)
First Posted : February 27, 2015
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2||Drug: Sitagliptin Drug: Glimepiride Drug: Sitagliptin-Placebo Drug: Glimepiride-Placebo||Phase 4|
Type 2 Diabetes is associated with an increased cardiovascular morbidity and mortality. Among patients insufficiently controlled with metformin multimorbidity and polypharmacy is common that makes the patients frail for cardiovascular complications related to hypoglycemic events.
This exploratory double blind randomized active controlled study is designed to assess the effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage of glimepiride as add on therapy in patients with T2DM patients inadequately controlled on metformin monotherapy.
Examinations will be performed as a 5 day recording of subcutaneous glucose concentration (CGMS) and holder ECG (AMEDTEC) at baseline and after a 12 weeks treatment with sitagliptin or glimepiride as active comparators used in combination with metformin.
With recording of nocturnal hypoglycemia and arrhythmias it is aimed to evaluate favorable glycemic profile under treatment with sitagliptin compared to glimepiride. The primary objective is risk of serious HE for both drugs.
The glycemic profile of sitagliptin as add-on therapy to metformin seems to be favorable compared to sulfonylureass such as glimepiride. Treatment with sitagliptin as add-on to metformin therapy causes less glycemic fluctuations and may be associated with lower oxidative stress and down regulation of low grade inflammation. This hypothesis will be tested as an explorative double blind study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized Double Blind Parallel Design Study Comparing Risk of Nocturnal Hypoglycemia and Critical Arrhythmia With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: Arm A
Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)
Sitagliptin will be given in a daily dosage of 100 mg
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
Active Comparator: Arm B
Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg
- Number of Hypoglycemic Episodes (HE) Under Treatment With Sitagliptin Compared to Glimepiride [ Time Frame: 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.
- Occurence and Number of Nocturnal Ventricular Arrhythmias [ Time Frame: 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)
- Glycemic Variability (Profile) of Sitagliptin Compared to Glimepiride [ Time Frame: 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373865
|GWT-TUD GmbH / Studienzentrum Hanefeld|
|Dresden, Germany, 01307|
|Study Director:||Markolf Hanefeld, Prof. Dr.||GWT-TUD GmbH|