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Premature termination due to insufficient patient recruitement..
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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 diabetes mellitus type 2 (T2DM) patients inadequately controlled on metformin monotherapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage) |
|
| Arm B | Active Comparator | Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin will be given in a daily dosage of 100 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markolf Hanefeld, Prof. Dr. | GWT-TUD GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GWT-TUD GmbH / Studienzentrum Hanefeld | Dresden | 01307 | Germany |
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no pre-assignment details are available for this study
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 12 weeks (at baseline and at EOT) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | 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 |
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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)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Markolf Hanefeld | GWT-TUD GmbH, Study center Prof. Hanefeld | +49 351 44005 | 82 | Markolf.Hanefeld@gwtonline.de |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Glimepiride |
| Drug |
Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg |
|
| Sitagliptin-Placebo | Drug | Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg |
|
| Glimepiride-Placebo | Drug | 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 |
|
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) |
| BG001 | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
| 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) | 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. | Posted | 12 weeks (at baseline and at EOT) |
|
|
| Secondary | 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) | 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. | Posted | 12 weeks (at baseline and at EOT) |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | 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 | 0 | 2 | 0 | 2 | 0 | 2 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |