A Phase 4 interventional study of Sitagliptin and Glimepiride in Diabetes Mellitus Type 2, sponsored by GWT-TUD GmbH. Terminated at 1 site in Germany. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by GWT-TUD GmbH · Phase 4, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 4 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →GWT-TUD GmbH is the lead sponsor of 39 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients receiving Sitagliptin 100 mg+ Glimepiride-placebo (adapted dosage)
Drug: Sitagliptin · Drug: Glimepiride-Placebo
Glimepiride (adapted dosage) + Sitagliptin 100 mg Placebo
Drug: Glimepiride · Drug: Sitagliptin-Placebo
Sitagliptin will be given in a daily dosage of 100 mg
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
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
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.
Time frame: 12 weeks (at baseline and at EOT)
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)
Time frame: 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)
Time frame: 12 weeks (at baseline and at EOT)
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.
| Milestone | Arm A | Arm B |
|---|---|---|
| Started | 2 | 2 |
| Completed | 2 | 2 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
measurement of nocturnal ventricular arrhythmias at baseline and EOT (after 12 weeks of treatment) - per patient, couplets per patient, triplets per patient)
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Continuous(years) | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | Total |
|---|---|---|---|
| Mean | 59 ± 2.82 | 69 ± 9.89 | 64 ± 6.35 |
| Sex: Female, Male(Participants) | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 2 | 4 |
| Region of Enrollment(participants) | Arm A: Sitagliptin 100 mg+ Glimepiride-placebo (Adapted Dose) | Arm B: Glimepiride (Adapted Dose) + Sitagliptin 100 mg Placebo | Total |
|---|---|---|---|
| Germany | 2 | 2 | 4 |
Plan to share: No
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