Diabetes Mellitus Type 2 Clinical Trial
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
Verified date | October 2018 |
Source | GWT-TUD GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - type 2 diabetes - age 40-80 years - stable dose of = 1500 mg metformin or maximal tolerated dose of metformin for > 6 weeks - HbA1c = 7 % - = 9.0% for age < 65 years and = 7.5 % - = 9.0% for age = 65 years - able and trained to perform SMBG - the informed consent form must be signed before any study specific tests or procedures are done - ability to understand and follow study-related instructions Exclusion Criteria: - Type 1 diabetes - previous treatment with insulin, GLP1 analogues and SU in < 6 month - HbA1c > 9 % or FPG > 15 mmol/l at randomization - renal impairment with eGFR < 60 ml/min - medical history of severe hypoglycemia defined as necessity of medical assistance in < 1 year - major cardiovascular event (MACE) in medical history < 6 months - preexisting atrial fibrillation, , AV block =II degree, pace-maker, implanted defibrillator - major cardiovascular event in medical history < 6 months - heart failure NYHA = III - contraindications to glimepiride and sitagliptin or to any excipients according to product information - severe cognitive deficits - Patients who are disable to read and understand informative aspects of the trial - Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s) - Inability to comply with study procedures - Pregnant or breast-feeding woman and woman without adequate method of contraception |
Country | Name | City | State |
---|---|---|---|
Germany | GWT-TUD GmbH / Studienzentrum Hanefeld | Dresden |
Lead Sponsor | Collaborator |
---|---|
GWT-TUD GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | |
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) | 12 weeks (at baseline and at EOT) |
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