Diabetes Mellitus Type 2 Clinical Trial
Official title:
Multicentric Cross-over Trial to Assess the Glycemic Profiles on 8 Weeks of Vildagliptin and Sitagliptin Treatment, Each, in Type-2 Diabetic Patients With a Pre-existing Cardiovascular Disease Pre-treated With Insulin, Using a PROBE-design
Vildagliptin and Sitagliptin both belong to the class of DPP-4 inhibitors, but differ in
their pharmacokinetic profile as well as in their approved application (Vildagliptin, 2x 50
mg daily, Sitagliptin, 1x 100 mg daily). This leads to distinct results regarding
postprandial blood-glucose normalization as well as protective properties regarding
hypoglycemic episodes - especially during the night. Additionally, in type 1 diabetic
patients a correlation has been described between hypoglycemia and abnormal heart function
(QTc-elongation), which can have severe consequences for the patients. This study aims for
the evaluation of the potency of both drugs to prevent and/or reduce hypoglycemic events in
insulin-dependent type-2 diabetics and furthermore to evaluate the correlation of
hypoglycemic episodes with changes in heart-function measured by Holter-ECG.
The hypothesis is tested, if vildagliptin leads to a more favourable glycemic profile than
sitagliptin and is more potent in protecting from nocturnal abnormalities in heart-function
caused by undetected hypoglycemic episodes.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01267448 -
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
|
Phase 4 | |
| Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
| Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
| Terminated |
NCT02373865 -
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 | |
| Completed |
NCT01305434 -
Mulberry Leaf Extract and Blood Glucose Control in Diabetics
|
Phase 1/Phase 2 | |
| Completed |
NCT01330121 -
Bridging the Gap by Transitional Care
|
N/A | |
| Recruiting |
NCT00992797 -
Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity
|
Phase 2 | |
| Completed |
NCT01580904 -
Impact of Pharmaceutical Care in Diabetics Patients
|
N/A | |
| Active, not recruiting |
NCT00728403 -
Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes
|
Phase 2 | |
| Completed |
NCT00763815 -
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
|
Phase 3 | |
| Active, not recruiting |
NCT00529815 -
Continuous Glucose Monitoring in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT00517465 -
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
|
Phase 1 | |
| Withdrawn |
NCT00417716 -
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
|
Phase 3 | |
| Completed |
NCT00119041 -
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
|
N/A | |
| Withdrawn |
NCT00600236 -
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
|
Phase 3 | |
| Active, not recruiting |
NCT05887635 -
Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus
|
N/A | |
| Completed |
NCT03903965 -
Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
|
||
| Completed |
NCT02666924 -
Cooking Classes for Chinese Canadian Patients Living With Diabetes
|
N/A | |
| Recruiting |
NCT02501850 -
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)
|
Phase 4 |