Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02373865
Study type Interventional
Source GWT-TUD GmbH
Contact
Status Terminated
Phase Phase 4
Start date September 2015
Completion date January 2017

See also
  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
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
Active, not recruiting 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
Completed 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
Completed NCT01765517 - Study to Explore the Effects of Probiotics on Endotoxin Levels in Type 2 Diabetes Mellitus Patients N/A