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Harvard Business School
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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR TRADJENTA

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Clinical Trials for Tradjenta

Trial ID Title Status Sponsor Phase Summary
NCT01969084 The Effect of Linagliptin on Mitochondrial and Endothelial Function Completed Beth Israel Deaconess Medical Center Phase 4 Investigators propose to examine the effect of 12 weeks of Linagliptin, a diabetes drug, treatment on inflammation as well as vascular and mitochondrial function in diabetic patients. Investigators hypothesize that Linagliptin will reduce the proinflammatory state, improve endothelial function, increase the blood flow at the muscle microcirculation level and improve mitochondrial function. In this study, investigators will perform tests that evaluate the function of small and large blood vessels by employing ultrasound and laser doppler techniques. In addition MRI scans that evaluate the mitochondrial function of the lower extremity muscles at rest and during exercise will also be employed. Forty subjects with Type 2 diabetes will be studied for twelve weeks and half of them will be randomly assigned to receive linagliptin while the other half will receive placebo. All tests will be performed at the beginning and the end of the study.
NCT02004366 Linagliptin Inpatient Trial Recruiting Boston Medical Center Phase 4 A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication or low dose insulin prior to their admission. This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02004366 Linagliptin Inpatient Trial Recruiting Rush University Phase 4 A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication or low dose insulin prior to their admission. This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02004366 Linagliptin Inpatient Trial Recruiting University of Denver Phase 4 A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication or low dose insulin prior to their admission. This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02004366 Linagliptin Inpatient Trial Recruiting Emory University Phase 4 A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication or low dose insulin prior to their admission. This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
NCT02061969 ADA Linagliptin in Long Term Care Recruiting American Diabetes Association Phase 4 This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
NCT02061969 ADA Linagliptin in Long Term Care Recruiting Emory University Phase 4 This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Tradjenta

Condition Name

Condition Name for Tradjenta
Intervention Trials
Type 2 Diabetes 3
Diabetes 2
Type II Diabetes Mellitus 1
SGLT-2 Inhibitors 1
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Condition MeSH

Condition MeSH for Tradjenta
Intervention Trials
Diabetes Mellitus, Type 2 5
Diabetes Mellitus 3
Renal Insufficiency 1
Schizophrenia 1
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Clinical Trial Locations for Tradjenta

Trials by Country

Trials by Country for Tradjenta
Location Trials
United States 9
Netherlands 1
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Trials by US State

Trials by US State for Tradjenta
Location Trials
Georgia 2
Massachusetts 2
District of Columbia 1
Nevada 1
New York 1
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Clinical Trial Progress for Tradjenta

Clinical Trial Phase

Clinical Trial Phase for Tradjenta
Clinical Trial Phase Trials
Phase 4 8
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Clinical Trial Status

Clinical Trial Status for Tradjenta
Clinical Trial Phase Trials
Recruiting 6
Completed 1
Not yet recruiting 1
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Clinical Trial Sponsors for Tradjenta

Sponsor Name

Sponsor Name for Tradjenta
Sponsor Trials
Emory University 2
Northwell Health 1
American Diabetes Association 1
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Sponsor Type

Sponsor Type for Tradjenta
Sponsor Trials
Other 14
Industry 1
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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Teva
US Army
Mallinckrodt
US Department of Justice
Medtronic
Chinese Patent Office
AstraZeneca
Healthtrust

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