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Last Updated: February 26, 2024

CLINICAL TRIALS PROFILE FOR LINAGLIPTIN


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505(b)(2) Clinical Trials for Linagliptin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT05641337 ↗ Research on Optimal Strategy of Hypoglycemic Therapy for Cirrhosis With Diabetes Recruiting Huashan Hospital Phase 3 2022-10-01 Poor blood glucose control in liver cirrhosis can aggravate the poor prognosis of patients. Under the background of the increasing number of liver cirrhosis patients with metabolic abnormalities, how to optimize treatment is particularly important. The traditional treatment of diabetes at the stage of liver cirrhosis is limited to insulin intensive therapy, but the incidence of hypoglycemia is high, blood sugar fluctuates greatly, and multiple injections are required. Research shows that insulin therapy has an increased overall mortality compared with non insulin therapy. We used metformin,Ryzodeg and an oral DDP IV enzyme inhibitor as the core combination according to the special pathological mechanism of elevated blood glucose in liver cirrhosis . After preliminary experiments, we found that the program was stable and was not easy to have hypoglycemia, and there was no traditional risk of lactic acid poisoning caused by metformin. We designed an open randomized controlled clinical study, Compared with the traditional insulin intensive treatment scheme, this new combination scheme was compared whether it could improve the blood glucose level, the incidence of hypoglycemia and lactic acid level, the incidence of cirrhosis complications, and the long-term survival rate of liver disease. This study is helpful to optimize the hypoglycemic treatment of cirrhosis with diabetes, and improve the blood glucose and long-term prognosis, The positive evidence of this study contributes to the consensus or guidelines for the treatment of cirrhosis with diabetes.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Linagliptin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00309608 ↗ Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes Completed Boehringer Ingelheim Phase 2 2006-04-01 The objective of the study is to test the efficacy, safety and tolerability of several doses of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks together with metformin in patients with type 2 diabetes mellitus who are not at goal with their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as add-on therapy to metformin for comparison. The influence of several factors (gender, age, weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in this study.
NCT00328172 ↗ Efficacy and Safety of 3 Doses of BI1356 (Linagliptin) in Type 2 Diabetes Patients Completed Boehringer Ingelheim Phase 2 2006-05-01 The objective of the current study is to investigate the efficacy, safety and tolerability of several doses of BI 1356 BS (0.5, 2.5 and 5 mg daily) compared to placebo over 12 weeks of treatment in patients with Type 2 diabetes and insufficient glycemic control. In addition, there will be an open-label treatment arm with metformin for sensitivity measurement with this patient population. Population pharmacokinetics of BI 1356 BS will also be assessed in this study.
NCT00601250 ↗ Efficacy and Safety of B I1356 (Linagliptin) vs. Placebo Added to Metformin Background Therapy in Patients With Type 2 Diabetes Completed Boehringer Ingelheim Phase 3 2008-01-01 The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control
NCT00602472 ↗ BI 1356 (Linagliptin) in Combination With Metformin and a Sulphonylurea in Type 2 Diabetes Completed Boehringer Ingelheim Phase 3 2008-02-01 The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) compared to placebo given for 24 weeks as add-on therapy to metformin in combination with a sulphonylurea in patients with type 2 diabetes mellitus with insufficient glycaemic control.
NCT00621140 ↗ Efficacy and Safety of BI 1356 (Linagliptin) Versus Placebo in Type 2 Diabetic Patients With Insufficient Glycemic Control Completed Boehringer Ingelheim Phase 3 2008-02-01 To investigate efficacy, safety and tolerability of BI 1356 versus placebo
NCT00641043 ↗ Efficacy vs Placebo as Initial Combination Therapy With Pioglitazone Completed Boehringer Ingelheim Phase 3 2008-03-01 The objective of the current study is to investigate the efficacy, safety and tolerability of BI 1356 (Linagliptin) (5 mg / once daily) compared to placebo given for 24 weeks as initial combination therapy with pioglitazone 30 mg in patients with type 2 diabetes mellitus with insufficient glycaemic control.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Linagliptin

Condition Name

Condition Name for Linagliptin
Intervention Trials
Diabetes Mellitus, Type 2 51
Healthy 26
Type 2 Diabetes 12
Type 2 Diabetes Mellitus 10
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Condition MeSH

Condition MeSH for Linagliptin
Intervention Trials
Diabetes Mellitus, Type 2 80
Diabetes Mellitus 80
Renal Insufficiency 7
Insulin Resistance 7
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Clinical Trial Locations for Linagliptin

Trials by Country

Trials by Country for Linagliptin
Location Trials
United States 415
Canada 89
Germany 37
Australia 33
Korea, Republic of 25
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Trials by US State

Trials by US State for Linagliptin
Location Trials
Texas 25
California 23
Florida 23
Ohio 18
Georgia 17
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Clinical Trial Progress for Linagliptin

Clinical Trial Phase

Clinical Trial Phase for Linagliptin
Clinical Trial Phase Trials
Phase 4 35
Phase 3 47
Phase 2 8
[disabled in preview] 46
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Clinical Trial Status

Clinical Trial Status for Linagliptin
Clinical Trial Phase Trials
Completed 103
Recruiting 14
Unknown status 11
[disabled in preview] 10
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Clinical Trial Sponsors for Linagliptin

Sponsor Name

Sponsor Name for Linagliptin
Sponsor Trials
Boehringer Ingelheim 75
Eli Lilly and Company 36
Hospital Regional de Alta Especialidad del Bajio 5
[disabled in preview] 10
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Sponsor Type

Sponsor Type for Linagliptin
Sponsor Trials
Industry 144
Other 91
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