TRADJENTA SUMMARY
TRADJENTA (linagliptin) tablets contain, as the active ingredient, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.
Monotherapy and Combination Therapy
TRADJENTA tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies ].
Important Limitations of Use
TRADJENTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
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NEWS HIGHLIGHTS
Published Studies Related to Tradjenta (Linagliptin)
Linagliptin added to sulphonylurea in uncontrolled type 2 diabetes patients with
moderate-to-severe renal impairment. [2014] Glucose-lowering treatment options are limited for uncontrolled type 2 diabetes
mellitus (T2DM) patients with advanced stages of renal impairment (RI)... These data suggest that linagliptin is a safe and effective
glucose-lowering treatment in T2DM patients with moderate-to-severe RI for whom
sulphonylurea treatment is no longer sufficient.
Linagliptin, a dipeptidyl peptidase-4 inhibitor in development for the treatment
of type 2 diabetes mellitus: a Phase I, randomized, double-blind,
placebo-controlled trial of single and multiple escalating doses in healthy adult
male Japanese subjects. [2010] in humans... CONCLUSIONS: In this short-term study in healthy adult male Japanese volunteers,
Design, statistical analysis and sample size calculation of a phase IIb/III study
of linagliptin versus voglibose and placebo. [2009] BACKGROUND: Many patients with diabetes mellitus (DM) require a combination of
antidiabetic drugs with complementary mechanisms of action to lower their
hemoglobin A1c levels to achieve therapeutic targets and reduce the risk of
cardiovascular complications...
Initial combination of linagliptin and metformin in patients with type 2
diabetes: efficacy and safety in a randomised, double-blind 1-year extension
study. [2013] combination with metformin in patients with type 2 diabetes... CONCLUSION: The initial combination of linagliptin and metformin appears to
Efficacy and safety of linagliptin added to metformin and sulphonylurea in
Chinese patients with type 2 diabetes: a sub-analysis of data from a randomised
clinical trial. [2013] CONCLUSION: Linagliptin in combination with metformin and sulphonylurea has a
Clinical Trials Related to Tradjenta (Linagliptin)
Linagliptin Inpatient Trial [Recruiting]
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.
Rel. BA of Empagliflozin (BI 10773)/Linagliptin FDC Tbl, Comparison With Mono-components, With a Second FDC Tablet and Influence of Food [Completed]
The primary objective of the current study is to investigate the relative bioavailability of
BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test)
compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference),
both in the fasting state. All 42 subjects entered are planned to be included in this
comparison.
The secondary objective is to investigate the relative bioavailability of BI 10773 /
linagliptin fixed dose combination tablet after administration of a standardised high fat,
high caloric meal (formulation A1, Treatment C, Test) compared to BI 10773 / linagliptin
fixed dose combination in the fasting state (formulation A1,Treatment A, Reference). Of the
42 subjects entered 18 subjects are planned to be included in this comparison.
An additional objective is to investigate the relative bioavailability of a second
formulation of the fixed dose combination tablet of BI 10773 / linagliptin (formulation
A3,Treatment D, Test) compared to BI 10773 / linagliptin fixed dose combination tablet
(formulation A1,Treatment A, Reference). Of the 42 subjects entered 24 subjects are planned
to be included in this comparison.
The Effect of LINAGLIPTIN on Inflammation, Oxidative Stress and Insulin Resistance in Obese Type 2 Diabetes Subjects [Recruiting]
This is a single center, prospective randomized double blind, parallel and placebo
controlled study to evaluate oxidative stress and inflammation before and after treatment
with linagliptin for 12 weeks. We will also, testing whether Linagliptin is an insulin
sensitizer.
Effect of Linagliptin on Insulin Sensitivity and Pancreatic Beta Cell Function in Patients With Type 2 Diabetes Mellitus [Recruiting]
This study is planned to evaluate if linagliptin can improve insulin sensitivity in
patients with type 2 diabetes mellitus. In addition, the effect of linagliptin on
pancreatic function will be studied.
Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin [Completed]
The aim of the trial is to assess the relative bioavailability of fixed dose combination
tablets of linagliptin and metformin compared to the administration of two single tablets
(linagliptin and metformin ) in Chinese subjects. The availability of a fixed dose
combination tablet is expected to significantly enhance patients` compliance with
antidiabetic treatment., in particular with concern to the frequent polypharmacy in diabetic
patients.
Reports of Suspected Tradjenta (Linagliptin) Side Effects
Pancreatitis (74),
Blood Glucose Increased (68),
Nausea (68),
Rash (46),
Diarrhoea (35),
Dizziness (28),
Headache (26),
Vomiting (26),
Drug Ineffective (23),
LIP Swelling (21), more >>
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Page last updated: 2014-12-01
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