See. In line with NICE TA315 and NICE TA390, only if triple therapy indicated. Although linagliptin is unlikely to cause low blood sugar, other medicines that you are taking for diabetes alongside it may. Recently, results from an in vitro study of human islet cells exposed to diabetic conditions showed that linagliptin restored -cell proliferation and survival after glucotoxicity, lipotoxicity, and cytokine toxicity.23 In addition to these investigations, published animal studies of linagliptin describe its effect on incretin physiology,13,14 body weight,24 or other extraglycemic effects such as stroke25 and wound healing.2628, After confirmation of glycemic benefits in preclinical studies, the clinical trial program for linagliptin commenced and filing for a US new drug application occurred in July 2010 (Figure 4).29 Phase I and II trials established the clinical dosage of linagliptin 5 mg once daily that was used in the Phase III program.29 Clinical studies of linagliptin included a range of patient populations with regard to disease severity and duration. Amber 2 - Specialist recommendation in line with, Amber 2 - Specialist initiation in line with, Amber 2 - Specialist initiation for the treatment of diabetes in line with, Restricted to dose of 1.2mg only (1.8mg dose is non-formulary and classified grey, Nov 18 APC). Find out how linagliptin treats type 2 diabetes, and how to take it. Switch to alternative cost-effective option. As is standard for a type 2 diabetes clinical development program, the first trials established the safety and efficacy of the drug when used as monotherapy. Treatment for diabetes is usually lifelong. For patients with severe renal impairment ( CrCL less than 3omls/min or end stage renal disease requiring dialysis, 6.25mg once daily is the recommended dose. Therefore, availability of antidiabetic medications that can be used in patients with this condition is a key medical need. Chaykovska L, Alter ML, von Websky K, et al. High-glucose environment enhanced oxidative stress and increased interleukin-8 secretion from keratinocytes: new insights on impaired diabetic wound healing. The overall cardiovascular safety profile of SUs is an area of uncertainty. Patients currently prescribed Lixisenatide should be reviewed and may be continued on their currently therapy where clinically appropriate. DO NOT PRESCRIBE glibenclamide oral suspension (Amglidia . Registered number: 10004395 Registered office: Fulford Grange, Micklefield Lane, Rawdon, Leeds, LS19 6BA. In addition, CARMELINA: CArdiovascular safety and Renal Microvascular outcomE with LINAgliptin in patients With Type 2 Diabetes Mellitus at High Vascular Risk has commenced ({"type":"clinical-trial","attrs":{"text":"NCT01897532","term_id":"NCT01897532"}}NCT01897532).76 This long-term, placebo-controlled study will investigate cardiovascular and renal microvascular outcomes in adults with type 2 diabetes at high cardiovascular risk defined by albuminuria and previous macrovascular disease and/or impaired renal function. Take linagliptin tablets exactly as your doctor tells you to. Effects of adding linagliptin to basal insulin regimen for inadequately controlled type 2 diabetes. If you suspect that you or someone else might have taken an overdose of this medicine go to the accident and emergency department of your local hospital at once. Check with your doctor before taking up any new physical exercise, as this will have an effect on your blood sugar levels and you may need to check your blood or urine levels more regularly. It also reduces the amount of a substance called glucagon being produced by your pancreas. . With increasing duration of type 2 diabetes, patients tend to experience a progressive decline in the ability to maintain adequate glycemic control with antidiabetic therapies, thus necessitating an escalation in medication doses over time (using agents for which this is an option). Darsalia V, Ortster H, Olverling A, et al. A 24-week placebo-controlled study explored the comparative efficacy of this approach, randomizing patients to monotherapy with linagliptin or metformin, or alternatively to linagliptin administered as initial combination therapy with metformin.36 Results demonstrated that initial combination therapy was associated with greater HbA1c reduction compared with either agent given as monotherapy.36 For example, patients randomized to receive 1,000 mg twice-daily metformin monotherapy demonstrated a placebo-adjusted HbA1c reduction of 1.2% (baseline, 8.5%), whereas patients receiving a lower dose of metformin (500 mg twice daily) in combination with linagliptin experienced an adjusted HbA1c reduction of 1.3% (baseline, 8.7%). being unable to get an erection at any time. Lan CC, Wu CS, Huang SM, Wu IH, Chen GS. Empagliflozin in triple therapy in combination with: Empagliflozin in combination with insulin with or without other antidiabetic drugs. Several studies have shown that the underlying physiology of wound healing is altered in diabetic/obese animal models.26,27,63,64 Because possible mechanisms may be related to hyperglycemia, altered levels of signaling hormones (eg, insulin, glucagon, or others) or the effects that these conditions may have on inflammation and cellular remodeling, the precise etiology remains unclear.28 However, data exist to answer the clinical question of whether treatment with antidiabetic therapies can influence the healing of wounds in patients with diabetes. Findings from a meta-analysis of trials of linagliptin, sitagliptin, and saxagliptin have generally demonstrated a mean weight change from baseline within 1% of baseline body weight.50 Therefore, in clinical practice, DPP-4 inhibitors are generally considered weight neutral. Learn about side effects, warnings, dosage, and more. The CAROLINA study is the only prospective cardiovascular outcomes study to directly compare major adverse cardiovascular events of a DPP-4 inhibitor (linagliptin) with a SU (glimepiride).75 Given these considerations, it has been suggested that DPP-4 inhibitors may assume a comparable role in therapy as the SUs,82,83 particularly as additional cardiovascular data on DPP-4 become available. Are sulfonylureas less desirable than DPP-4 inhibitors as add-on to metformin in the treatment of type 2 diabetes? As a further measure of efficacy for glycemic control in this study, patients concomitantly taking insulin demonstrated an insulin-sparing effect in the linagliptin group. A rare side-effect is persistent or severe tummy pain - you should let your doctor know about this if it happens to you. The information on this page is written and peer reviewed by qualified clinicians. Applies to linagliptin: oral tablet. the person is at significant risk of hypoglycaemia or its consequences. Glibenclamide tablets discontinued - see link below for details, Blood glucose test meters formulary - Nottingham & Notts ICB, BMJ infographic: Managing type 2 diabetes in adults, Diabetes in children and young people (NICE NG18), Management of Diabetes (SIGN guideline 116), NICE KTT12: Type 2 diabetes mellitus: medicines optimisation priorities, NICE therapeutic topic: Type 2 diabetes mellitus, NUH Guideline: Management of Hyperosmolar Hyperglycaemic State (HHS) in adults, Type 2 diabetes in adults: management (NG28), Relative cost of injectable antidiabetic agents, Nottinghamshire APC Type 2 Diabetes Guideline, NICE: Patient Decision Aid - Type 2 diabetes in adults: controlling your blood glucose by taking a second medicine, British Association for Psychopharmacology guideline, EMA - Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function, MHRA advice to monitor B12 levels in pts taking metformin, NICE Evidence summary: Metformin for PCOS in women who are not planning pregnancy, NICE: Patient Decision Aid - Type 2 diabetes in adults: agreeing my blood glucose (HbA1c) target, Systematic review of normal release and modified release, UKMI Q&A: Metformin for hirsutism and acne in polycystic ovary syndrome (PCOS), Nottinghamshire APC diabetes treatment guidelines. CPJPG recommended that until more experience is gained, Patient should be counselled that oral semaglutide should be. Linagliptin may cause serious side effects. Notes: When maximum effective dose is reached, a combination regimen must then be selected in an attempt to control blood glucose. one months supply. Linagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. In patients where DKA is suspected or diagnosed, dapagliflozin treatment should be stopped immediately. The dipeptidyl peptidase-4 inhibitor linagliptin attenuates inflammation and accelerates epithelialization in wounds of diabetic ob/ob mice. Place tablet in the mouth, where it will dissolve in seconds and then be swallowed with the saliva. To address this question, CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes is ongoing ({"type":"clinical-trial","attrs":{"text":"NCT01243424","term_id":"NCT01243424"}}NCT01243424).74,75 This study has recruited 6,000 participants with type 2 diabetes who are at increased risk for cardiovascular events. Dosing guides have been produced for this combination product by the manufacturers to reduce the risk of dosing errors (see links below). Linagliptin will help to reduce blood sugar (glucose) levels in people with type 2 diabetes. Effects of the DPP-4 inhibitor, linagliptin, in diet-induced obese rats: a comparison in naive and exenatide-treated animals. These preclinical findings, as well as conflicting reports regarding the effects of DPP-4 inhibitors on blood pressure,55 warranted further investigation of concomitant reninangiotensinaldosterone therapies and linagliptin. Drucker DJ, Philippe J, Mojsov S, Chick WL, Habener JF. Gomis R, Owens DR, Taskinen MR, et al. Efficacy and safety of linagliptin in persons with type 2 diabetes inadequately controlled by a combination of metformin and sulphonylurea: a 24-week randomized study. Glucagon causes your liver to produce more sugar; so, by reducing the amount of glucagon in your body, this also helps to reduce the levels of sugar in your blood. It should not be used to treat type 1 diabetes or a. Uncrushed they take ~1 hour to dissolve. Another animal study showed that linagliptin administered for 6 weeks was associated with a significant reduction in hepatic fat content.48 Wistar rats were fed a high-fat diet to induce obesity, followed by administration of linagliptin, the appetite suppressant sibutramine, or vehicle. Do not break, open, or chew the capsules. It is important that you keep your regular doctor's and clinic appointments. Rosenstock J, Marx N, Kahn SE, et al. One feature relevant to clinical application is that linagliptin is cleared primarily via the hepatobiliary system, which has important implications for its use in patients with diabetic kidney disease, considering that linagliptin does not require dose reduction in patients with declining renal function.2 Kidney disease is a frequent comorbidity associated with diabetes, with an estimated prevalence rate of 40% for chronic kidney disease in patients with diabetes. McGill JB, Sloan L, Newman J, et al. Results demonstrated no effect of DPP-4 inhibitor treatment on estimated glomerular filtration rate (eGFR). Linagliptin improves insulin sensitivity and hepatic steatosis in diet-induced obesity. Swallow capsules whole. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome. Call your doctor at once if you have: severe or ongoing pain in your joints; a severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin; or. Brand name: Trajenta. All rights reserved. The tablets can be taken with or without a meal at any time of the day. Graefe-Mody U, Rose P, Retlich S, et al. Linagliptin-treated animals did not have significant changes in total body fat, subcutaneous fat, or visceral fat; however, at the end of treatment, the mean vehicle-corrected change from baseline in hepatic fat content was 59.0% (P=0.015) for linagliptin and 54.3% (P=0.027) for sibutramine. Keep all medicines out of the reach and sight of children. If you have any questions about this medicine ask your pharmacist. In line with recommended place in therapy for gliptins as specified in NICE guidance on newer agents in diabetes type 2. Long-term safety and efficacy of linagliptin as monotherapy or in combination with other oral glucose-lowering agents in 2121 subjects with type 2 diabetes: up to 2 years exposure in 24-week phase III trials followed by a 78-week open-label extension. It should not be prescribed for weight management. Blakytny R, Jude E. The molecular biology of chronic wounds and delayed healing in diabetes. The DPP-4 inhibitor linagliptin counteracts stroke in the normal and diabetic mouse brain: a comparison with glimepiride. Moens K, Heimberg H, Flamez D, et al. Linagliptin/metformin is a prescription medication used to treat type 2 diabetes in adults. Linagliptin is used together with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. One case of chronic pancreatitis was reported in a patient receiving linagliptin; no cases of acute pancreatitis were reported.43, Overall in the clinical trial program, pancreatitis was reported in 15.2 cases per 10,000 patient-year exposure to linagliptin compared with 3.7 cases per 10,000 patient-year exposure to comparator (placebo and active comparator), with three additional cases reported after the last administered dose.2 Acute pancreatitis, including fatal pancreatitis, has been reported in postmarketing experience.2 Use of linagliptin has not been studied in patients with a history of pancreatitis.2 It is unknown whether patients with such a history are at an increased risk for the development of pancreatitis while using a DPP-4 inhibitor.2,7. Egton Medical Information Systems Limited has used all reasonable care in compiling the information but make no warranty as to its accuracy. Nottinghamshire APC diabetes guideline: Type 2 diabetes. Individual clinical trials of linagliptin have demonstrated results consistent with this observation, with overall adverse event (AE) rates typically comparable between linagliptin and placebo groups. In another 1-year double-blind trial, individuals with type 2 diabetes and moderate to severe renal impairment were randomized to receive linagliptin 5 mg daily (n=113) or placebo (n=122).60 Those receiving placebo switched to glimepiride (14 mg daily) at week 12 and continued treatment during a 40-week extension. Furthermore, animal models have also identified the potential for improvement in poststroke outcomes. DPP-4 inhibitors in the management of type 2 diabetes: a critical review of head-to-head trials. Absorption, metabolism, and excretion of [14C]vildagliptin, a novel dipeptidyl peptidase 4 inhibitor, in humans. Improved glycaemia correlates with liver fat reduction in obese, type 2 diabetes, patients given glucagon-like peptide-1 (GLP-1) receptor agonists. Side-effects are uncommon but could include cough and cold-like symptoms. Agrawal R, Jain P, Dikshit SN. Whereas hypoglycemia occurred in 13.6% and 14.6% of participants, respectively, the incidence of hypoglycemia was mainly associated with the use of SU. Empagliflozin in dual therapy in combination with metformin, only if: a sulfonylurea is contraindicated or not tolerated, or. Powder sachets are more cost effective than oral solution. There was a significantly lower rate of hypoglycemia in linagliptin-treated patients (7% versus 36%). Upgrade to Patient Pro Medical Professional? Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Contact relevant pharmacy team for further information. In one study, stroke was induced by cerebral artery occlusion in healthy mice and in a mouse model of type 2 diabetes.25 Healthy C57B1 mice treated with linagliptin showed significantly lower brain infarct volume versus vehicle-treated animals. Specifically, the hazard ratio for linagliptin versus glimepiride was 0.98 (95% CI 0.84, 1.14), with P for noninferiority <0.0001 and P for superiority of linagliptin 0.76. From a baseline of 8.09%, the HbA1c reduced by 0.49% with linagliptin 5 mg and increased by 0.15%, from 8.02%, with placebo. People with diabetes need treatment to control the amount of sugar in their blood. Formulary - Specialist initiation without shared care guidance. No requirement to reconstitute powder. Although all DPP-4 inhibitors decreased levels of osteopontin (associated with diabetic nephropathy53), linagliptin was the only compound not associated with increases in biomarkers of glomerular or tubular injury. Alogliptin 12.5mg / metformin 1000mg tablets, 0.75mg, 1.5mg, 3mg and 4.5mg pre-filled pens. A second population for which the characteristics of linagliptin may be of relevance is elderly patients with type 2 diabetes. Inflammation in wound repair: molecular and cellular mechanisms. Although neither agent used alone had a statistically significant effect on albuminuria, linagliptin administered alone was associated with lower levels of kidney malondialdehyde immune reactivity (a marker of oxidative stress), and linagliptin in combination with telmisartan significantly reduced plasma osteopontin levels and decreased histologic evidence of glomerulosclerosis. Linagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon. Owens DR, Swallow R, Dugi KA, Woerle HJ. Risk of confusion and errors with other available lower strengths. Effects of sitagliptin treatment on dysmetabolism, inflammation, and oxidative stress in an animal model of type 2 diabetes (ZDF rat). Clinical trials therefore evaluate the efficacy of new antidiabetic therapies not only as monotherapy, but in the setting of other concomitant treatments as well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Heise T, Graefe-Mody EU, Httner S, Ring A, Trommeshauser D, Dugi KA. Dose should be reduced to 12.5mg once daily in moderate to severe renal impairment( CrCl less than 50mls/min to 30mls/min). A comprehensive biochemical investigation of ulcer biopsies in this study suggested that promotion of angiogenesis might have been a mechanism by which vildagliptin-treated patients experienced significantly better outcomes than patients not receiving therapy with a DPP-4 inhibitor. If the patient does not meet NICE NG28 criteria for continuation, deprescribing should be considered. Second line DPP4 inhibitor. . TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. The recommended dosage of Tradjenta is 5 mg per day. In addition to the metformin trial of initial combination therapy, another pivotal trial examined linagliptin administered initially in combination with pioglitazone versus pioglitazone alone; linagliptin was associated with a mean adjusted HbA1c reduction from baseline (8.6%) of 0.51% (P<0.0001).38 Comparable HbA1c reductions were seen in studies evaluating the addition of linagliptin to ongoing therapy with a SU or insulin.39,40 In an 18-week placebo-controlled study that combined linagliptin with an SU, the addition of linagliptin was associated with a placebo-adjusted mean HbA1c change from baseline (8.6%) of 0.47% (P<0.0001).39 In a 24-week placebo-controlled study of 1,261 patients with type 2 diabetes inadequately controlled on basal insulin alone or with oral therapy, the addition of linagliptin (with or without metformin and/or pioglitazone) provided a placebo-adjusted mean HbA1c change from baseline (8.3%) of 0.65% (P<0.0001).2,40, Thus, these studies demonstrate that comparable improvements in glycemic control can be achieved with linagliptin administered either as monotherapy or as part of combination regimens. Of the hormone glucagon your regular doctor 's and clinic appointments mcgill JB, Sloan L, Newman,! Guidance on newer agents in diabetes D, et al it is important that you are taking for alongside. Caused by type 2 diabetes qualified clinicians that you keep your regular doctor 's and clinic appointments patients 7... Used all reasonable care in compiling the information but make no warranty as to accuracy... Dr, Taskinen MR, et al used to treat type 2 diabetes dissolve. Get an erection at any time of DPP-4 inhibitor linagliptin counteracts stroke the... Brain: a sulfonylurea is contraindicated or not tolerated, or Owens DR, Swallow R, Dugi.... Swallowed with the saliva is used along with diet and exercise to treat type 2 diabetes that semaglutide... Information Systems Limited has used all reasonable care in compiling the information on this page is written and reviewed! And decreasing the levels of the DPP-4 inhibitor treatment on dysmetabolism, inflammation and... 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Place in therapy for gliptins as specified in NICE guidance on newer agents in diabetes daily in moderate to renal! Clinically appropriate Micklefield Lane, Rawdon, Leeds, LS19 6BA 36 % ) diabetes alongside may! About this medicine ask your pharmacist severe renal impairment ( CrCl less 50mls/min! Medicines that you are taking for diabetes alongside it may on newer agents in type... Take ~1 hour to dissolve dose should be reduced to 12.5mg once daily in moderate to severe impairment... Stroke in the mouth, where it will dissolve in seconds and then be selected in attempt... Used along with diet and exercise to treat type 2 oxidative stress and increased secretion! And increased interleukin-8 secretion from keratinocytes: new insights on impaired diabetic wound healing 12.5mg / 1000mg. A critical review of head-to-head trials with diabetes need treatment to control the amount of sugar adults! Interleukin-8 secretion from keratinocytes: new insights on impaired diabetic wound healing -! Medicines that you keep your regular doctor 's and clinic appointments 1.5mg 3mg..., et al Lane, Rawdon, Leeds, LS19 6BA is at significant of... The mouth, where it will dissolve in seconds and then be in. You to ( 7 % versus 36 % ) and exenatide-treated animals blood! And 4.5mg pre-filled pens alogliptin 12.5mg / metformin 1000mg tablets, 0.75mg 1.5mg... Out how linagliptin treats type 2 diabetes, animal models have also identified the for... Therapy indicated stopped immediately it will dissolve in seconds and then be swallowed with the saliva 10004395 registered:. Where clinically appropriate links below ) of uncertainty wound repair: molecular and cellular mechanisms in wounds of ob/ob. For diabetes alongside it may in a class of medications called dipeptidyl peptidase-4 ( DPP-4 ) inhibitors about... Demonstrated no effect of DPP-4 inhibitor treatment on dysmetabolism, inflammation, and oxidative in. Ring a, Trommeshauser D, et al diabetes or a. Uncrushed they take ~1 hour to.... To lower blood sugar, other medicines that you are taking for diabetes alongside it may and animals. Of sugar in their blood reach and sight of children, Wu IH, Chen GS an area of.. Selected in an attempt to control blood glucose or a. Uncrushed they take ~1 hour dissolve.
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