natgillin/translations-raw huggingface dataset:
The benefits and risks of treatment should be carefully considered in patients with acquired generalised LD and/or in patients with significant haematological abnormalities (including leukopenia, neutropenia, bone marrow abnormalities, lymphoma, and/or lymphadenopathy).
Koristi in tveganja zdravljenja je treba skrbno pretehtati pri bolnikih z generalizirano LD in/ali bolnikih s hudimi hematološkimi motnjami (vključno z levkopenijo, nevtropenijo, boleznimi kostnega mozga, limfomom in/ali limfadenopatijo).
Of the 66 generalised LD patients enrolled, 45 (68%) had congenital generalised LD and 21 (32%) had acquired generalised LD.
Med 66 vključenimi bolniki z generalizirano LD jih je 45 (68 %) imelo prirojeno generalizirano LD, 21 (32 %) pa jih je imelo pridobljeno generalizirano LD.
27) Gently use your thumb to push the plunger all the way down.
27) Nežno s palcem potisnite bat do konca navzdol.
2) Before preparing Myalepta solution, allow the powder vial to reach room temperature for about 10 minutes.
2) Pred pripravo raztopine zdravila Myalepta počakajte približno 10 minut, da se viala s praškom segreje na sobno temperaturo.
Very limited data are available for children, especially less than 6 years, with generalised LD.
Za otroke z generalizirano LD, še posebej za mlajše od 6 let, je podatkov zelo malo.
Study NIH 991265/20010769 was conducted over 14 years, with the primary efficacy assessments being made in both generalised LD and partial LD patients after 12 months of treatment.
Študija NIH 991265/20010769 je potekala 14 let, pri čemer so se primarne ocene učinkovitosti izvajale po 12 mesecih zdravljenja tako pri bolnikih z generalizirano LD kot tudi s parcialno LD.
The median age at baseline was 15 years (range: 1-68 years), with 45 (68%) patients being less than 18 years of age.
Povprečna starost je bila 15 let (razpon: 1-68 let), od tega je bilo 45 (68 %) bolnikov mlajših od 18 let.
• 1 U is the same as 0.01 mL.
• 1 U je enako 0,01 ml.
• Until the powder dissolves and the liquid is clear.
• To počnite, dokler se prašek ne raztopi in nastane prozorna tekočina.
• Tap the side of the syringe to move the air pocket/air bubbles to the top of the syringe.
• Potrkajte po strani brizge, da prestavite morebitni zračni žep/zračne mehurčke do vrha brizge.
Neutralising antibodies
Nevtralizirajoča protitelesa
• Hold the bottom of the ampoule in one hand and the top of the ampoule in your other hand.
• Spodnji del ampule primite z eno roko, vrh pa z drugo.
What Myalepta looks like and contents of the pack
Izgled zdravila Myalepta in vsebina pakiranja
The median fasting leptin concentration at baseline was 1.0 ng/mL in males (range: 0.3-3.3 ng/mL) and 1.1 ng/mL in females (range: 0.2-5.3 ng/mL) using the LINCO RIA test method.
Povprečna koncentracija leptina na tešče je bila ob izhodišču 1,0 ng/ml pri moških (razpon: 0,3-3,3 ng/ml) in 1,1 ng/ml pri ženskah (razpon: 0,2-5,3 ng/ml), določeno z uporabo testne metode LINCO RIA.
Myalepta might increase fertility in women with lipodystrophy.
Zdravilo Myalepta lahko poveča plodnost pri ženskah z lipodistrofijo.
Dose adjustments (injection volume)
Prilagoditve odmerka (volumen injekcije)
Other medicines and Myalepta
Druga zdravila in zdravilo Myalepta
The plastic ampoule is a sealed container with a twist-off top.
Plastična ampula je zatesnjen vsebnik z navojnim pokrovčkom.
A review of the patient's self-administration technique is recommended every 6 months whilst using Myalepta.
Pri uporabi zdravila Myalepta se vsakih 6 mesecev priporoča preverjanje bolnikove tehnike samoinjiciranja zdravila.
There are limited data on the pharmacokinetics of metreleptin in patients with lipodystrophy and therefore no formal exposure-response analysis has been performed.
O farmakokinetiki metreleptina pri bolnikih z lipodistrofijo so na voljo samo omejeni podatki, zaradi česar ni bila izvedena formalna analiza razmerja med izpostavljenostjo in odzivom.
For all patients weighing more than 40 kg an incremental adjustment increase in daily dose would be 1.25 mg or 0.25 mL injection volume.
Pri vseh bolnikih, ki tehtajo več kot 40 kg, se dnevni odmerek povečuje v korakih po 1,25 mg ali 0,25 ml injiciranega volumna.
T-cell lymphoma
T-celični limfom
Example: A male patient is initiated at 2.5 mg of Myalepta daily.
Primer: Moški bolnik na začetku prejme 2,5 mg zdravila Myalepta dnevno.
14) Take the needle out of the vial and throw away the syringe into a sharps disposal container.
14) Odstranite iglo iz viale in zavrzite brizgo v vsebnik za ostre predmete.
Patients/carers educational material should contain:
Izobraževalno gradivo za bolnike/skrbnike mora vsebovati:
Patients and/or carers should prepare and administer the first dose of the medicinal product under the supervision of a qualified healthcare professional.
Bolniki in/ali negovalci morajo pripraviti in injicirati prvi odmerek zdravila pod nadzorom kvalificiranega medicinskega strokovnjaka.
• increase in fatty tissue
• povečanje maščobnih tkiv
They will provide a ‘sharps disposal container' for you to put your used vials, syringes and needles in.
Prav tako boste prejeli vsebnik za odstranjevanje ostrih predmetov, v katerega boste odstranjevali rabljene viale, brizge in igle.
In the generalised LD group, the number of patients according to age group was as follows: 5 patients < 6 years (including a single patient < 2 years), 12 patients ≥ 6 to < 12 years and 28 patients aged ≥ 12 to < 18 years; in the partial LD subgroup, there were no patients < 12 years of age and 4 patients ≥ 12 to < 18 years.
V skupini z generalizirano LD je bilo število bolnikov glede na starostno skupino sledeče: 5 bolnikov < 6 let (vključno z enim bolnikom < 2 leti), 12 bolnikov ≤ 6 do < 12 let in 28 bolnikov, starih ≤ 12 do
• a higher than normal desire for food or excessive eating
• večja želja po hrani kot običajno ali prekomerno prehranjevanje • hitrejši srčni utrip od običajnega
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Myalepta should be permanently discontinued immediately and appropriate therapy initiated.
Če pride do anafilaktične reakcije ali druge resne alergijske reakcije, je treba z dajanjem zdravila Myalepta takoj trajno prenehati in uvesti ustrezno zdravljenje.
• The 0.3 mL syringe shows the injection amount in ‘U' instead of ‘mL'.
• Na 0,3-mililitrski brizgi je količina za injiciranje prikazana v "U" namesto v "ml".
The European Medicines Agency has deferred the obligation to submit the results of studies with Myalepta in one or more subsets of the paediatric population in the treatment of lipodystrophy (see section 4.2 for information on paediatric use).
Myalepta za eno ali več podskupin pediatrične populacije pri zdravljenju lipodistrofije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The needle will now be facing up.
Igla bo sedaj usmerjena navzgor.
If you notice any of the symptoms above, or you are not sure, talk to your doctor straight away.
Če opazite katere od zgornjih simptomov oz. niste prepričani, se takoj posvetujte z zdravnikom.
If an anaphylactic reaction or other serious allergic reaction occurs, administration should be permanently discontinued immediately and appropriate therapy initiated.
Če pride do anafilaktične reakcije ali druge resne alergijske reakcije, je treba takoj prenehati z dajanjem zdravila in uvesti ustrezno terapijo.
0.3 mL U100 Insulin Syringe
0,3 ml insulinska brizga U100
• Without the needle attached, insert the 1 mL syringe tip into the top of the plastic ampoule as far as possible.
• Brez pritrjene igle vstavite konico 1-mililitrske brizge čim dlje v vrh plastične ampule.
Attach the needle to the syringe.
Pritrdite iglo na brizgo.
Myalepta is not recommended during pregnancy and in women of childbearing potential not using contraception.
Zdravila Myalepta ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Symptoms of high blood sugar levels include:
Simptomi visokih ravni krvnega sladkorja vključujejo:
TGs for the generalised LD group were noted in all age groups with larger mean changes observed in the older age group (-42.9%) compared to the younger age groups (-10.5% and -14.1%).
Povprečna zmanjšanja od izhodišča do 12 mesecev/LOCF v ravni TG v skupini z generalizirano LD so bila zabeležena pri vseh starostnih skupinah, večje povprečne spremembe pa so bile opazne pri starejši starostni skupini (-42,9 %) v primerjavi z mlajšima starostnima skupinama (-10,5 % in -14,1 %).
- Patients and/or caregivers should prepare and administer the first dose under the supervision of a qualified HCP.
- Bolniki in/ali skrbniki morajo pripraviti in dati prvi odmerek pod nadzorom usposobljenega zdravstvenega delavca.
Read the “Instructions for Use” (see section 7) for how to make the solution before injecting.
V " priročniku za uporabo" (glejte 7. poglavje) je opisano, kako pripraviti raztopino pred injiciranjem.
How to store Myalepta 6.
Shranjevanje zdravila Myalepta 6.
Patients were eligible for inclusion if they were > 6 months old, with a leptin level of < 12 ng/mL, and had at least 1 of the following 3 metabolic abnormalities:
> 6 mesecev, so imeli raven leptina < 12 ng/ml in so imeli vsaj 1 od naslednjih 3 presnovnih nepravilnosti:
• medicines for epilepsy or fits (such as phenytoin)
• zdravila za zdravljenje epilepsije ali napadov krčev (kot je fenitoin);
− A starting dose is 0.06 mg (0.012 mL of solution) for each kilogram of body weight.
− začetni odmerek je 0,06 mg (0,012 ml raztopine) za vsak kilogram telesne mase,
Action
Dejanje
Safety and efficacy data were analysed in a subgroup of partial LD patients with the following characteristics: 12 years of age and above with leptin levels < 12 ng/mL, TG ≥ 5.65 mmol/l and/or
Podatki o varnosti in učinkovitosti so bili analizirani v podskupini bolnikov s parcialno LD z naslednjimi značilnostmi: starostjo 12 let ali več in ravnmi leptina < 12 ng/ml, TG ≥ 5,65 mmol/l in/ali HbA1c ≥ 8 %.
• If your dose is 1.50 mg (0.30 mL of solution) or less, you will need to use a 0.3 mL syringe.
• Če je vaš odmerek 1,50 mg (0,30 ml raztopine) ali manj, morate uporabiti 0,3-mililitrsko brizgo.
• Hold the ampoule so that the top is facing up.
• Ampulo držite tako, da bo vrh usmerjen navzgor.
You may have higher amounts of sugar (‘hyper-glycaemia') or fat (‘hyper-triglyceridaemia') in your blood while on Myalepta, which may be a sign that this medicine is not working as well as it should.
ali maščob ("hipertrigliceridemija") v krvi, kar je lahko znak, da zdravilo ne deluje tako dobro, kot bi moralo.
Once insulin requirements have stabilised, dose adjustments of other anti-diabetics may also be needed in some patients.
Ko se potreba po insulinu stabilizira, bo pri nekaterih bolnikih morda treba prilagoditi tudi druge antidiabetike.
Do not reconstitute with other diluents.
Ne redčite z drugimi topili.
Actual body weight at initiation of treatment should always be used when calculating the dose.
Pri izračunu odmerka je treba vedno uporabiti bolnikovo telesno maso na začetku zdravljenja.
Non-compliance with, or abrupt discontinuation of, Myalepta may result in worsening hypertriglyceridaemia and associated pancreatitis, particularly in patients with risk factors for pancreatitis (e.g. history of pancreatitis, severe hypertriglyceridaemia) (see section 4.8).
Nepravilno zdravljenje ali nenadna prekinitev jemanja zdravila Myalepta lahko povzroči poslabšanje hipertrigliceridemije in povezanega pankreatitisa, predvsem pri bolnikih z dejavniki tveganja za pankreatitis (npr. anamneza pankreatitisa, huda hipertrigliceridemija) (glejte poglavje 4.8).
• The other ingredients are: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment).
• Druge sestavine zdravila so: glicin, saharoza, polisorbat 20, glutaminska kislina, natrijev hidroksid (za uravnavanje pH).
7) Remove any air pocket or air bubbles.
7) Odstranite morebitne zračne žepe in zračne mehurčke.
The water for injection will come in either:
Voda za injekcije je lahko v:
Fatigue, Injection site bruising, Injection site erythema, Injection site reaction
Utrujenost, podplutba na mestu injiciranja, eritem na mestu injiciranja, reakcija na mestu injiciranja
• Remove the syringe from the ampoule and hold it so that the needle faces up.
• Odstranite brizgo iz ampule in jo primite tako, da bo igla usmerjena navzgor.
• Do not insert the needle into a muscle.
• Ne vstavite igle v mišico.
Maximum daily dose (injection volume)
Največji dnevni odmerek (volumen injekcije)
• feeling sleepy or confused
• občutek zaspanosti ali zmedenosti
Fat tissue increased, Injection site haemorrhage, Injection site pain, Injection site pruritus, Injection site swelling, Malaise, Peripheral swelling
Povečanje maščobnega tkiva, krvavitev na mestu injiciranja, bolečina na mestu injiciranja, srbenje na mestu injiciranja, oteklina na mestu injiciranja, splošno slabo počutje, periferno otekanje
For the 32 patients with generalised LD who were receiving oral anti-diabetic medicinal products at baseline, 7 (22%) were able to discontinue their use.
Med 32 bolniki z generalizirano LD, ki so ob izhodišču prejemali peroralne antidiabetike, jih je lahko 7 (22 %) prenehalo z jemanjem le-teh.
• With the syringe still inserted into the glass vial or plastic ampoule, tap the side of the syringe to move the air pocket/air bubbles to the top of the syringe.
• Z brizgo še vedno v stekleni viali ali plastični ampuli potrkajte po strani brizge, da prestavite morebitni zračni žep in/ali zračne mehurčke do vrha brizge.
• feeling more sleepy
• občutek večje zaspanosti
Initiating or adjusting lipid lowering medications may be required.
Po potrebi je treba uvesti ali prilagoditi odmerek zdravila za zniževanje ravni lipidov.
For the 18 patients with baseline body weight less than or equal to 40 kg, the weighted average daily dose was 2.0 mg for males and 2.3 mg for females in the first year of treatment, and 2.5 mg for males and 3.2 mg for females over the entire study period.
Pri 18 bolnikih z izhodiščno telesno težo manjšo ali enako 40 kg je bil utežen povprečni dnevni odmerek 2,0 mg za moške in 2,3 mg za ženske v prvem letu zdravljenja ter 2,5 mg za moške in 3,2 mg za ženske za celotno obdobje študije.
The reconstituted solution should be injected into the abdomen, thigh or upper arm tissue.
Rekonstituirano raztopino je treba injicirati v tkivo na trebuhu, stegnu ali nadlahti.
Change from Baseline at Month 12
Spremembe od osnove po 12 mesecih
This is the same as 0.05 mL.
To je enako 0,05 ml.
Table 3 Required syringe for Myalepta reconstitution with water for injection Syringe
Preglednica 3 Potrebna brizga za rekonstitucijo zdravila Myalepta z vodo za injekcije Brizga
Unused reconstituted solution should be discarded after use.
Neporabljeno rekonstituirano raztopino je treba po uporabi zavreči.
If you use more Myalepta than you should, talk to your doctor or go to a hospital straight away.
Če ste uporabili večji odmerek zdravila Myalepta, kot bi smeli Če ste vzeli večji odmerek zdravila Myalepta, kot bi smeli, se posvetujte s svojim zdravnikom ali pa takoj pojdite v bolnišnico.
o Responsibility of the prescribing physician to provide appropriate training to the patient/carer who will administer the treatment and that the first dose should be administered in the presence of a doctor or nurse.
o Zdravnik, ki predpiše zdravilo Myalepta, je odgovoren za ustrezno usposabljanje bolnika/skrbnika, ki bo dajal zdravilo, in za dajanje prvega odmerka v prisotnosti zdravnika ali medicinske sestre.
• Without the needle attached, insert the 3 mL syringe tip into the top of the plastic ampoule as far as possible.
• Brez pritrjene igle vstavite konico 3-mililitrske brizge čim dlje v vrh plastične ampule.
Remaining solution should be discarded after use.
Ostanek raztopine je treba po uporabi zavreči.
Using the glass ampoule
Uporaba steklene ampule
• Do not dissolve another dose of Myalepta powder with any ampoule or vial containing unused remaining water for injection.
• Ne raztapljajte naslednjega odmerka praška zdravila Myalepta s katero koli ampulo ali vialo, v kateri je še ostanek vode za injekcije.
17) Insert the needle through the centre of the rubber bung, all the way into the vial containing the dissolved Myalepta solution.
17) Iglo vstavite skozi sredino gumijastega čepa do konca v vialo, ki vsebuje raztopljeno raztopino zdravila Myalepta.
Signs and/or symptoms consistent with pancreatitis should prompt an appropriate clinical evaluation (see section 4.4).
Ob pojavu znakov in/ali simptomov pankreatitisa je treba izvesti ustrezen klinični pregled (glejte poglavje 4.4).
• Place the vial on a flat, hard surface.
• Vialo postavite na trdno, ravno površino.
However, you may be at higher risk of getting a lymphoma when using the medicinal product.
Vendar pa je tveganje, da zbolite za limfomom, večje, če jemljete to zdravilo.
Always use a new ampoule or vial of water for injection.
uporabite novo ampulo ali vialo vode za injekcije.
• swelling or bleeding under the skin, where you injected
• otekanje ali krvavitev pod kožo na mestu injiciranja
Myalepta is used to treat the complications of not having enough leptin in patients with lipodystrophy.
Zdravila Myalepta se uporablja za zdravljenje zapletov, kadar bolniki z lipodistrofijo nimajo dovolj leptina.
16) To inject the Myalepta solution, you will use a new injection syringe, which will either be the 0.3 mL, 1.0 mL, or 2.5 mL syringe that was provided to you by your doctor, nurse or pharmacist.
16) Za injekcije raztopine zdravila Myalepta boste uporabili novo brizgo, ki bo ali 0,3-, 1,0- ali 2,5-mililitrska, dobili pa jo boste pri zdravniku, medicinski sestri ali farmacevtu.
With the needle still in the ampoule, pull the plunger up carefully.
Z iglo še vedno v ampuli previdno povlecite bat navzgor.
The adverse reactions reported in generalised LD and this subgroup of partial LD patients are listed in Table 7.
Neželeni učinki, poročani pri bolnikih z generalizirano LD in to podskupino s parcialno LD, so našteti v tabeli 7.
No formal metabolism studies have been conducted.
Formalne študije presnove niso bile izvedene.
While the impact of neutralising antibodies on efficacy has not been confirmed, consideration should be given by the prescriber to have patients tested for the presence of neutralising antibodies if there is significant loss of efficacy despite Myalepta administration.
Čeprav vpliv nevtralizirajočih protiteles na učinkovitost ni bil potrjen, naj v primeru znatnega zmanjšanja učinkovitosti kljub uporabi zdravila Myalepta, zdravnik, ki predpiše zdravilo presodi, ali naj bolniki opravijo test za prisotnost nevtralizirajočih protiteles.
Closely monitor blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogues and combination treatment.
Pozorno spremljajte glukozo v krvi pri bolnikih, ki sočasno prejemajo insulin, predvsem pri tistih z visokimi odmerki, ali tistih, ki jemljejo insulinske sekretagoge oz. kombinacijo zdravil.
A blocking activity of the reaction between metreleptin and a recombinant leptin receptor has been observed in vitro in the blood of the majority of an extended set of patients (98 out of 102 patients or 96%) but the impact on the efficacy of metreleptin could not be clearly established.
Zaviralna aktivnost reakcije med metreleptinom in receptorjem za rekombinantni leptin je bila ugotovljena in vitro v krvi večine bolnikov iz razširjenega nabora (98 od 102 bolnikov ali 96 %),
Excipients: glycine, sucrose, polysorbate 20, glutamic acid, sodium hydroxide (for pH adjustment)
Pomožne snovi: glicin, saharoza, polisorbat 20, glutaminska kislina, natrijev hidroksid (za uravnavanje pH)
Cough, Dyspnoea Pleural effusion
Kašelj, dispneja, plevralni izliv
• The top rim of the plunger should line up with the black line on the syringe that matches the amount of Myalepta solution you are going to inject.
• Zgornji rob bata se mora poravnati s črno črto na brizgi, ki ustreza količini raztopine zdravila
Unused reconstituted solution cannot be stored for later use.
Neuporabljene razredčene raztopine ni dovoljeno hraniti za poznejšo uporabo.
6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 1 mL syringe.
6) Ne glede na to, ali vodo za injekcije uporabljate iz viale ali ampule, morate vedno preveriti, ali imate v svoji 1-mililitrski brizgi zračne mehurčke ali zračne žepe.
o Non-compliance with or abrupt withdrawal of Myalepta may result in worsening of hypertriglyceridaemia and associated pancreatitis: - Risk factors include patients with a history of pancreatitis or severe hypertriglyceridaemia.
Myalepta lahko povzroči poslabšanje hipertrigliceridemije in povezanega pankreatitisa: - Dejavniki tveganja vključujejo bolnike z anamnezo pankreatitisa ali hude hipertrigliceridemije.
Once insulin requirements have stabilised, dose adjustments of other anti-diabetics may also be needed in some patients to minimise the risk of hypoglycaemia.
Ko se potrebna količina insulina stabilizira, bo pri nekaterih bolnikih treba prilagoditi tudi druge antidiabetike, da zmanjšate tveganje hipoglikemije.
The safety and efficacy of metreleptin in children aged 0 to 2 years with generalised LD and children aged 0 to 12 years with partial LD has not been established.
Pediatrična populacija Varnost in učinkovitost metreleptina pri otrocih, starih 0 do 2 leti, z generalizirano LD, in otrocih,
6) No matter whether you have withdrawn water for injection from a vial or ampoule, you must check for air pockets or air bubbles in your 3 mL syringe.
6) Ne glede na to, ali vodo za injekcije uporabljate iz viale ali ampule, morate vedno preveriti, ali imate v svoji 3-mililitrski brizgi zračne mehurčke ali zračne žepe.
Remove the needle cover.
Odstranite pokrovček igle.
Myalepta is presented as a powder for solution for injection (powder for injection).
Zdravilo Myalepta je na voljo kot prašek za raztopino za injiciranje (powder for injection).
In order to further investigate the effect of Myalepta on poor metabolic control once background therapy is maximized in patients with familial or acquired partial LD, the applicant should conduct an efficacy and safety study according to an agreed protocol.
Myalepta na slabo presnovno urejenost, ko se pri bolnikih s familiarno ali pridobljeno parcialno LD osnovno zdravljenje maksimizira, mora predlagatelj izvesti študijo o učinkovitosti in varnosti v skladu z dogovorjenim protokolom.
Unplanned pregnancies may occur due to restoration of luteinizing hormone (LH) release, see section
Nosečnost Zaradi obnove sproščanja luteinizirajočega hormona (LH) se lahko pojavi nenačrtovana nosečnost;
Remove the needle and syringe from the vial and gently swirl the contents to reconstitute, until the liquid is clear.
Izvlecite iglo in brizgo iz viale in nežno vrtinčite vsebino, da se razredči in dobite prozorno tekočino.
Doses exceeding 1 mL can be administered as two injections (the total daily dose divided equally) to minimise potential injection site discomfort due to injection volume.
Odmerke, ki presegajo 1 ml, je mogoče injicirati v dveh injekcijah (dnevni odmerek razdelite na enaka odmerka),
Dose adjustments in children without metabolic abnormalities should primarily be made according to weight change.
Odmerke pri otrocih brez presnovnih nepravilnosti je treba prilagajati glede na spremembo telesne mase.
The Myalepta powder is dissolved by mixing it with water for injections to make the solution for injecting.
Prašek zdravila Myalepta je treba raztopiti, tako da ga zmešate z vodo za injekcije in dobite raztopino za injiciranje.
• Do not remove the rubber seal.
• Ne odstranite gumijastega tesnila.
Among 18 patients in the partial LD subgroup who had a baseline HbA1c level 8% or greater and data available at Month 12, the mean (SD) baseline HbA1c level was 9.9% (1.59) and the mean reduction in HbA1c at Month 12 was 1.3%.
Med 18 bolniki v podskupini s parcialno LD, ki so imeli izhodiščno raven HbA1c 8-odstotno ali več in po 12 mesecih razpoložljive podatke, je bila povprečna (SD) izhodiščna raven HbA1c 9,9 % (1,59), povprečno odstotno zmanjšanje HbA1c po 12 mesecih pa je bilo 1,3-odstotno.