Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naïve adults with Type 2 diabetes
Jazyk angličtina Země Anglie, Velká Británie Médium print-electronic
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
26435365
PubMed Central
PMC5063147
DOI
10.1111/dme.12982
Knihovny.cz E-zdroje
- MeSH
- bifázický inzulin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- diabetes mellitus 2. typu krev farmakoterapie MeSH
- dlouhodobě působící inzulin aplikace a dávkování škodlivé účinky chemie terapeutické užití MeSH
- fixní kombinace léků MeSH
- glykovaný hemoglobin analýza MeSH
- hyperglykemie prevence a kontrola MeSH
- hypoglykemie chemicky indukované epidemiologie patofyziologie prevence a kontrola MeSH
- hypoglykemika aplikace a dávkování škodlivé účinky chemie terapeutické užití MeSH
- inzulin aspart aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- jídla MeSH
- krevní glukóza analýza MeSH
- lidé středního věku MeSH
- lidé MeSH
- monitorování léčiv MeSH
- NPH inzulin aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- riziko MeSH
- rozpustnost MeSH
- rozvrh dávkování léků MeSH
- selfmonitoring glykemie MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- bifázický inzulin MeSH
- dlouhodobě působící inzulin MeSH
- fixní kombinace léků MeSH
- glykovaný hemoglobin MeSH
- hemoglobin A1c protein, human MeSH Prohlížeč
- hypoglykemika MeSH
- insulin aspart, insulin aspart protamine drug combination 30:70 MeSH Prohlížeč
- insulin degludec, insulin aspart drug combination MeSH Prohlížeč
- inzulin aspart MeSH
- krevní glukóza MeSH
- NPH inzulin MeSH
AIM: To evaluate the efficacy and safety of twice-daily insulin degludec/insulin aspart vs. twice-daily biphasic insulin aspart 30 in people with Type 2 diabetes mellitus who were naïve to insulin. METHODS: In this 26-week, multinational, open-label, controlled, two-arm, parallel-group, treat-to-target trial, participants [mean (± sd) age 58.9 (±8.9) years, duration of diabetes 9.5 (±5.9) years, HbA1c 68 (±8.7) mmol/mol or 8.4 (±0.8)% and BMI 31.2 (±4.2) kg/m(2) ) were randomized (1:1) to insulin degludec/insulin aspart (n = 197) or biphasic insulin aspart 30 (n = 197), administered with breakfast and the main evening meal, titrated to a self-monitored plasma glucose target > 3.9 and ≤ 5.0 mmol/l. RESULTS: The mean HbA1c was reduced to 49 mmol/mol (6.6%) with insulin degludec/insulin aspart and 48 mmol/mol (6.5%) with biphasic insulin aspart 30. Insulin degludec/insulin aspart achieved the prespecified non-inferiority margin (estimated treatment difference 0.02%; 95% CI -0.12, 0.17). Insulin degludec/insulin aspart was superior in lowering fasting plasma glucose (estimated treatment difference -1.00 mmol/l; 95% CI -1.4, -0.6; P < 0.001) and reducing overall and nocturnal confirmed hypoglycaemia at a similar overall insulin dose compared with biphasic insulin aspart 30. Similar proportions of participants in each arm experienced severe hypoglycaemia. Adverse events were equally distributed. CONCLUSIONS: Consistent with previous findings, insulin degludec/insulin aspart twice daily effectively improved long-term glycaemic control, with superior reductions in FPG, and significantly less overall and nocturnal confirmed hypoglycaemia compared with biphasic insulin aspart 30 in people with Type 2 diabetes who were insulin-naïve.
Aarhus University Hospital Aarhus Denmark
Clinical Hospital Center Osijek Osijek Croatia
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