OBJECTIVE:Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled withonce- or twice-daily (OD or BID) pre- or self-mixed insulin with or without oral antidiabetic drugs. RESEARCH DESIGN AND METHODS: In this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m(2), and HbA1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L. RESULTS: After 26 weeks, mean HbA1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30. CONCLUSIONS: IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once- or twice-daily pre- or self-mixed insulin.
RCT Entities:
OBJECTIVE:Insulin degludec/insulin aspart (IDegAsp) is the first combination of a basal insulin with an ultralong duration of action, and a rapid-acting insulin in a single injection. This trial compared IDegAsp with biphasic insulin aspart 30 (BIAsp 30) in adults with type 2 diabetes inadequately controlled with once- or twice-daily (OD or BID) pre- or self-mixed insulin with or without oral antidiabetic drugs. RESEARCH DESIGN AND METHODS: In this 26-week, randomized, open-label, multinational, treat-to-target trial, participants (mean age 58.7 years, duration of diabetes 13 years, BMI 29.3 kg/m(2), and HbA1c 8.4% [68 mmol/mol]) were exposed (1:1) to BID injections of IDegAsp (n = 224) or BIAsp 30 (n = 222), administered with breakfast and the main evening meal and dose titrated to a self-measured premeal plasma glucose (PG) target of 4.0-5.0 mmol/L. RESULTS: After 26 weeks, mean HbA1c was 7.1% (54 mmol/mol) for both groups, with IDegAsp achieving the prespecified noninferiority margin for mean change in HbA1c (estimated treatment difference [ETD] -0.03% points [95% CI -0.18 to 0.13]). Treatment with IDegAsp was superior in lowering fasting PG (ETD -1.14 mmol/L [95% CI -1.53 to -0.76], P < 0.001) and had a significantly lower final mean daily insulin dose (estimated rate ratio 0.89 [95% CI 0.83-0.96], P = 0.002). Fewer confirmed, nocturnal confirmed, and severe hypoglycemia episodes were reported for IDegAsp compared with BIAsp 30. CONCLUSIONS: IDegAsp BID effectively improves HbA1c and fasting PG levels with fewer hypoglycemia episodes versus BIAsp 30 in patients with uncontrolled type 2 diabetes previously treated with once- or twice-daily pre- or self-mixed insulin.
Authors: Monika Lechleitner; Martin Clodi; Heidemarie Abrahamian; Helmut Brath; Johanna Brix; Heinz Drexel; Peter Fasching; Bernhard Föger; Claudia Francesconi; Elke Fröhlich-Reiterer; Jürgen Harreiter; Sabine E Hofer; Friedrich Hoppichler; Joakim Huber; Susanne Kaser; Alexandra Kautzky-Willer; Bernhard Ludvik; Anton Luger; Julia K Mader; Bernhard Paulweber; Thomas Pieber; Rudolf Prager; Birgit Rami-Merhar; Michael Resl; Michaela Riedl; Michael Roden; Christoph H Saely; Christian Schelkshorn; Guntram Schernthaner; Harald Sourij; Lars Stechemesser; Harald Stingl; Hermann Toplak; Thomas C Wascher; Raimund Weitgasser; Yvonne Winhofer-Stöckl; Sandra Zlamal-Fortunat Journal: Wien Klin Wochenschr Date: 2019-05 Impact factor: 1.704
Authors: C E Onder; S M Kuşkonmaz; G Koc; S Firat; T Omma; I Taskaldiran; P Gokbulut; C Culha Journal: Acta Endocrinol (Buchar) Date: 2020 Oct-Dec Impact factor: 0.877
Authors: Martina Brunner; Thomas Pieber; Stefan Korsatko; Harald Kojzar; Anne Louise Svendsen; Hanne Haahr Journal: Drugs Aging Date: 2015-07 Impact factor: 3.923