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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.
Diabet Med. 2016 Apr; 33(4):497-505.DM

Abstract

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.

Authors+Show Affiliations

Mossakowski Medical Research Centre, Polish Academy of Sciences and Department of Internal Diseases, Endocrinology and Diabetology, Central Clinical Hospital MSW, Warsaw, Poland.Third Department of Medicine, First Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic.Clinical Hospital Center Osijek, Osijek, Croatia.Kartal Training and Research Hospital, Istanbul, Turkey.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Aarhus University Hospital, Aarhus, Denmark.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26435365

Citation

Franek, E, et al. "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." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 33, no. 4, 2016, pp. 497-505.
Franek E, Haluzík M, Canecki Varžić S, et al. 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. Diabet Med. 2016;33(4):497-505.
Franek, E., Haluzík, M., Canecki Varžić, S., Sargin, M., Macura, S., Zacho, J., & Christiansen, J. S. (2016). 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. Diabetic Medicine : a Journal of the British Diabetic Association, 33(4), 497-505. https://doi.org/10.1111/dme.12982
Franek E, et al. 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. Diabet Med. 2016;33(4):497-505. PubMed PMID: 26435365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Franek,E, AU - Haluzík,M, AU - Canecki Varžić,S, AU - Sargin,M, AU - Macura,S, AU - Zacho,J, AU - Christiansen,J S, Y1 - 2015/11/17/ PY - 2015/09/29/accepted PY - 2015/10/6/entrez PY - 2015/10/6/pubmed PY - 2016/12/24/medline SP - 497 EP - 505 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet. Med. VL - 33 IS - 4 N2 - 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. SN - 1464-5491 UR - https://www.unboundmedicine.com/medline/citation/26435365/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_ L2 - https://doi.org/10.1111/dme.12982 DB - PRIME DP - Unbound Medicine ER -