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Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial.
Eur J Endocrinol. 2012 Aug; 167(2):287-94.EJ

Abstract

OBJECTIVE

Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of insulin degludec (70%) and insulin aspart (IAsp: 30%). Here, we compare the efficacy and safety of IDegAsp, an alternative IDegAsp formulation (AF: containing 45% IAsp), and biphasic IAsp 30 (BIAsp 30).

DESIGN

Sixteen-week, open-label, randomised, treat-to-target trial.

METHODS

Insulin-naive subjects with type 2 diabetes (18-75 years) and a HbA1c of 7-11% were randomised to twice-daily IDegAsp (n=61), AF (n=59) or BIAsp 30 (n=62), all in combination with metformin. Insulin was administered pre-breakfast and dinner (main evening meal) and titrated to pre-breakfast and pre-dinner plasma glucose (PG) targets of 4.0-6.0 mmol/l.

RESULTS

Mean HbA1c after 16 weeks was comparable for IDegAsp, AF and BIAsp 30 (6.7, 6.6 and 6.7% respectively). With IDegAsp, 67% of subjects achieved HbA1c 7.0% Without confirmed hypoglycaemia in the last 4 weeks of treatment compared with 53% (AF) and 40% (BIAsp 30). Mean fasting PG was significantly lower for IDegAsp vs BIAsp 30 (treatment difference (TD): -0.99 mmol/l (95% confidence interval: -1.68; 0.29)) and AF vs BIAsp 30 (TD: -0.88 mmol/l (-1.58; -0.18)). A significant, 58% lower rate of confirmed hypoglycaemia was found for IDegAsp vs BIAsp 30 (rate ratio (RR): 0.42 (0.23; 0.75)); rates were similar for AF vs BIAsp 30 (RR: 0.92 (0.54; 1.57)). IDegAsp and AF had numerically lower rates of nocturnal confirmed hypoglycaemia vs BIAsp 30 (RR: 0.33 (0.09; 1.14) and 0.66 (0.22; 1.93) respectively).

CONCLUSIONS

IDegAsp provided comparable overall glycaemic control to BIAsp 30 with a significantly lower rate of hypoglycaemia.

Authors+Show Affiliations

Jyväskylä and Medical School, Central Hospital Central Finland, University of Eastern Finland, Kuopio, Finland. leo.niskanen@ksshp.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22660026

Citation

Niskanen, Leo, et al. "Comparison of a Soluble Co-formulation of Insulin Degludec/insulin Aspart Vs Biphasic Insulin Aspart 30 in Type 2 Diabetes: a Randomised Trial." European Journal of Endocrinology, vol. 167, no. 2, 2012, pp. 287-94.
Niskanen L, Leiter LA, Franek E, et al. Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. Eur J Endocrinol. 2012;167(2):287-94.
Niskanen, L., Leiter, L. A., Franek, E., Weng, J., Damci, T., Muñoz-Torres, M., Donnet, J. P., Endahl, L., Skjøth, T. V., & Vaag, A. (2012). Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. European Journal of Endocrinology, 167(2), 287-94. https://doi.org/10.1530/EJE-12-0293
Niskanen L, et al. Comparison of a Soluble Co-formulation of Insulin Degludec/insulin Aspart Vs Biphasic Insulin Aspart 30 in Type 2 Diabetes: a Randomised Trial. Eur J Endocrinol. 2012;167(2):287-94. PubMed PMID: 22660026.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes: a randomised trial. AU - Niskanen,Leo, AU - Leiter,Lawrence A, AU - Franek,Edward, AU - Weng,Jianping, AU - Damci,Taner, AU - Muñoz-Torres,Manuel, AU - Donnet,Jean-Paul, AU - Endahl,Lars, AU - Skjøth,Trine Vang, AU - Vaag,Allan, Y1 - 2012/06/01/ PY - 2012/6/5/entrez PY - 2012/6/5/pubmed PY - 2012/9/27/medline SP - 287 EP - 94 JF - European journal of endocrinology JO - Eur. J. Endocrinol. VL - 167 IS - 2 N2 - OBJECTIVE: Insulin degludec/insulin aspart (IDegAsp) is a soluble co-formulation of insulin degludec (70%) and insulin aspart (IAsp: 30%). Here, we compare the efficacy and safety of IDegAsp, an alternative IDegAsp formulation (AF: containing 45% IAsp), and biphasic IAsp 30 (BIAsp 30). DESIGN: Sixteen-week, open-label, randomised, treat-to-target trial. METHODS: Insulin-naive subjects with type 2 diabetes (18-75 years) and a HbA1c of 7-11% were randomised to twice-daily IDegAsp (n=61), AF (n=59) or BIAsp 30 (n=62), all in combination with metformin. Insulin was administered pre-breakfast and dinner (main evening meal) and titrated to pre-breakfast and pre-dinner plasma glucose (PG) targets of 4.0-6.0 mmol/l. RESULTS: Mean HbA1c after 16 weeks was comparable for IDegAsp, AF and BIAsp 30 (6.7, 6.6 and 6.7% respectively). With IDegAsp, 67% of subjects achieved HbA1c 7.0% Without confirmed hypoglycaemia in the last 4 weeks of treatment compared with 53% (AF) and 40% (BIAsp 30). Mean fasting PG was significantly lower for IDegAsp vs BIAsp 30 (treatment difference (TD): -0.99 mmol/l (95% confidence interval: -1.68; 0.29)) and AF vs BIAsp 30 (TD: -0.88 mmol/l (-1.58; -0.18)). A significant, 58% lower rate of confirmed hypoglycaemia was found for IDegAsp vs BIAsp 30 (rate ratio (RR): 0.42 (0.23; 0.75)); rates were similar for AF vs BIAsp 30 (RR: 0.92 (0.54; 1.57)). IDegAsp and AF had numerically lower rates of nocturnal confirmed hypoglycaemia vs BIAsp 30 (RR: 0.33 (0.09; 1.14) and 0.66 (0.22; 1.93) respectively). CONCLUSIONS: IDegAsp provided comparable overall glycaemic control to BIAsp 30 with a significantly lower rate of hypoglycaemia. SN - 1479-683X UR - https://www.unboundmedicine.com/medline/citation/22660026/Comparison_of_a_soluble_co_formulation_of_insulin_degludec/insulin_aspart_vs_biphasic_insulin_aspart_30_in_type_2_diabetes:_a_randomised_trial_ L2 - https://eje.bioscientifica.com/doi/10.1530/EJE-12-0293 DB - PRIME DP - Unbound Medicine ER -