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Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial.
Diabetes Obes Metab. 2016 Mar; 18(3):274-80.DO

Abstract

AIMS

To evaluate the efficacy and safety of two insulin intensification strategies for patients with type 2 diabetes previously treated with basal insulin--insulin degludec (IDeg) and insulin aspart (IAsp)--administered as a co-formulation (IDegAsp) or as a basal-bolus regimen (IDeg and IAsp in separate injections).

METHODS

This 26-week, open-label, treat-to-target, phase IIIb, non-inferiority trial randomized patients (1 : 1) to IDegAsp twice daily with main meals (n = 138; IDegAsp group) or IDeg once daily and IAsp 2-4 times daily (n = 136; IDeg+IAsp group).

RESULTS

After 26 weeks, the mean glycated haemoglobin (HbA1c) level was 7.0% (53 mmol/mol) for the IDegAsp group and 6.8% (51 mmol/mol) for the IDeg+IAsp group (Δ%HbA1c from baseline -1.31 and -1.50%, respectively). The non-inferiority of IDegAsp versus IDeg+IAsp was not confirmed for mean change in HbA1c [estimated treatment difference (ETD) 0.18, 95% confidence interval (CI) -0.04, 0.41; p = non-significant]. No significant differences were observed in the proportion of patients achieving HbA1c <7.0% (56.5 and 59.6%, respectively). IDegAsp treatment resulted in a significantly lower total daily insulin dose, a smaller change in body weight, numerically lower rates of confirmed hypoglycaemia (self-reported plasma glucose <3.1 mmol/l; rate ratio 0.81; p = non-significant), and nocturnal confirmed hypoglycaemic episodes (rate ratio 0.80; p = non-significant) versus IDeg+IAsp. Patient-reported outcome scores for social functioning were significantly higher for IDegAsp versus IDeg+IAsp (ETD 2.2; 95% CI 0.3, 4.1; p < 0.05).

CONCLUSIONS

Both intensification strategies effectively improved glycaemic control. Although non-inferiority was not confirmed, there were no significant differences between the groups that could affect clinical utility.

Authors+Show Affiliations

Endocrine and Metabolic Consultants, Rockville, MD, USA.Department of Endocrinology, l'Institut du Thorax, Nantes University Hospital, Nantes, France.Department of Internal Medicine, Division of Endocrinology and Metabolism, Medical University of Graz, Graz, Austria.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Department of Medicine, Stavanger University Hospital, Stavanger, Norway.

Pub Type(s)

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

Language

eng

PubMed ID

26592732

Citation

Rodbard, H W., et al. "Treatment Intensification With an Insulin Degludec (IDeg)/insulin Aspart (IAsp) Co-formulation Twice Daily Compared With Basal IDeg and Prandial IAsp in Type 2 Diabetes: a Randomized, Controlled Phase III Trial." Diabetes, Obesity & Metabolism, vol. 18, no. 3, 2016, pp. 274-80.
Rodbard HW, Cariou B, Pieber TR, et al. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016;18(3):274-80.
Rodbard, H. W., Cariou, B., Pieber, T. R., Endahl, L. A., Zacho, J., & Cooper, J. G. (2016). Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes, Obesity & Metabolism, 18(3), 274-80. https://doi.org/10.1111/dom.12609
Rodbard HW, et al. Treatment Intensification With an Insulin Degludec (IDeg)/insulin Aspart (IAsp) Co-formulation Twice Daily Compared With Basal IDeg and Prandial IAsp in Type 2 Diabetes: a Randomized, Controlled Phase III Trial. Diabetes Obes Metab. 2016;18(3):274-80. PubMed PMID: 26592732.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. AU - Rodbard,H W, AU - Cariou,B, AU - Pieber,T R, AU - Endahl,L A, AU - Zacho,J, AU - Cooper,J G, Y1 - 2016/01/11/ PY - 2015/08/26/received PY - 2015/11/13/revised PY - 2015/11/16/accepted PY - 2015/11/24/entrez PY - 2015/11/26/pubmed PY - 2016/11/5/medline KW - efficacy KW - insulin aspart KW - insulin degludec KW - insulin intensification KW - type 2 diabetes SP - 274 EP - 80 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 18 IS - 3 N2 - AIMS: To evaluate the efficacy and safety of two insulin intensification strategies for patients with type 2 diabetes previously treated with basal insulin--insulin degludec (IDeg) and insulin aspart (IAsp)--administered as a co-formulation (IDegAsp) or as a basal-bolus regimen (IDeg and IAsp in separate injections). METHODS: This 26-week, open-label, treat-to-target, phase IIIb, non-inferiority trial randomized patients (1 : 1) to IDegAsp twice daily with main meals (n = 138; IDegAsp group) or IDeg once daily and IAsp 2-4 times daily (n = 136; IDeg+IAsp group). RESULTS: After 26 weeks, the mean glycated haemoglobin (HbA1c) level was 7.0% (53 mmol/mol) for the IDegAsp group and 6.8% (51 mmol/mol) for the IDeg+IAsp group (Δ%HbA1c from baseline -1.31 and -1.50%, respectively). The non-inferiority of IDegAsp versus IDeg+IAsp was not confirmed for mean change in HbA1c [estimated treatment difference (ETD) 0.18, 95% confidence interval (CI) -0.04, 0.41; p = non-significant]. No significant differences were observed in the proportion of patients achieving HbA1c <7.0% (56.5 and 59.6%, respectively). IDegAsp treatment resulted in a significantly lower total daily insulin dose, a smaller change in body weight, numerically lower rates of confirmed hypoglycaemia (self-reported plasma glucose <3.1 mmol/l; rate ratio 0.81; p = non-significant), and nocturnal confirmed hypoglycaemic episodes (rate ratio 0.80; p = non-significant) versus IDeg+IAsp. Patient-reported outcome scores for social functioning were significantly higher for IDegAsp versus IDeg+IAsp (ETD 2.2; 95% CI 0.3, 4.1; p < 0.05). CONCLUSIONS: Both intensification strategies effectively improved glycaemic control. Although non-inferiority was not confirmed, there were no significant differences between the groups that could affect clinical utility. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/26592732/Treatment_intensification_with_an_insulin_degludec__IDeg_/insulin_aspart__IAsp__co_formulation_twice_daily_compared_with_basal_IDeg_and_prandial_IAsp_in_type_2_diabetes:_a_randomized_controlled_phase_III_trial_ L2 - https://doi.org/10.1111/dom.12609 DB - PRIME DP - Unbound Medicine ER -