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The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes.
Diabetes Obes Metab. 2018 07; 20(7):1585-1592.DO

Abstract

AIMS

To investigate whether the proven benefits of insulin degludec (IDeg) combined with insulin aspart (IAsp), known as IDegAsp, given twice daily, extend across a wide spectrum of patients with diabetes.

MATERIALS AND METHODS

This was a post hoc pooled analysis of 5 phase III randomized, 26-week, open-label, treat-to-target trials comparing IDegAsp twice daily (n = 1111) with one of two comparators: premixed insulin (biphasic insulin aspart 30 [BIAsp 30]) twice daily (n = 561) or IDeg once daily + IAsp (n = 136). Patient data were stratified according to baseline glycated haemoglobin (HbA1c) or fasting plasma glucose (FPG) categories, as well as by baseline duration of diabetes or body mass index (BMI) categories.

RESULTS

We conducted a meta-analysis of 5 clinical trials: NCT01513590, NCT01009580, NCT01059812, NCT01680341 and NCT01713530. End-of-trial results were broadly consistent, with differences between IDegAsp and comparators observed in phase III trials. HbA1c results were similar for IDegAsp and the comparators in all baseline characteristic (HbA1c, duration of diabetes or BMI) and category groups (number ranges). Significantly lower FPG level was observed with IDegAsp vs comparators in all baseline characteristic and most category groups (excluding FPG <5.5 mmol/L). Significantly lower insulin doses were observed with IDegAsp vs comparators in all baseline characteristic and half of the category groups, and significantly lower rates of confirmed and nocturnal confirmed hypoglycaemia were observed with IDegAsp vs comparators in all baseline variable and category groups.

CONCLUSIONS

IDegAsp retains a consistent safety and efficacy profile in patients with different baseline characteristics.

Authors+Show Affiliations

Institute for Clinical and Experimental Medicine and Charles University, Prague, Czech Republic.Royal North Shore Hospital, University of Sydney, Sydney, Australia.Medical University of Graz, Graz, Austria.Novo Nordisk A/S, Søborg, Denmark.Novo Nordisk A/S, Søborg, Denmark.Endocrine and Metabolic Consultants, Rockville, Maryland.

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29451706

Citation

Haluzík, Martin, et al. "The Co-formulation of Insulin Degludec and Insulin Aspart Lowers Fasting Plasma Glucose and Rates of Confirmed and Nocturnal Hypoglycaemia, Independent of Baseline Glycated Haemoglobin Levels, Disease Duration or Body Mass Index: a Pooled Meta-analysis of Phase III Studies in Patients With Type 2 Diabetes." Diabetes, Obesity & Metabolism, vol. 20, no. 7, 2018, pp. 1585-1592.
Haluzík M, Fulcher G, Pieber TR, et al. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018;20(7):1585-1592.
Haluzík, M., Fulcher, G., Pieber, T. R., Bardtrum, L., Tutkunkardas, D., & Rodbard, H. W. (2018). The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes, Obesity & Metabolism, 20(7), 1585-1592. https://doi.org/10.1111/dom.13261
Haluzík M, et al. The Co-formulation of Insulin Degludec and Insulin Aspart Lowers Fasting Plasma Glucose and Rates of Confirmed and Nocturnal Hypoglycaemia, Independent of Baseline Glycated Haemoglobin Levels, Disease Duration or Body Mass Index: a Pooled Meta-analysis of Phase III Studies in Patients With Type 2 Diabetes. Diabetes Obes Metab. 2018;20(7):1585-1592. PubMed PMID: 29451706.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. AU - Haluzík,Martin, AU - Fulcher,Greg, AU - Pieber,Thomas R, AU - Bardtrum,Lars, AU - Tutkunkardas,Deniz, AU - Rodbard,Helena W, Y1 - 2018/03/25/ PY - 2017/11/30/received PY - 2018/02/09/revised PY - 2018/02/12/accepted PY - 2018/2/17/pubmed PY - 2018/12/18/medline PY - 2018/2/17/entrez KW - glycaemic control KW - hypoglycaemia KW - insulin analogues KW - meta-analysis KW - randomized trial KW - type 2 diabetes SP - 1585 EP - 1592 JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab VL - 20 IS - 7 N2 - AIMS: To investigate whether the proven benefits of insulin degludec (IDeg) combined with insulin aspart (IAsp), known as IDegAsp, given twice daily, extend across a wide spectrum of patients with diabetes. MATERIALS AND METHODS: This was a post hoc pooled analysis of 5 phase III randomized, 26-week, open-label, treat-to-target trials comparing IDegAsp twice daily (n = 1111) with one of two comparators: premixed insulin (biphasic insulin aspart 30 [BIAsp 30]) twice daily (n = 561) or IDeg once daily + IAsp (n = 136). Patient data were stratified according to baseline glycated haemoglobin (HbA1c) or fasting plasma glucose (FPG) categories, as well as by baseline duration of diabetes or body mass index (BMI) categories. RESULTS: We conducted a meta-analysis of 5 clinical trials: NCT01513590, NCT01009580, NCT01059812, NCT01680341 and NCT01713530. End-of-trial results were broadly consistent, with differences between IDegAsp and comparators observed in phase III trials. HbA1c results were similar for IDegAsp and the comparators in all baseline characteristic (HbA1c, duration of diabetes or BMI) and category groups (number ranges). Significantly lower FPG level was observed with IDegAsp vs comparators in all baseline characteristic and most category groups (excluding FPG <5.5 mmol/L). Significantly lower insulin doses were observed with IDegAsp vs comparators in all baseline characteristic and half of the category groups, and significantly lower rates of confirmed and nocturnal confirmed hypoglycaemia were observed with IDegAsp vs comparators in all baseline variable and category groups. CONCLUSIONS: IDegAsp retains a consistent safety and efficacy profile in patients with different baseline characteristics. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/29451706/The_co_formulation_of_insulin_degludec_and_insulin_aspart_lowers_fasting_plasma_glucose_and_rates_of_confirmed_and_nocturnal_hypoglycaemia_independent_of_baseline_glycated_haemoglobin_levels_disease_duration_or_body_mass_index:_A_pooled_meta_analysis_of_phase_III_studies_in_patients_with_type_2_diabetes_ L2 - https://doi.org/10.1111/dom.13261 DB - PRIME DP - Unbound Medicine ER -