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A fixed-ratio combination of the basal insulin analogue insulin degludec and the glucagon-like peptide-1 (GLP-1) analogue liraglutide has been developed as a once-daily injection for the treatment of type 2 diabetes. We aimed to compare combined insulin degludec-liraglutide (IDegLira) with its components given alone in insulin-naive patients.In this phase 3, 26-week, open-label, randomised trial, adults with type 2 diabetes, HbA1c of 7-10% (inclusive), a BMI of 40 kg/m(2) or less, and treated with metformin with or without pioglitazone were randomly assigned (2:1:1) to daily injections of IDegLira, insulin degludec, or liraglutide (1·8 mg per day). IDegLira and insulin degludec were titrated to achieve a self-measured prebreakfast plasma glucose concentration of 4-5 mmol/L. The primary endpoint was change in HbA1c after 26 weeks of treatment, and the main objective was to assess the non-inferiority of IDegLira to insulin degludec (with an upper 95% CI margin of 0·3%), and the superiority of IDegLira to liraglutide (with a lower 95% CI margin of 0%). This study is registered with ClinicalTrials.gov, number NCT01336023.1663 adults (mean age 55 years [SD 10], HbA1c 8·3% [0·9], and BMI 31·2 kg/m(2) [4·8]) were randomly assigned, 834 to IDegLira, 414 to insulin degludec, and 415 to liraglutide. After 26 weeks, mean HbA1c had decreased by 1·9% (SD 1·1) to 6·4% (1·0) with IDegLira, by 1·4% (1·0) to 6·9% (1·1) with insulin degludec, and by 1·3% (1·1) to 7·0% (1·2) with liraglutide. IDegLira was non-inferior to insulin degludec (estimated treatment difference -0·47%, 95% CI -0·58 to -0·36, p0·0001) and superior to liraglutide (-0·64%, -0·75 to -0·53, p0·0001). IDegLira was generally well tolerated; fewer participants in the IDegLira group than in the liraglutide group reported gastrointestinal adverse events (nausea 8·8 vs 19·7%), although the insulin degludec group had the fewest participants with gastrointestinal adverse events (nausea 3·6%). We noted no clinically relevant differences between treatments with respect to standard safety assessments, and the safety profile of IDegLira reflected those of its component parts. The number of confirmed hypoglycaemic events per patient year was 1·8 for IDegLira, 0·2 for liraglutide, and 2·6 for insulin degludec. Serious adverse events occurred in 19 (2%) of 825 patients in the IDegLira group, eight (2%) of 412 in the insulin degludec group, and 14 (3%) of 412 in the liraglutide group.IDegLira combines the clinical advantages of basal insulin and GLP-1 receptor agonist treatment, resulting in improved glycaemic control compared with its components given alone.Novo Nordisk.

Background: Clinically effective interventions that could reduce diabetic patients’ risk of long-term complications are needed to contain the rising cost of diabetes care associated with the increasing prevalence of this condition. Good glycaemic control needs to be rapidly attained and maintained by the appropriate initiation and adjustment of glucoselowering therapy. In patients with insulin-requiring type 2 diabetes who are not at goal glycaemia, this translates to the initiation and intensification of insulin therapy. The aim of this study was to evaluate the appropriateness of the initiation of insulin therapy in patients with poorly controlled insulin-requiring type 2 diabetes.Method: This descriptive retrospective study evaluated treatment regimens, dose adjustments and glycated haemoglobin A1c (HbA1c) measurements extracted from records of patients with type 2 diabetes suitable for inclusion. The observation period spanned the 24 months retrospective to study start. Data collected were transcribed into a spreadsheet suitable for statistical analysis.Results: Of the overall cohort of patients with insulin-requiring type 2 diabetes (n = 131), only 45.8% (n = 60) were commenced on insulin during the observation period, of whom 51.7% had subsequent adjustment of insulin dosage. Mean HbA1c at insulin initiation was 10.29% (± 2.42), and 10.63% (± 1.93) after adjustment of insulin dose (p-value > 0.05). Of those who remained on oral glucose-lowering therapy (n = 71), 57.7% had no change in medication dosage throughout the study period. Overall, 81.35% remained ≥ 1% above goal HbA1c by the end of the study period.Conclusion: This study found a discrepancy in the appropriate use and adjustment of insulin therapy according to metabolic status.

Background: Despite improvements in therapy and disease monitoring, diabetic ketoacidosis (DKA) remains a potentially fatal consequence. This retrospective study was undertaken to establish and identify those risk factors that are responsible for the onset of DKA. Methods: The medical records of 77 patients from Addington Hospital, who satisfied the criteria for inclusion into the study of DKA, were reviewed (60 type 1 diabetes mellitus (DM) patients and 17 type 2 DM patients). Results: More juveniles were admitted for multiple DKA episodes (65%) than non-juveniles (35%). DKA occurred in 23% of newly diagnosed type 1 DM on first presentation. Infection was present in 40% of type 1 DM patients with single DKA episodes and in 45% of type 1 DM patients with multiple DKA episodes. A total of 23.2% of all admissions for single DKA involved non-compliance of medication usage and was implicated in 32% of multiple DKA episodes Family and/or school problems presented in 7% of single DKA episodes and 4% in multiple DKA episodes. In the present study, the overall mortality rate was 2.5% (n=2). Conclusion: This study showed that the most important risk factors implicated in DKA were infection, non-compliance and newly diagnosed diabetes, followed by family and/or school problems, low socio-economic status and omission of insulin. South African Family Practice Vol. 49 (10) 2007: pp. 15a-15b