Insulin degludec/insulin aspart (IDegAsp) is a fixed-ratio co-formulation of insulin degludec, which provides long-lasting basal insulin coverage, and insulin aspart, which targets postprandial glycaemia. This review provides expert opinion on the practical clinical use of IDegAsp, including: dose timings relative to meals, when and how to intensify treatment from once-daily (OD) to twice-daily (BID) dose adjustments, and use in special populations (including hospitalized patients). IDegAsp could be considered as one among the choices for initiating insulin treatment, preferential to starting on basal insulin alone, particularly for people with severe hyperglycaemia and/or when postprandial hyperglycaemia is a major concern. The recommended starting dose of IDegAsp is 10 units with the most carbohydrate-rich meal(s), followed by individualized dose adjustments. Insulin doses should be titrated once weekly in two-unit steps, guided by individualized fasting plasma glucose targets and based on patient goals, preferences and hypoglycaemia risk. Options for intensification from IDegAsp OD are discussed, which should be guided by HbA1c, prandial glucose levels, meal patterns and patient preferences. Recommendations for
Purpose
IDegAsp, a co-formulation of long-acting basal (insulin degludec) and rapid-acting bolus (insulin aspart) insulin, provides separate prandial and basal glucose-lowering effects with relatively low risk of hypoglycaemia. Its efficacy and safety have been investigated in a large clinical trial programme (BOOST). We present the rationale and design of the ARISE study, which aims to assess glycaemic control and other clinical parameters associated with IDegAsp use in real world.
Methods
ARISE is a ~26-wk-long, prospective, non-interventional, single-arm study of patients with type 2 diabetes (T2D) initiating IDegAsp treatment. Approximately 1112 patients with T2D aged ≥18 years previously on anti-hyperglycaemic drugs except IDegAsp will be enroled across six countries from 15 Aug 2019 to 12 Nov 2020. IDegAsp treatment will be initiated at the physicians’ discretion and as per the local label. Key exclusion criteria include previous participation, or previous IDegAsp treatment. The primary and secondary endpoints are change in HbA1c from baseline (wk 0) to study end (wk 26–36) and the proportion of patients achieving the target HbA1c level of <7% at the study end, respectively. A mixed model for repeated measurements will analyse the primary endpoint.
Conclusion
Between-country differences in the prescription patterns of glucose-lowering agents in people with T2D warrant examination of their clinical use in different geographical settings. The ARISE study is designed to assess the clinical use of IDegAsp from real world in six different countries. Findings from the ARISE study will supplement those of previous randomised controlled studies by establishing real-world evidence of IDegAsp use in the participating countries.
Trial registration
ClinicalTrials.gov, NCT04042441. Registered 02 August 2014, https://clinicaltrials.gov/ct2/show/NCT04042441
Introduction
Despite the high prevalence of type 2 diabetes (T2D) and suboptimal glycemic control in the Middle East and Africa, comprehensive data on the management of T2D remain scarce. The main aim of this study is to describe the characteristics and treatment of patients with T2D initiating second-line glucose-lowering therapy in these regions.
Methods
DISCOVER is a global, 3-year, prospective observational study of patients with T2D enrolled at initiation of second-line glucose-lowering therapy. Baseline characteristics and treatments are presented for patients from 12 countries divided into three regions: Mediterranean, Gulf Cooperation Council, and South Africa.
Results
Among 3525 patients (52.5% male, mean age 54.3 years), mean time since T2D diagnosis was 6.2 years [across-region range (ARR) 5.8–7.5 years] and mean glycated hemoglobin levels were 8.7% (72.0 mmol/mol) [ARR 8.6–9.0% (68–75 mmol/mol)]. At first line, metformin was prescribed for 88.1% (ARR 85.4–90.3%) of patients and a sulfonylurea for 34.4% (ARR 12.7–45.4%). Sulfonylureas and dipeptidyl peptidase-4 inhibitors were prescribed at second line for 55.5% (ARR 48.6–82.5%) and 49.0% (ARR 3.7–73.8%) of patients, respectively. Main reasons for choice of second-line therapy were efficacy (73.2%; ARR 60.1–77.7%) and tolerability (26.8%; ARR 3.7–31.2%).
Conclusions
We demonstrate considerable inter-region variations in the management of T2D, likely affected by multiple factors (health system, physician behavior, and patient compliance), all of which should be addressed to optimize outcomes.
Supplementary Information
The online version contains supplementary material available at 10.1007/s13300-022-01272-6.
BackgroundWe evaluated the prevalence of vascular complications and associated risk factors in individuals with type 2 diabetes mellitus (T2DM) initiating second-line glucose-lowering therapy from the Middle East and Africa (MEA) cohort of the 3-year prospective DISCOVER study involving 15,992 patients in 38 countries.MethodsBaseline cross-sectional data collected from healthcare settings were used to assess micro and macrovascular complications prevalence as crude and age- and sex-standardised. The multi‐variable analysis assessed factors associated with these complications.ResultsOf 3,525 enrolled patients (mean age: 54.3 ± 10.8 years), >40% had hypertension and hyperlipidaemia. Metformin monotherapy was the first-line therapy in 56.5%, followed by metformin+sulphonylurea (20.3%). Crude and standardised prevalence of microvascular complications were 17.7% and 16.9% (95% confidence interval [CI], 16.77‐16.98) and macrovascular complications were 10.7% and 8.7% (95% CI, 8.59–8.76). Factors significantly (p<0.05) associated with micro and macrovascular complications (odds ratios [95% CI]) were age (1.24 [1.12–1.39] and 1.58 [1.35–1.84]), male sex (1.33 [1.04‐1.70] and 1.71 [1.22–2.40]), hyperlipidaemia (1.33 [1.07-1.65] and 1.96 [1.46-2.63]) and hypertension (1.75 [1.40–2.19] and 2.84 [2.07-3.92]).ConclusionA substantial burden of vascular complications with prominent risk factors in the MEA cohort calls for early preventive interventions.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.