Trial reportDiabetes, obesity & metabolism2010
Prandial-basal insulin regimens plus oral antihyperglycaemic agents to improve mealtime glycaemia: initiate and progressively advance insulin therapy in type 2 diabetes.
Trial report in Diabetes, obesity & metabolism, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Efficacy and safety of premixed versus basal-bolus regimens as intensification of insulin therapy in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized clinical trials.Journal of diabetes investigation · 2025Pooled it
- Pooled it
- Pooled it
- Systematic review and meta-analysis of randomized clinical trials comparing efficacy and safety outcomes of insulin glargine with NPH insulin, premixed insulin preparations or with insulin detemir in type 2 diabetes mellitus.Acta diabetologica · 2015Pooled it
- Twenty Years of Insulin Gla-100: A Systematic Evaluation of Its Efficacy and Safety in Type 2 Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022Review
- Efficacy and Safety of Basal Analog Regimens in Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Randomized Controlled Trials.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019Article
- A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Review
- Effects of Insulin Lispro Mix 25 and Insulin Lispro Mix 50 on Postprandial Glucose Excursion in Patients with Type 2 Diabetes: A Prospective, Open-Label, Randomized Clinical Trial.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018Article
- Characteristics of insulin-Naïve people with type 2 diabetes who successfully respond to insulin glargine U100 after 24 weeks of treatment: a meta-analysis of individual participant data from 3 randomized clinical trials.Clinical diabetes and endocrinology · 2018Article
- Use of 50/50 Premixed Insulin Analogs in Type 2 Diabetes: Systematic Review and Clinical Recommendations.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017Review
- Review of basal-plus insulin regimen options for simpler insulin intensification in people with Type 2 diabetes mellitus.Diabetic medicine : a journal of the British Diabetic Association · 2017Review
- Hypoglycemia Event Rates: A Comparison Between Real-World Data and Randomized Controlled Trial Populations in Insulin-Treated Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2016Article
- Clinical considerations for insulin pharmacotherapy in ambulatory care, part two: review of primary literature and an evidence-based approach for treatment.Clinical diabetes : a publication of the American Diabetes Association · 2015Article
- Role of premixed insulin analogues in the treatment of patients with type 2 diabetes mellitus: a narrative review.Journal of diabetes · 2014Review
- Effects of switching from prandial premixed insulin therapy to basal plus two times bolus insulin therapy on glycemic control and quality of life in patients with type 2 diabetes mellitus.Drug design, development and therapy · 2014Observational
- Evidence-based clinical use of insulin premixtures.Diabetology & metabolic syndrome · 2013Article
- Efficacy and safety of biphasic insulin aspart and biphasic insulin lispro mix in patients with type 2 diabetes: A review of the literature.Indian journal of endocrinology and metabolismReview
- High-mix insulins.Indian journal of endocrinology and metabolismArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo compare two progressive approaches [once-daily insulin glargine plus ≤3 mealtime lispro (G+L) vs. insulin lispro mix 50/50 (LM50/50) progression once up to thrice daily (premix progression, PP)] of beginning and advancing insulin in patients with type 2 diabetes (T2D) and inadequate glycaemic control on oral therapy, with the aim of showing non-inferiority of PP to G+L.
methodsPatients were randomized to PP (n = 242) or G+L (n = 242) in a 36-week, multinational, open-label trial. Dinnertime insulin LM 50/50 could be replaced with insulin lispro mix 75/25 if needed for fasting glycaemic control.
resultsBaseline haemoglobin A1c (HbA1c) were 9.5% (PP) and 9.3% (G+L); p = 0.095. Change in A1C (baseline to endpoint) was -1.76% (PP) and -1.93% (G+L) (p = 0.097) [between-group difference of 0.17 (95% confidence interval: -0.03, 0.37)]. Non-inferiority of PP to G+L was not shown based on the prespecified non-inferiority margin of 0.3%. A1C was lower with G+L at weeks 12 (7.8 vs. 7.9%; p = 0.042), 24 (7.4 vs. 7.6%; p = 0.046), but not at week 36 (7.5 vs. 7.6%; p = 0.405). There were no significant differences in percentages of patients achieving A1C ≤7%, overall hypoglycaemia incidence and rate or weight change. Total daily insulin dosages at endpoint were higher with PP vs. G+L (0.57 vs. 0.51 U/kg; p = 0.017), likely due to more injections (1.98 vs. 1.79; p = 0.011).
conclusionsBoth treatments progressively improved glycaemic control in patients with T2D on oral therapy, although non-inferiority of PP to G+L was not shown. Higher insulin doses were observed with PP with no between-treatment differences in overall hypoglycaemia or weight gain.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.