Trial reportDiabetologia2009
Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study.
Trial report in Diabetologia, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00174824 (Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin), which is not on this map. Cited by 38 papers, 4 of them syntheses that pooled it.
What it found
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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.
Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
Who cites it
38 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2020Pooled 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
- Diabetes: glycaemic control in type 2 (drug treatments).BMJ clinical evidence · 2012Pooled it
- Semaglutide, reduction in glycated haemoglobin and the risk of diabetic retinopathy.Diabetes, obesity & metabolism · 2018 · on this mapTrial
- Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks.Diabetes care · 2012Trial
- Trial
- Reduced risk of hypoglycemia with once-daily glargine versus twice-daily NPH and number needed to harm with NPH to demonstrate the risk of one additional hypoglycemic event in type 2 diabetes: Evidence from a long-term controlled trial.Journal of diabetes and its complicationsTrial
- The Silver Jubilee (2025) of Insulin Glargine: Introducing the Era of Long-Acting Insulin Analogues for Diabetes Mellitus.Diabetes, obesity & metabolism · 2026Review
- A FAERS database study on visual impairment adverse events associated with three long-acting insulin analogues.Frontiers in endocrinology · 2026Article
- Insulin Analogs and the Mode of Insulin Delivery: Recent Advances and Challenges.Current pharmaceutical biotechnology · 2025Review
- Protamine as a barrier against the angiogenic effect of insulin: a possible role of apelin.Scientific reports · 2023Article
- Effects of intensive insulin therapy on the retinal microvasculature in patients with type 2 diabetes mellitus: a prospective observational study.BMC ophthalmology · 2022Observational
- Proteomic Changes to the Updated Discovery of Engineered Insulin and Its Analogs: Pros and Cons.Current issues in molecular biology · 2022Review
- A nationwide cohort study for comparative vascular safety of long-acting insulin analogue versus intermediate-acting human insulin in type 2 diabetes.Scientific reports · 2021Article
- The Safety of Pharmacological and Surgical Treatment of Diabetes in Patients with Diabetic Retinopathy-A Review.Journal of clinical medicine · 2021Review
- Worsening of diabetic retinopathy with rapid improvement in systemic glucose control: A review.Diabetes, obesity & metabolism · 2019 · on this mapReview
- Development of a Patient Decision Aid on the Choice of Diabetes Medication for Filipino Patients with Type 2 Diabetes Mellitus.Journal of the ASEAN Federation of Endocrine Societies · 2019Article
- Short-Term Impact of Bariatric Surgery on Best-Corrected Distance Visual Acuity and Diabetic Retinopathy Progression.Obesity surgery · 2018Observational
- 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
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aims/hypothesisThis long-term study was designed to further characterise the retinal safety profile of insulin glargine and human neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes mellitus.
methodsAn open-label, 5 year, randomised (1:1), multicentre, stratified, parallel-group study conducted in the USA and Canada enrolled individuals with type 2 diabetes and either no or non-proliferative retinopathy (less than severe; Early Treatment Diabetic Retinopathy Study [ETDRS] level less than 53 in both eyes) who were treated with oral hypoglycaemic agents (OHAs) alone, insulin alone or OHAs with insulin for >/=3 months prior to study entry and a baseline HbA(1c) level of 6.0-12.0%. Patients were randomised by the investigator according to the centralised interactive voice response system to receive twice-daily NPH insulin (n = 509) or once-daily basal insulin glargine (n = 515). The investigator was not blinded to the treatment group to which each participant had been assigned. The main objective of this study was to compare the progression of diabetic retinopathy between treatment groups by analysing the percentage of patients with three or more step progression in the ETDRS retinopathy patient-level severity scale after treatment with either basal insulin. Masked, centralised grading of seven-field stereoscopic fundus photographs was used.
resultsSimilarly sustained glycaemic control was observed in both the insulin glargine and NPH insulin treatment groups. Despite a slightly greater severity of diabetic retinopathy for the insulin glargine group at baseline, three or more step progression in ETDRS score from baseline to end-of-study was similar between treatment groups (14.2% [53/374] of insulin glargine-treated patients vs 15.7% [57/363] of NPH-treated patients); the difference in the incidence of progression was -1.98% (95% CI -7.02, 3.06%). Other measures of retinopathy-the development of proliferative diabetic retinopathy and progression to clinically significant macular oedema-occurred to a similar degree in both treatment groups. No other safety issues, such as unexpected adverse events for either insulin emerged during the 5 year study. However, NPH insulin treatment was associated with a higher incidence of severe hypoglycaemia compared with insulin glargine. CONCLUSIONS/
interpretationThis study shows no evidence of a greater risk of the development or progression of diabetic retinopathy with insulin glargine vs NPH insulin treatment in patients with type 2 diabetes mellitus.
trial registrationClinicalTrials.gov NCT00174824
fundingThis study was sponsored by sanofi-aventis.
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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.