Trial reportDiabetes, obesity & metabolism2014
Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial.
Trial report in Diabetes, obesity & metabolism, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01074268 (NN1250-3585), which is not on this map. Cited by 24 papers, 2 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.
NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- Efficacy and Safety of Once-Weekly and Once-Daily Basal Insulins in Type 1 Diabetes Mellitus: A Systematic Review and Network Meta-Analysis of Clinical Trials.Diabetes, obesity & metabolism · 2026Pooled it
- (Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus.The Cochrane database of systematic reviews · 2021Pooled it
- Pharmacological characteristics of once-weekly insulin icodec in Japanese individuals with type 1 diabetes.Journal of diabetes investigation · 2025Trial
- Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOSTDiabetic medicine : a journal of the British Diabetic Association · 2017Trial
- Attributes Influencing Insulin Pen Preference Among Caregivers and Patients With Diabetes Who Require Greater Than 20 Units of Mealtime Insulin.Journal of diabetes science and technology · 2016Trial
- Insulin degludec in combination with bolus insulin aspart is safe and effective in children and adolescents with type 1 diabetes.Pediatric diabetes · 2015Trial
- Trends in baseline HbA1c and body-mass index in randomised trials of people with type 1 diabetes from 1993 to 2025: an IMI2 SOPHIA systematic review and meta-analysis.EClinicalMedicine · 2025Article
- Insulin Titration Guidelines for Patients With Type 1 Diabetes: It Is About Time!Journal of diabetes science and technology · 2023Review
- Proteomic Changes to the Updated Discovery of Engineered Insulin and Its Analogs: Pros and Cons.Current issues in molecular biology · 2022Review
- Understanding the Clinical Profile of Insulin Degludec, the Latest Basal Insulin Approved for Use in Canada: a Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Review
- Insulin Therapy in Adults with Type 1 Diabetes Mellitus: a Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020 · on this mapReview
- Switching Patients with Type 1 Diabetes to Insulin Degludec from Other Basal Insulins: Real-World Data of Effectiveness and Safety.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020Article
- [Insulin therapy-new insulin analogues].Der Internist · 2019Review
- Reporting of hypoglycaemia in clinical trials of basal insulins: A need for consensus.Diabetes, obesity & metabolism · 2019Review
- Adjustment of insulin doses when switching from glargine 100 U/ml or detemir to degludec: an observational study.Journal of endocrinological investigation · 2019Observational
- Reporting Severe Hypoglycemia in Type 1 Diabetes: Facts and Pitfalls.Current diabetes reports · 2017Review
- A comparison of IDeg + IAsp versus IDet + IAsp in subjects with type 1 diabetes: subgroup analysis of Japanese subjects.Diabetology international · 2016Article
- Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources.Diabetic medicine : a journal of the British Diabetic Association · 2016Article
- Tresiba (Insulin Degludec Injection) and Ryzodeg 70/30 (Insulin Degludec and Insulin Aspart Injection): Two New Insulin Analogs for Glycemic Control in Diabetes Mellitus.American health & drug benefits · 2016Article
- Combination therapies in the management of type 2 diabetes: the use of insulin degludec/liraglutide.Therapeutics and clinical risk management · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe efficacy and safety of insulin degludec (IDeg) was compared with insulin detemir (IDet), both administered once daily (OD) as basal treatment in participants with type 1 diabetes mellitus (T1DM). The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin (HbA1c) reduction after 26 weeks.
methodsThis multinational, 26-week, controlled, open-label, parallel-group trial randomized adults with T1DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart (IAsp). Participants with T1DM treated with any basal-bolus insulin regimen for ≥ 12 months prior to the trial, a mean HbA1c ≤ 10.0% (85.8 mmol/mol) and body mass index (BMI) ≤ 35.0 kg/m(2) at screening participated in the trial (IDeg: N = 302; IDet: N = 153).
resultsAfter 26 weeks, HbA1c decreased 0.73% (8.0 mmol/mol) (IDeg) and 0.65% (7.1 mmol/mol) (IDet) [estimated treatment difference (ETD) IDeg-IDet: -0.09% (-0.23; 0.05)95% CI (-10.0 mmol/mol [-2.6; 0.6]95% CI ); confirming non-inferiority]. Mean fasting plasma glucose improved in both groups, and was lower with IDeg than IDet [ETD IDeg-IDet: -1.66 mmol/l (-2.37; -0.95)95% CI , p < 0.0001]. The rate of confirmed hypoglycaemia was similar with IDeg and IDet [45.83 vs. 45.69 episodes per patient-year of exposure (PYE); estimated rate ratio (RR) IDeg/IDet: 0.98 (0.80; 1.20)95% CI , p = 0.86]. The rate of nocturnal confirmed hypoglycaemia was lower with IDeg than IDet [4.14 vs. 5.93 episodes per PYE; RR IDeg/IDet: 0.66 (0.49; 0.88)95% CI , p = 0.0049]. Adverse event profiles were similar between groups.
conclusionIDeg administered OD in basal-bolus therapy effectively improved long-term glycaemic control in participants with T1DM with a lower risk of nocturnal confirmed hypoglycaemia than IDet.
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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.