Trial reportDiabetes care2012
Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial.
Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00978627 (NN5401-3594), which is not on this map. Cited by 36 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.
NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)
Who cites it
36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.
- Efficacy and safety among second-generation and other basal insulins in adult patients with type 1 diabetes: a systematic review and network meta-analysis.Naunyn-Schmiedeberg's archives of pharmacology · 2021Pooled it
- (Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus.The Cochrane database of systematic reviews · 2021Pooled it
- 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
- Medium-term effects of insulin degludec on patients with type 1 diabetes mellitus.Drugs in R&D · 2014Trial
- 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 Analogs and the Mode of Insulin Delivery: Recent Advances and Challenges.Current pharmaceutical biotechnology · 2025Review
- Practical guide in using insulin degludec/insulin aspart: A multidisciplinary approach in Malaysia.Malaysian family physician : the official journal of the Academy of Family Physicians of Malaysia · 2023Article
- Proteomic Changes to the Updated Discovery of Engineered Insulin and Its Analogs: Pros and Cons.Current issues in molecular biology · 2022Review
- Intensification of Insulin Treatment With Insulin Degludec/Aspart in Type 2 Diabetic Patients: A 2-Year Real-World Experience.Frontiers in clinical diabetes and healthcare · 2022Article
- Safety of Insulin Degludec/Insulin Aspart in Patients with Diabetes Mellitus over a Period of 1 Year during Routine Clinical Care in India: SMART (Study of Management of Diabetes with Ryzodeg™ Treatment).Medical sciences (Basel, Switzerland) · 2021Article
- Use of Insulin Degludec/Insulin Aspart in the Management of Diabetes Mellitus: Expert Panel Recommendations on Appropriate Practice Patterns.Frontiers in endocrinology · 2021Review
- Practical use of insulin degludec/insulin aspart in a multinational setting: beyond the guidelines.Diabetes, obesity & metabolism · 2020Review
- The Evolution of Insulin and How it Informs Therapy and Treatment Choices.Endocrine reviews · 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
- Factors Influencing Variations in Hospitalization for Diabetes with Hypoglycemia.Journal of clinical medicine · 2018Article
- Reporting Severe Hypoglycemia in Type 1 Diabetes: Facts and Pitfalls.Current diabetes reports · 2017Review
- Insulin degludec is associated with less frequent and milder hypoglycemia in insulin-deficient patients with type 1 diabetes compared with insulin glargine or detemir.Diabetology international · 2017Article
- A Review of Insulin Degludec/Insulin Aspart: Pharmacokinetic and Pharmacodynamic Properties and Their Implications in Clinical Use.Clinical pharmacokinetics · 2017Review
- United States experience of insulin degludec alone or in combination for type 1 and type 2 diabetes.Drug design, development and therapy · 2017Review
- A comparison of IDeg + IAsp versus IDet + IAsp in subjects with type 1 diabetes: subgroup analysis of Japanese subjects.Diabetology international · 2016Article
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 8 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate efficacy and tolerability of a co-formulation of insulin degludec and insulin aspart (IDegAsp) with insulin aspart (IAsp) at other meals compared with basal-bolus therapy using insulin detemir (IDet) and IAsp. RESEARCH DESIGN AND
methodsAdults (n = 548) with type 1 diabetes (A1C 7.0-10.0%; BMI ≤35.0 kg/m(2)) were randomized 2:1 in a 26-week, multinational, parallel-group, treat-to-target trial to IDegAsp or IDet. IDegAsp was given with a meal, and IDet was given in the evening, with a second (breakfast) dose added if needed.
resultsNon-inferiority for IDegAsp versus IDet was confirmed; A1C improved by 0.75% with IDegAsp and 0.70% with IDet to 7.6% in both groups (estimated treatment difference IDegAsp - IDet: -0.05% [95% CI -0.18 to 0.08]). There was no statistically significant difference between IDegAsp and IDet in the rates of severe hypoglycemia (0.33 and 0.42 episodes/patient-year, respectively) or overall confirmed (plasma glucose <3.1 mmol/L) hypoglycemia (39.17 and 44.34 episodes/patient-year, respectively). Nocturnal confirmed hypoglycemia rate was 37% lower with IDegAsp than IDet (3.71 vs. 5.72 episodes/patient-year, P < 0.05). Weight gain was 2.3 and 1.3 kg with IDegAsp and IDet, respectively (P < 0.05). Total insulin dose was 13% lower in the IDegAsp group (P < 0.0001). No treatment differences were detected in Health-Related Quality of Life, laboratory measurements, physical examination, vital signs, electrocardiograms, fundoscopy, or adverse events.
conclusionsIDegAsp in basal-bolus therapy with IAsp at additional mealtimes improves overall glycemic control and was non-inferior to IDet, with a reduced risk of nocturnal hypoglycemia and fewer injections in comparison with IDet + IAsp basal-bolus therapy.
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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.