Trial reportDiabetes, obesity & metabolism2016
Randomized, double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 1 diabetes: IMAGINE 3.
Trial report in Diabetes, obesity & metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis 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
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.
- Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials.Therapeutic innovation & regulatory science · 2023Pooled it
- Reduced hypoglycaemia using liver-targeted insulin in individuals with type 1 diabetes.Diabetes, obesity & metabolism · 2022Trial
- The PNPLA3 I148M variant is associated with transaminase elevations in type 2 diabetes patients treated with basal insulin peglispro.The pharmacogenomics journal · 2018Trial
- Dose Unit Establishment for a New Basal Insulin Using Joint Modeling of Insulin Dose and Glycemic Response.Journal of diabetes science and technology · 2018Trial
- Hypoglycemia Risk Related to Double Dose Is Markedly Reduced with Basal Insulin Peglispro Versus Insulin Glargine in Patients with Type 2 Diabetes Mellitus in a Randomized Trial: IMAGINE 8.Diabetes technology & therapeutics · 2017Trial
- Randomized double-blind clinical trial comparing basal insulin peglispro and insulin glargine, in combination with prandial insulin lispro, in patients with type 2 diabetes: IMAGINE 4.Diabetes, obesity & metabolism · 2016Trial
- Reduced nocturnal hypoglycaemia with basal insulin peglispro compared with insulin glargine: pooled analyses of five randomized controlled trials.Diabetes, obesity & metabolism · 2016Trial
- The Silver Jubilee (2025) of Insulin Glargine: Introducing the Era of Long-Acting Insulin Analogues for Diabetes Mellitus.Diabetes, obesity & metabolism · 2026Review
- 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
- Comment on "Adverse Impacts of PEGylated Protein Therapeutics: A Targeted Literature Review".BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- Adverse Impacts of PEGylated Protein Therapeutics: A Targeted Literature Review.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2024Review
- The Basis for Weekly Insulin Therapy: Evolving Evidence With Insulin Icodec and Insulin Efsitora Alfa.Endocrine reviews · 2024Review
- Insulin Therapy for the Management of Diabetes Mellitus: A Narrative Review of Innovative Treatment Strategies.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Review
- One hundred years of insulin therapy.Nature reviews. Endocrinology · 2021Review
- Why ITT analysis is not always the answer for estimating treatment effects in clinical trials.Contemporary clinical trials · 2021Article
- The Peripheral Peril: Injected Insulin Induces Insulin Insensitivity in Type 1 Diabetes.Diabetes · 2020Review
- Peripherally delivered hepatopreferential insulin analog insulin-406 mimics the hypoglycaemia-sparing effect of portal vein human insulin infusion in dogs.Diabetes, obesity & metabolism · 2019Article
- [Insulin therapy-new insulin analogues].Der Internist · 2019Review
- Time-Averaged Self-Monitored Blood Glucose Values Estimate Hemoglobin A1c Outcomes in Patients With Type 1 Diabetes.Journal of diabetes science and technology · 2018Article
- Relationship of Glucose Variability With Glycated Hemoglobin and Daily Mean Glucose: A Post Hoc Analysis of Data From 5 Phase 3 Studies.Journal of diabetes science and technology · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 5 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo compare the efficacy and safety of basal insulin peglispro (BIL), which has a flat pharmacokinetic and pharmacodynamic profile and a long duration of action, with insulin glargine (GL) in patients with type 1 diabetes. MATERIALS AND
methodsIn this phase III, 52-week, blinded study, we randomized 1114 adults with type 1 diabetes in a 3 : 2 distribution to receive either BIL (n = 664) or GL (n = 450) at bedtime, with preprandial insulin lispro, using intensive insulin management. The primary objective was to compare glycated haemoglobin (HbA1c) in the groups at 52 weeks, with a non-inferiority margin of 0.4%.
resultsAt 52 weeks, mean (standard error) HbA1c was 7.38 (0.03)% with BIL and 7.61 (0.04)% with GL {difference -0.22% [95% confidence interval (CI) -0.32, -0.12]; p < 0.001}. At 52 weeks more BIL-treated patients reached HbA1c <7% (35% vs 26%; p < 0.001), the nocturnal hypoglycaemia rate was 47% lower (p < 0.001) and the total hypoglycaemia rate was 11% higher (p = 0.002) than in GL-treated patients, and there was no difference in severe hypoglycaemia rate. Patients receiving BIL lost weight, while those receiving GL gained weight [difference -1.8 kg (95% CI -2.3, -1.3); p < 0.001]. Treatment with BIL compared with GL at 52 weeks was associated with greater increases from baseline in levels of serum triglyceride [difference 0.19 mmol/l (95% CI 0.11, 0.26); p < 0.001] and alanine aminotransferase (ALT) levels [difference 6.5 IU/l (95% CI 4.1, 8.9), p < 0.001], and more frequent injection site reactions.
conclusionsIn patients with type 1 diabetes, treatment with BIL compared with GL for 52 weeks resulted in a lower HbA1c, more patients with HbA1c levels <7%, and reduced nocturnal hypoglycaemia, but more total hypoglycaemia and injection site reactions and higher triglyceride and ALT levels.
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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.