Safety and efficacy of insulin degludec/liraglutide (<scp>ID</scp>egLira) added to sulphonylurea alone or to sulphonylurea and metformin in insulin‐naïve people with Type 2 diabetes: the <scp>DUAL IV</scp> trial
Why this work is in the frame
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Bibliographic record
Abstract
Abstract Aim To investigate the safety and efficacy of insulin degludec/liraglutide ( ID egLira), a novel combination product, as add‐on therapy for people with Type 2 diabetes uncontrolled on sulphonylurea therapy. Methods In this 26‐week, double‐blind trial, adults with Type 2 diabetes [HbA 1c 53–75 mmol/mol (7.0–9.0%)] were randomized to ID egLira ( n = 289) or placebo ( n = 146) as add‐on to pre‐trial sulphonylurea ± metformin, titrating to a fasting glycaemic target of 4.0–6.0 mmol/l. Treatment initiation was at 10 dose steps, and maximum dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Results The mean HbA 1c decreased from 63 mmol/mol (7.9%) to 46 mmol/mol (6.4%) with ID egLira and to 57 mmol/mol (7.4%) with placebo [estimated treatment difference –11 mmol/mol (95% CI –13; –10) or –1.02% (95% CI –1.18; –0.87); P < 0.001]. The HbA 1c target of 53 mmol/mol (<7%) was achieved by 79.2% of participants in the ID egLira group vs 28.8% in the placebo group [estimated odds ratio 11.95 (95% CI 7.22; 19.77); P < 0.001]. Mean weight change was +0.5 kg with ID egLira vs –1.0 kg with placebo [estimated treatment difference 1.48 kg (95% CI 0.90; 2.06); P < 0.001]. Confirmed hypoglycaemia occurred in 41.7 and 17.1% of ID egLira‐ and placebo‐treated participants, respectively, with rates of 3.5 vs 1.4 events/patient‐years of exposure [estimated rate ratio 3.74 (95% CI 2.28; 6.13); P < 0.001]. ID egLira was generally well tolerated. The rates of serious adverse events were 20.3 and 8.0 per 100 patient‐years of exposure with ID egLira and placebo, respectively, without obvious patterns in the type of events. Conclusions ID egLira can be used in people uncontrolled with sulphonylurea ± metformin to improve efficacy with a safety profile in line with previous DUAL trials.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it