Lower hypoglycemia rates with insulin degludec compared to insulin glargine: Data from a prospectively planned meta-analysis
Bibliographic record
Abstract
Introducution: Insulin degludec (IDeg) is a new basal insulin that forms soluble multihexamers after sc injection. Ideg has long and stable glucose-lowering effect. Methods: The objective of this pre-specified analysis was to compare the rate of hypoglycemia with IDeg vs. IGlar across trials. Hypoglycemia was defined as follows: self-reported confirmed hypoglycaemia = PG< 56 mg/dL or severe hypoglycemia (requiring assistance) nocturnal confirmed hypoglycaemia = 00:01 – 05:59 incl. Rates were analyzed with a negative binomial regression model on patient level data. In the analysis all open-labeled, randomized, treat-to-target phase 3a trials of 26 or 52 weeks were included in which once-daily IDeg (n = 2899) was compared to IGlar (n = 1431) in T1DM (2 trials) and T2DM (5 trials). Results: IDeg showed statistically significantly lower rates for nocturnal hypoglycemia compared to IGlar for the pooled population of type 1 and 2 diabetes and for overall hypoglycemia in T2DM (Table). More pronounced benefits of Ideg could be revealed in analyses of the maintenance period (stable glycemia and insulin dose [obtained from 16 weeks onward]). Additional heterogeneity analysis revealed significantly less risk of severe hypoglycemia with IDeg vs. IGlar in insulinnaïve T2DM (rate ratio 0.14 [0.03; 0.70] 95% CI). Conclusion: This meta-analysis showed significantly lower rates especially for nocturnal hypoglycemia than IGlar at similar levels of A1C for Ideg compared to Iglar. Therefore treatment with Ideg may provide clinical advantages for patients. Table 1: Metaanalysis of confirmed hypoglycemia Rate overall hypoglycemia (Ideg/Iglar) Rate nocturnal hypoglycemia (Ideg/Iglar) Complete study Maintenance period Complete study Maintenance period T2DM 0.83 [0.74; 0.94]* 0.75 [0.66; 0.87]* 0.68 [0.57; 0.82]* 0.62 [0.49; 0.78]* T2DM-insulinnaive 0.83 [0.70; 0.98]* 0.72 [0.58; 0.88]* 0.64 [0.48; 0.86]* 0.51 [0.36; 0.72]* T1DM 1.10 [0.96; 1.26] 1.02 [0.88; 1.19] 0.83 [0.69; 1.00]* 0.75 [0.60; 0.94]* T1DM +T2DM 0.91 [0.83; 0.99]* 0.84 [0.75; 0.93]* 0.74 [0.65; 0.85]* 0.68 [0.58; 0.80]*
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.017 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.032 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".