Randomized Study to Characterize Glycemic Control and Short-Term Pulmonary Function in Patients with Type 1 Diabetes Receiving Inhaled Human Insulin (Exubera)
Bibliographic record
Abstract
OBJECTIVE: Previous studies with inhaled human insulin [Exubera (EXU); insulin human (recombinant DNA origin) Inhalation Powder, Pfizer Inc., New York, NY; Nektar Therapeutics, San Carlos, CA) show comparable efficacy to sc insulin and small declines in pulmonary function in type 1 and 2 diabetes. This is a detailed characterization of short-term efficacy and pulmonary safety profile of EXU. RESEARCH DESIGN AND METHODS: In a 24-wk multicenter study, 226 nonsmoking patients with type 1 diabetes and normal lung function were randomized to intensive regimens of premeal EXU or sc insulin for 12 wk (comparative phase), followed by sc insulin for 12 wk (washout phase). Glycosylated hemoglobin, hypoglycemia, general adverse events, and pulmonary function were measured. Forced expiratory volume in 1 sec and carbon monoxide diffusion capacity were measured using standardized equipment and methodology. RESULTS: Comparable declines from baseline in glycosylated hemoglobin were observed in both groups (0.5%) and sustained throughout the study. There was a higher rate of hypoglycemia (risk ratio 1.23; 90% confidence interval 1.16, 1.30) but a lower rate of severe hypoglycemia (risk ratio 0.51; 90% confidence interval 0.30, 0.86) with EXU vs. sc insulin. The treatment group differences in changes from baseline in forced expiratory volume in 1 sec and carbon monoxide diffusion capacity were small, occurred within 2 wk of EXU initiation, and were reversible shortly after discontinuation. More patients reported mild cough with EXU vs. sc insulin (30.9% vs. 7.8%, respectively). CONCLUSIONS: Three months of EXU therapy is as effective and well tolerated as intensive sc insulin therapy. This study supports the role of EXU in type 1 diabetes.
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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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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".