Initial treatment with fixed‐dose combination rosiglitazone/glimepiride in patients with previously untreated type 2 diabetes
Bibliographic record
Abstract
AIM: This study assessed the efficacy and safety of two different dosing regimens of fixed-dose combination (FDC) rosiglitazone (RSG) plus glimepiride (GLIM) compared with RSG or GLIM monotherapy in drug-naive subjects with type 2 diabetes mellitus (T2DM). METHODS: Drug-naive subjects (n = 901) were enrolled into this 28-week, double-blind, parallel-group study if their glycosylated haemoglobin A(1c) (HbA(1c)) was >7.5% but <or=12%. Subjects were randomized to receive either GLIM [4 mg once daily (OD) maximal], RSG (8 mg OD maximal) or RSG/GLIM FDC regimen A (4 mg/4 mg OD maximal) or RSG/GLIM FDC regimen B (8 mg/4 mg OD maximal). Patients were assessed for efficacy and safety every 4 weeks for the first 12 weeks of the study, and at weeks 20 and 28. The primary efficacy endpoint was change in HbA(1c) from baseline. Key secondary endpoints included the proportion of patients achieving recommended HbA(1c) and fasting plasma glucose (FPG) targets; change from baseline in FPG, insulin, C-reactive protein (CRP), adiponectin, free fatty acids and lipids; and percentage change in homeostasis model assessment-estimated insulin sensitivity and beta-cell function. Safety evaluations included adverse-event (AE) monitoring and clinical laboratory evaluations. RESULTS: At week 28, both RSG/GLIM FDC regimens significantly reduced HbA(1c) (mean +/- s.d.: -2.4 +/- 1.4% FDC regimen A; -2.5 +/- 1.4% FDC regimen B) to a greater extent than RSG (-1.8 +/- 1.5%) or GLIM (-1.7 +/- 1.4%) monotherapy (model-adjusted mean treatment difference, p < 0.0001 vs. both RSG and GLIM). Significantly more subjects achieved HbA(1c) target levels of <or=6.5 and <7% with either RSG/GLIM FDC regimen compared with RSG or GLIM alone (model-adjusted odds ratio, p < 0.0001 for both comparisons). Similarly, a significantly greater reduction in FPG levels was observed in subjects treated with the RSG/GLIM FDC [mean +/- s.d. (mg/dl): -69.5 +/- 57.5 FDC regimen A; -79.9 +/- 56.8 FDC regimen B) compared with RSG (-56.6 +/- 58.1) or GLIM (-42.2 +/- 66.1) monotherapy (model-adjusted mean treatment difference, p < 0.0001 for both comparisons). Improvement in CRP was also observed in subjects who were treated with a RSG/GLIM FDC or RSG monotherapy compared with GLIM monotherapy. RSG/GLIM FDC was generally well tolerated, with no new safety or tolerability issues identified from its monotherapy components, and a similar AE profile was observed across FDC regimens. The most commonly reported AE was hypoglycaemia, and the incidence of confirmed symptomatic hypoglycaemia (3.6-5.5%) was comparable among subjects treated with an RSG/GLIM FDC and GLIM monotherapy. CONCLUSIONS: Compared with RSG or GLIM monotherapy, the RSG/GLIM FDC improved glycaemic control with no significant increased risk of hypoglycaemia. RSG/GLIM FDC provides an effective and well-tolerated treatment option for drug-naive individuals with T2DM.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".