Efficacy and Safety of Ipragliflozin in Patients With Type 2 Diabetes: ASSIGN-K Study
Bibliographic record
Abstract
Background: Sodium glucose cotransporter 2 (SGLT2) inhibitors achieve good glycemic control in patients with type 2 diabetes, as well as reducing body weight and blood pressure. However, no large-scale clinical studies of SGLT2 inhibitors have been performed in Japan. The ASSIGN-K study investigated the efficacy and safety of ipragliflozin, a selective SGLT2 inhibitor, in routine clinical practice. Methods: ASSIGN-K was an investigator-initiated, multicenter, prospective observational study of ipragliflozin that enrolled Japanese patients with type 2 diabetes who showed inadequate glycemic control despite diet and exercise with/without medication. Patients received ipragliflozin (50 mg/day) as monotherapy or combined with other antidiabetic agents for up to 104 weeks. Results: In 301 patients who completed104 weeks of ipragliflozin treatment, hemoglobin A1c was significantly reduced from 8.07% at baseline to 7.24% (P < 0.001), while fasting blood glucose (n = 86) and postprandial blood glucose (n = 75) were decreased significantly by 19.8 mg/dL (P < 0.001) and 29.6 mg/dL (P < 0.05), respectively. Body weight (n = 217) also showed a significant decrease from 79.1 kg to 76.2 kg (P < 0.001). In addition, body fat (n = 217) and fat-free mass (n = 217) were significantly reduced by 1.87 kg and 1.02 kg, respectively (both P < 0.001), while total body water displayed a significant decrease of 0.74 kg (P < 0.001). Similar results were obtained when 30 patients aged ? 65 years were compared with 187 patients aged < 65 years. Multiple regression analysis revealed greater improvement of hemoglobin A1c when the baseline value was higher, while improvement became less marked as the duration of diabetes became longer and as the baseline body mass index increased. In patients achieving hemoglobin A1c < 7.0%, baseline hemoglobin A1c was significantly lower than in patients not achieving hemoglobin A1c < 7.0%, (7.45% vs. 8.54%, P < 0.001) and the duration of diabetes was significantly shorter (8.66 vs. 10.69 years, P = 0.002). Ketoacidosis was only reported in patients who continued ipragliflozin treatment during intercurrent illness. Conclusions: In patients with type 2 diabetes and inadequate glycemic control, ipragliflozin significantly improved hemoglobin A1c regardless of baseline characteristics, including age, sex, hemoglobin A1c, and body mass index. However, it is important to suspend treatment with ipragliflozin during intercurrent illness. J Endocrinol Metab. 2019;9(3):51-62 doi: https://doi.org/10.14740/jem570
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".