Dataset Information

Patient characteristics associated with improvement in glycemic control following addition of an oral antidiabetic drug to DPP-4 inhibitor monotherapy in Japanese patients with type 2 diabetes mellitus (JDDM 60).

ABSTRACT:

Aims

The current study evaluated patient demographics and clinical characteristics that associated with HbA1c reduction following addition of one oral antidiabetic drug (OAD) to DPP4i monotherapy.

Methods

A retrospective study was conducted using CoDiC database. Adult T2DM patients treated with sitagliptin monotherapy for ≥ 6 months and adding one OAD were extracted. Association between patient characteristics at the time of add-on OAD and following HbA1c reduction was assessed.

Results

Of 444 included patients, mean age was 62 years and 33% were female. All add-on OAD classes demonstrated further HbA1c reduction (p < 0.05). The majority received biguanide (BG; 61%) or sulfonylurea (SU; 25%) add-on therapy. BG and SU groups showed a significant association between higher baseline HbA1c categories and greater HbA1c reductions (BG: - 0.24 to - 1.75%, p < 0.0001; SU: - 0.15 to - 2.11%, p < 0.0001). Lower HDL-cholesterol/higher non-HDL-cholesterol (BG), male gender (SU), and lower SBP (SU) were associated with larger HbA1c reductions. The results for baseline HbA1c (BG and SU) and gender (SU) were also confirmed by multivariate analysis.

Conclusion

The majority of Japanese T2DM patients on sitagliptin monotherapy who require an add-on OAD utilized BG or SU. There were 2 determinants of glycemic response: baseline HbA1c with BG and SU and gender with SU during add-on OAD therapy.

Supplementary information

The online version contains supplementary material available at 10.1007/s13340-021-00514-5.

SUBMITTER: Kawai K

PROVIDER: S-EPMC8733084 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionThe goal of treatment in diabetes is to control hyperglycemia to near-normal glucose levels, which is important to prevent the progression of microvascular and macrovascular complications. Mitiglinide is a rapid- and short-acting insulinotropic sulfonylurea receptor ligand that is known to improve postprandial hyperglycemia in patients with type 2 diabetes. The aim of this study was to investigate the long-term efficacy and safety of mitiglinide in Japanese type 2 diabetic patients inadequately controlled by dipeptidyl peptidase-4 (DPP-4) inhibitor or biguanide monotherapy.MethodsIn patients with type 2 diabetes mellitus (T2DM) receiving a stable monotherapy regimen with a DPP-4 inhibitor or biguanide added to dietary therapy, an additional 10 mg mitiglinide was administered for 52 weeks. The efficacy end points were postprandial plasma glucose (PPG) (30 min, 1 h, 2 h), postprandial insulin (30 min, 1 h, 2 h), insulinogenic index, 1,5-anhydroglucitol (1,5-AG), glycated hemoglobin (HbA1c), and fasting plasma glucose. The safety end points included the incidence and types of adverse events and adverse drug reactions.ResultsA total of 136 patients with T2DM were eligible for enrollment in this study and received mitiglinide. The average HbA1c before the start of mitiglinide administration (baseline) was 7.47% in the DPP-4 inhibitor combined treatment group (DPP-4 inhibitor CTG) and 7.50% in the biguanide combined treatment group (biguanide CTG), and the 2 h PPG was 248.1 and 243.3 mg/dL, respectively. Following the addition of mitiglinide to the treatment regimen for 52 weeks, the early postprandial decrease in insulin secretion improved and PPG improved in both the DPP-4 inhibitor CTG and biguanide CTG. At final evaluation, the HbA1c <7.0% achievement rate was 57.4% in the DPP-4 inhibitor CTG and 29.2% in the biguanide CTG. The incidence of hypoglycemia in the DPP-4 inhibitor CTG and biguanide CTG was 3.0% (2/67 patients) and 2.9% (2/69 patients), respectively. The hypoglycemic symptoms were mild in all cases.ConclusionCombination therapy with mitiglinide and DPP-4 inhibitors or biguanides improved glycemic control over the long term without increasing risks to safety due to events such as hypoglycemia, and this is a clinically promising therapeutic strategy in T2DM.

Project description:Aims/introductionTo investigate the effect of patient characteristics on imeglimin effectiveness in Japanese patients with type 2 diabetes mellitus.Materials and methodsData were pooled from two randomized, placebo-controlled, 24-week, double-blind studies of imeglimin monotherapy in Japanese adults with type 2 diabetes mellitus, with the proportion of responders (glycated hemoglobin [HbA1c] < 7.0%) and sustained responders (i.e., achieved and maintained response) in the imeglimin 1,000 mg twice daily group calculated at each visit. Patient factors significantly (P < 0.05) correlated with response were explored through multivariate logistic regression. Subgroup analyses compared the efficacy of imeglimin in patients with a HbA1c improvement less than or equal to -0.3% (early responders) versus greater than -0.3% (early non-responders) at week 4.ResultsA total of 38.0% of imeglimin-treated patients and 7.2% of placebo-treated patients were responders (P < 0.001, number needed to treat = 4). The proportion of sustained responders at weeks 4, 8, 12, 16 and 20 was 10.6, 19.0, 24.0, 25.7 and 29.1%, respectively (>70% of responders at each visit). Improvements in HbA1c and fasting glucose were significantly greater in early responders versus early non-responders from week 4; between-group differences remained significant to week 24. Older age (odds ratio 1.09, 95% confidence interval 1.04-1.14; P < 0.001); treatment-naïve status vs previous treatment (odds ratio 3.70, 95% confidence interval 1.55-8.82; P = 0.003), and lower baseline HbA1c (odds ratio 0.06, 95% confidence interval 0.02-0.16; P < 0.001) predicted response.ConclusionsA significantly higher proportion of patients receiving imeglimin 1,000 mg twice daily monotherapy were responders versus placebo. Most (>70%) were sustained responders, suggesting that response is fairly predictable. Older age, treatment-naïve status and early treatment response significantly predicted imeglimin effectiveness.