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Clinical characteristics and patient treatment satisfaction with Humalog U-200 in patients with type 2 diabetes mellitus: an observational study.

ABSTRACT: Background: There are limited data on the real-world evidence of Humalog 200 units/ml KwikPen (U-200) insulin. We assessed the use of U-200 insulin in UK routine clinical practice to provide information on clinical characteristics, treatment satisfaction and short-term clinical outcomes. Methods: Nine patients with type 2 diabetes who initiated U-200 in secondary care and a further 12 identified from primary care electronic database were enrolled. A treatment satisfaction questionnaire was administered to the 19 secondary care patients. Follow-up data on clinical parameters were collected at 3 and 6 months following initial U-200 insulin administration and the data were used to assess changes in clinical outcomes from baseline. Results: Secondary care patients had a mean age 60 ± 11 years, mean HbA1c of 8.6% ± 1.3% and a mean BMI of 39.7 ± 5.3 kg/m2 at baseline. Primary care database patients had a mean age 57 ± 13 years, mean HbA1c 10.3% ± 1.7 and a mean BMI 42.3 ± 3.8 kg/m2. The nine participants' responses to the questionnaire suggested a high preference for U-200 over a previous mealtime insulin pen (PMIP). On average, the patients agreed that U-200 was quicker to inject, had a better controlled home blood glucose reading and less discomfort at the injection site compared to a PMIP. Patients were willing to continue with their U-200 treatment. No significant HbA1c reduction was observed at 3 months in the secondary care group (-0.5%), but marked significant reduction in HbA1c was seen at 3 months in the primary care dataset to (-2.8%; p < .0004). There was also some suggestion of weight loss in both the secondary and primary care groups. Conclusion: Humalog U-200 insulin users were comprised mainly of older patients with diabetes complications and high HbA1c levels at the time of U-200 initiation. Overall, U-200 improved patients' satisfaction with diabetes treatment and short-term metabolic outcomes.

SUBMITTER: Mamza J

PROVIDER: S-EPMC6968701 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background:The benefits of sodium glucose cotransporters 2 (SGLT2) inhibitors in patients with type 2 diabetes mellitus include plasma glucose control, reduction in body weight and blood pressure, and low risk of hypoglycemia, although they may also cause genitourinary infections, polyuria, or volume depletion. It is not clear whether dapagliflozin, an SGLT2 inhibitor, improves treatment satisfaction among patients in a comprehensive way despite the negative side effects. This study assessed the effect of dapagliflozin on glycosylated hemoglobin (HbA1c), body weight, and treatment satisfaction in overweight patients with type 2 diabetes mellitus treated with oral hypoglycemic agents. Methods:This multicenter, open-label, single-arm observational study included patients with type 2 diabetes mellitus administering dapagliflozin 5 or 10 mg per day for 14 weeks. Changes in treatment satisfaction were evaluated using a new version of the Oral Hypoglycemic Agent-Questionnaire (OHA-Q ver. 2) consisting of 23 items. Correlation between treatment satisfaction and HbA1c levels and body weight were analyzed using the Spearman's rank-correlation coefficient. Results:Of the 221 patients enrolled, 188 completed the study. Mean HbA1c decreased from 7.8 ± 0.7% (62.1 ± 7.5 mmol/mol) to 7.3 ± 0.8% (55.9 ± 8.7 mmol/mol) (change - 0.6 ± 0.7%, P < 0.001) and body weight decreased from 82.5 ± 14.6 to 80.7 ± 14.8 kg (change - 2.3 ± 2.8 kg, P < 0.001). OHA-Q ver. 2 was validated as well, the mean OHA-Q ver. 2 total score increased from 44.3 ± 9.4 to 46.6 ± 9.8 (best score 69, worst score 0; change 2.3 ± 6.6, P < 0.001). The change in body weight significantly correlated with the OHA-Q ver. 2 total score (Spearman's ? = - 0.17, P = 0.035). The change in HbA1c levels significantly correlated with the satisfaction subscale score (Spearman's ? = - 0.19, P = 0.011). Conclusions:Dapagliflozin significantly improved treatment satisfaction among patients with type 2 diabetes mellitus for 14 weeks. Body weight loss significantly correlated with treatment satisfaction.Trial registration UMIN-CTR: UMIN000016304.

Project description:IntroductionIn Japan, patient-led insulin titration is rare in type 2 diabetes mellitus (T2DM) patients. Few studies have compared the effects of patient-led versus physician-led insulin titration on patient-reported outcomes in Japanese T2DM patients. This study aimed to compare the effects of patient-led and physician-led insulin titration in Japanese insulin-naïve T2DM patients on safety, glycemic control, and patient-reported outcomes (emotional distress, treatment satisfaction, and self-efficacy).MethodsUltimately, 125 insulin-naïve Japanese T2DM patients were randomly assigned to either a patient-led insulin self-titration group or a physician-led insulin titration group and monitored for 24 weeks. The primary endpoint was a change in emotional distress as measured using the Problem Areas in Diabetes scale (PAID). Secondary endpoints included treatment satisfaction, as measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ), self-efficacy as measured using the Insulin Therapy Self-Efficacy Scale (ITSS), glycated hemoglobin (HbA1c) levels, fasting plasma glucose levels, body weight, insulin daily dose, and frequency of hypoglycemia.ResultsThere was no significant difference between the groups in PAID and DTSQ scores. The results for the primary endpoint should be interpreted taking account that the sample size for the power calculation was not reached. ITSS scores were significantly higher in the patient-led self-titration group. HbA1c and fasting plasma glucose levels were significantly decreased in both groups, but the decrease was significantly larger in the patient-led self-titration group. Although the insulin daily dose was significantly higher in the patient-led self-titration group, severe hypoglycemia did not occur in either group, and the frequency of hypoglycemia was similar in both groups.ConclusionSelf-measurement of blood glucose and self-titration of insulin enhanced the patients' self-efficacy without compromising their emotional distress or treatment satisfaction. Also, insulin self-titration was found to be safe and effective; it resulted in better glycemic control without severe hypoglycemia.Trial registrationUniversity Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (registration number: UMIN000020316).

Project description:BACKGROUND: Sub-Saharan Africa faces a rapid spread of diabetes mellitus type 2 (DM2) but its potentially specific characteristics are inadequately defined. In this hospital-based study in Kumasi, Ghana, we aimed at characterizing clinical, anthropometric, socio-economic, nutritional and behavioural parameters of DM2 patients and at identifying associated factors. METHODS: Between August 2007 and June 2008, 1466 individuals were recruited from diabetes and hypertension clinics, outpatients, community, and hospital staff. Fasting plasma glucose (FPG), serum lipids and urinary albumin were measured. Physical examination, anthropometry, and interviews on medical history, socio-economic status (SES), physical activity and nutritional behaviour were performed. RESULTS: The majority of the 675 DM2 patients (mean FPG, 8.31 mmol/L) was female (75%) and aged 40-60 years (mean, 55 years). DM2 was known in 97% of patients, almost all were on medication. Many had hypertension (63%) and microalbuminuria (43%); diabetic complications occurred in 20%. Overweight (body mass index > 25 kg/m2), increased body fat (> 20% (male), > 33% (female)), and central adiposity (waist-to-hip ratio > 0.90 (male), > 0.85 (female)) were frequent occurring in 53%, 56%, and 75%, respectively. Triglycerides were increased (? 1.695 mmol/L) in 31% and cholesterol (? 5.17 mmol/L) in 65%. Illiteracy (46%) was high and SES indicators generally low. Factors independently associated with DM2 included a diabetes family history (adjusted odds ratio (aOR), 3.8; 95% confidence interval (95%CI), 2.6-5.5), abdominal adiposity (aOR, 2.6; 95%CI, 1.8-3.9), increased triglycerides (aOR, 1.8; 95%CI, 1.1-3.0), and also several indicators of low SES. CONCLUSIONS: In this study from urban Ghana, DM2 affects predominantly obese patients of rather low socio-economic status and frequently is accompanied by hypertension and hyperlipidaemia. Prevention and management need to account for a specific risk profile in this population.

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Clinical characteristics and patient treatment satisfaction with Humalog U-200 in patients with type 2 diabetes mellitus: an observational study.

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