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INTRODUCTION: MOSAIc was a multinational, non-interventional, prospective, observational cohort study designed to provide an understanding of the specific challenges associated with intensification of initial insulin therapy in patients with type 2 diabetes mellitus (T2DM). We present a sub-analysis of Japanese patients from MOSAIc, with data analyzed longitudinally over 2 years, to provide insight on how T2DM treatment is intensified. METHODS: Japanese patients with T2DM receiving any insulin therapy for at least 3 months were eligible for study inclusion. Baseline and clinical data were collected during an initial baseline visit and during four subsequent prospective visit windows (within ± 3 months) at 6, 12, 18, and 24 months. Treatment intensification was defined as addition of new insulin, increase in insulin dosage (1-unit change or 10% compared with the previous visit), increase in insulin injection frequency, and/or addition of non-insulin antihyperglycemic agents. RESULTS: Of 116 Japanese patients who completed the study, 50.0% (n = 58) received treatment intensification. Baseline characteristics of patients with treatment intensification included a longer duration of diabetes, higher incidence of baseline microvascular complications, and higher HbA1c compared to those without intensification. There was no significant difference in HbA1c change from baseline between the two groups at any post-baseline visit. Insulin intensification accounted for 61.2% of treatment changes, with non-insulin-related intensification accounting for 36.2% of treatment changes. An increase in insulin dose was the most frequent treatment change (51.7%), followed by the addition of new insulin (22.4%), and an increase in insulin injection frequency (6.9%). CONCLUSION: Real-world data from Japanese patients with T2DM who received treatment intensification showed that an increase in insulin dose and the addition of new insulin were the most frequent treatment intensification methods. HbA1c was maintained through 2 years of treatment. TRIAL REGISTRATION: NCT01400971, ClinicalTrials.gov.
ABSTRACT
INTRODUCTION: Guidelines recommend insulin progression for patients with type 2 diabetes (T2D) with inadequate glycemic control. The Multinational Observational Study Assessing Insulin use (MOSAIc [ClinicalTrials.gov identifier, NCT01400971]) study is a 2-year observational study, investigating factors that influence insulin progression in T2D patients. In this first of two reports, we describe baseline clinical and psychosocial characteristics of Chinese, Japanese, and South Korean patients who participated in MOSAIc. Insulin treatment, factors affecting progression, and outcomes will be reported separately. METHODS: Patients with T2D using insulin for ≥3 months were eligible. Baseline demographic, clinical, and psychosocial data were collected from patients. Quality of life instruments, including the Diabetes Distress Scale (DDS), were used to assess patient's concerns about disease management, support, and emotional burden. The association between the DDS and the selected covariates was also assessed. RESULTS: A total of 373 patients in China, 157 in Japan, and 141 in South Korea were enrolled from July 2011 to July 2013. Mean ± standard deviation duration (years) of T2D differed across countries (China 11.4 ± 7.5; Japan 13.8 ± 8.7; South Korea 15.7 ± 8.8; P < 0.0001). Japanese patients used more noninsulin anti-hyperglycemic agents than did Chinese or South Korean patients (P < 0.0001). Exclusive use of basal insulin was most common in Japan and South Korea compared with China, whereas approximately 66.8% of Chinese patients used mixed insulin. Covariates associated with the DDS were younger age [P = 0.044 (Japan)], higher incidence of monthly hypoglycemia [P = 0.036 [China]; P = 0.021 (South Korea)], and male gender [P = 0.037 (South Korea)]. CONCLUSIONS: There were significant differences amongst East Asian patients with T2D treated with insulin, including in quality of life scores. Results from the MOSAIc longitudinal analyses will further investigate trends of insulin intensification and barriers to insulin progression. FUNDING: Eli Lilly and Company.
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BACKGROUND/AIMS: We investigated basal levels of serum and urinary lipocalin-type prostaglandin D synthase/beta-trace (L-PGDS) in type-2 diabetic patients and explored whether glycemic control affects L-PGDS status in another 55 diabetic inpatients with normoalbuminuria. METHODS: Fifty-five type-2 diabetic outpatients (HbA1c, 9.14 +/- 0.20%; creatinine (Cr), 85.1 +/- 2.4 micromol/l), and 55 age-matched healthy control subjects were recruited. Serum and urinary levels of L-PGDS were determined with respect to the stage of diabetic nephropathy. The L-PGDS was localized by immunohistochemistry. RESULTS: The urinary L-PGDS index increased in diabetic patients, compared with the controls (234.8 +/- 27.4 vs. 73.8 +/- 7.8 microg/mmol Cr, p < 0.001). Even in normoalbuminuric patients as well as in microalbuminuric patients, urinary L-PGDS indexes were higher than the controls (166.0 +/- 21.1, p < 0.0001 and 338.6 +/- 62.5 microg/mmol Cr, p < 0.0001, respectively), although the serum L-PGDS level was equal to that in the control subjects. Multiple regression analysis revealed that the urinary L-PGDS index was predicted solely by glucose levels and type-IV collagen index, whereas the serum L-PGDS was determined mainly by age and serum Cr. Glycemic control reduced the urinary L-PGDS index towards the normal range in diabetic patients with normoalbuminuria (172.3 +/- 6.6 vs. 118.1 +/- 2.6 (SE) microg/mmol Cr, p < 0.0001). Immunohistochemistry showed that L-PGDS was uniquely present in the renal tubules in diabetes while in nondiabetics, L-PGDS occurred solely in the peritubular interstitium, not in the tubular cells. CONCLUSION: Inadequate glycemic control is responsible for urinary L-PGDS excretion in the diabetic patients. Urinary L-PGDS is useful to predict subclinical renal injury associated with type-2 diabetes.
