In this study, Ipragliflozin (IP) 50 mg was administered once a day for 52 weeks to Japanese patients with type 2 diabetes mellitus. Of the 458 enrolled patients, 451 were included in the safety analysis, and 376 were included in the efficacy analysis. Glycated hemoglobin, serum lipids, liver enzymes, blood pressure, and body composition were estimated and analyzed by multiple comparisons. The changes at week 52 were −0.9 % for glycated hemoglobin, −2.8 kg for body weight, −1.8 kg for body fat mass, and −1.0 kg for lean mass (p<0.001). Furthermore, significant improvements were observed in the liver enzyme levels, serum lipid levels (high-density lipoprotein-cholesterol and triglyceride), and blood pressure, whereas no significant change was exhibited in the pulse rate. Adverse events were noted in 120/451 patients (26.6 %), the most common being vulvovaginal candidiasis. Treatment with IP demonstrated improvements in the glycemic control and liver function and also reduced the body weight and body fat. IP appeared to exert a minimal impact on the hemodynamics, as evidenced by no significant change in the pulse rate despite a decrease in the blood pressure. Thus, IP can be considered an efficacious and safe drug.
In some patients, diabetes treatment with subcutaneous injection can cause subcutaneous adipose tissue changes with or without palpable subcutaneous indurations. Those changes can subsequently lead to unstable glycemic control. We followed 44 patients who had their subcutaneous region injection sites examined for changes in the sonographic appearance and their glycemic control evaluated after the patients switched their injection sites. We divided the subcutaneous regions into three groups according to the sonographic appearance: hyperechoic regions as group H, mixed regions as group M and hypoechoic regions as group L. In group H, 40.7 % of regions were non-palpable. The average HbA1c levels were decreased at 2 and 12 months after the patients began avoiding injecting into their subcutaneous regions. We later re-examined the ultrasonography findings of 23 patients from group H, 9 from group M and 3 from group L. In 15 patients from group H and 5 from group M, the hyperechoic regions had vanished or improved 2-48 months after the patients began avoiding subcutaneous injection. However, we did not detect any marked improvement in group L. These findings suggest that the examination of subcutaneous regions by ultrasonography is useful for ensuring stable glycemic control even when palpable indurations cannot be detected.
A 65-year-old man had been diagnosed with type 1 diabetes at 27 years of age and had been on intensive insulin therapy ever since. Throughout his course, he had achieved good blood glucose control through strict lifestyle management and self-regulation of insulin. In August X, he slipped into a hypoglycemic coma and was transported to our emergency room, as he had fallen asleep just after an injection of short-acting insulin without eating anything. His consciousness improved promptly by the administration of glucose. The existence of frequent hypoglycemia was suspected from his medical history and his HbA1c value of 5.9 % at hospitalization. His Mini Mental State Examination score was 25 points, and mild cognitive decline was observed. Importantly, no microvascular complications were observed. Despite a 40-year history of type 1 diabetes, this patient successfully prevented diabetic microvascular complications. However, he developed mild cognitive decline. We report this case as an example suggesting the paradoxical utility and adverse effects of strict blood glucose reduction in elderly diabetic patients.
A 74-year-old woman who had not visited a hospital, received a medical checkup, or been diagnosed with diabetes previously felt malaise, loss of appetite, and a sense of thirst in early May X. Because these symptoms did not improve, she visited a hospital in mid-May. She had a fever exceeding 38 °C. Her random plasma glucose level was 396 mg/dL, HbA1c 11.1 %, CRP 9.0 mg/dL, and WBC 13000 /μL (neutrophils 88 %). Based on these findings, diabetes with infection was suspected, and the patient was referred to our hospital. On admission, her blood amylase was elevated at 483 IU/L, and enhanced computed tomography (CT) was performed for a further examination. CT findings suggested an infected aortic aneurysm at the bifurcation of the renal artery. The infection was controlled by a multidisciplinary approach, including antibiotic therapy, but the aneurysm became larger. The patient was transferred to Tokyo Women's Medical University Hospital and received surgical treatment. In this patient, the causative bacteria were not identified, as all bacterial cultures of specimens obtained before and after the administration of antibiotics and during surgery were negative, which made it difficult to de-escalate antibiotics and prolonged the duration of treatment.
The patient was a 67-year-old woman who had started treatment when diagnosed with type 2 diabetes at 39 years of age but had poor glycemic control due to poor insight into her illness. During the disease course, the left toe and right lower extremity were amputated for the treatment of diabetic gangrene. The patient was referred and admitted to our hospital due to a fever, nausea, abdominal pain, and low-back pain suggesting infectious gastroenteritis. She responded poorly to antimicrobial therapy. She was old and thus had no pathognomonic physical findings. Blood cultures and a second computed tomography scan led to a diagnosis of bilateral iliopsoas muscle abscesses caused by the low-virulent indigenous bacterium, Streptococcus agalactiae (GBS). GBS is a rare pathogenic agent of bilateral iliopsoas muscle abscesses. However, diabetic patients with poor glycemic control who have undergone a lower extremity amputation carry a risk of developing GBS infection, which may lead to bilateral iliopsoas muscle abscesses. In old diabetic patients, pathognomonic physical findings are lacking. Thus, when they present with a fever and low-back pain, bilateral iliopsoas muscle abscesses should be considered in the differential diagnosis, for which repeated careful examinations and an early diagnosis are important.