Gla-100 Development: a Story of 'Serendipitous' Disruptive Innovation.

Ever since the discovery of insulin a century ago, relentless attempts have been made to develop insulins that closely mimic the timeaction- profile of human physiologic insulin. The early basal insulins like neutral protamine Hagedorn (NPH), were intermediate-acting, with high risk of hypoglycemia. These primary limitations led to attempts at developing improved basal insulins with a longer duration of action. After several attempts at prolonging insulin action using phenol and structural modifications of the insulin hexamer, insulin glargine was developed in 1988. The superior and unique pharmacological properties, longer duration of action, and significantly lowered risk of hypoglycemia enabled insulin glargine to be distinguished from NPH as a better basal insulin, providing holistic glycemic control. The present review highlights the circumstances that led to the search of truly basal insulins, focusing on the journey of insulin glargine 100 U/mL (Gla-100).

Prevalence of diagnosed and undiagnosed diabetes and hypertension in India--results from the Screening India's Twin Epidemic (SITE) study.

OBJECTIVE: Despite the rising number of patients with diabetes and hypertension in India, there is a dearth of nationwide, comprehensive prevalence data on these diseases. Our study aimed at collecting data on the prevalence of diabetes and hypertension and the underlying risk factors in various outpatient facilities throughout India. METHODS: This cross-sectional study was planned to be conducted in 10 Indian states, one state at a time. It was targeted to enroll about 2,000 patients from 100 centers in each state. Each center enrolled the first 10 patients (≥18 years of age, not pregnant, signed consent) per day on two consecutive days. "Diabetes" and "hypertension" were defined by the 2008 American Diabetes Association and the Joint National Committee's 7(th) Report guidelines, respectively. Patient data (demographics, lifestyle factors, medical history, and laboratory diagnostic results) were collected and analyzed. RESULTS: During 2009-2010, in total, 15,662 eligible patients (54.8% males; mean age, 48.9±13.9 years) from eight states were enrolled. Diabetes was prevalent in 5,427 (34.7%) patients, and 7,212 (46.0%) patients had hypertension. Diabetes and hypertension were coexistent in 3,227 (20.6%) patients. Among those whose disease status was not known at enrollment, 7.2% (793 of 11,028) and 22.2% (2,408 of 10,858) patients were newly diagnosed with diabetes and hypertension, respectively; additionally, 18.4% (2,031 of 11,028) were classified as having prediabetes and 60.1% (6,521 of 10,858) as having prehypertension. A positive association (P<0.05) was observed between diabetes/hypertension and age, familial history of either, a medical history of cardiovascular disorders, alcohol consumption, and diet. CONCLUSIONS: Our study demonstrates that the substantial burden of diabetes and hypertension is on the rise in India. Patient awareness and timely diagnosis and intervention hold the key to limiting this twin epidemic.

Improved glycaemic control with no weight gain: a 26-week, open label, non-randomised, non-interventional observational study on type 2 diabetes subjects using insulin detemir.

The aim of this study was to evaluate the weight change from baseline while using insulin detemir in subjects with type 2 diabetes mellitus under normal clinical practice conditions. It was a multicentre, open label, non-randomised, non-interventional, observational, safety and efficacy study in subjects using insulin detemir for the treatment of type 2 diabetes mellitus. In this study, the mean body weight decreased marginally by -0.8 kg at the end of week 26 from baseline. Change in mean body weight during the study was not statistically significant (p > 0.05). There was a statistically significant (p < -0.05) change in waist circumference (-0.7 cm) from baseline at week 26. Mean fasting plasma glucose reduced significantly (p < 0.0001) from 199.1 mg/dl at initiation of insulin detemir to 141.3 mg/dl at week 13 and 115.8 mg/dl at week 26. Mean HbA1c reduced significantly (p < 0.0001) from 9.2% at initiation of insulin detemir to 7.8% at week 13 and 7.2% at week 26. Insulin dose changed marginally from the baseline (15.1 units) to week 26 (15.3 units). Majority of the subjects (89%) were on once daily insulin detemir. Before initiating insulin detemir proportion of subjects experiencing at least one episode of hypoglycaemia during the past four weeks was 8.8% (n = 884). It was reduced 2.4% (n = 241) at week 13 and 1.6% (n = 164) at week 26 following initiation of insulin detemir. There were no major nocturnal hypoglycaemic episodes during 26 weeks of insulin detemir therapy. In conclusion, this study indicates that insulin detemir is safe, effective and weight neutral.