Indian Journal of Endocrinology and Metabolism, 2012
Pregnancy is a period that places great physiological stress on both the mother and the fetus. Wh... more Pregnancy is a period that places great physiological stress on both the mother and the fetus. When pregnancy is compounded by endocrine disorders such as hypothyroidism, the potential for maternal and fetal adverse outcomes can be immense. While a lot of attention has been focused on the adverse fetal outcomes consequent to hypothyroidism, attention is also being gradually directed towards the adverse maternal outcomes of this disorder. Role of antibody positivity in influencing outcomes in a euthyroid woman, also needs further clarification. Prompt diagnosis and treatment of hypothyroidism in pregnancy is very essential. Subclinical hypothyroidism also needs to be detected and treated to prevent adverse outcomes, especially maternal. Since women with hypothyroidism during pregnancy, especially of the autoimmune variety might have a flare up of the disorder post-partum, or might continue to require thyroxine replacement post-partum, adequate follow-up is mandatory. While targeted case finding is generally practised, recent evidence seems to indicate that universal screening might be a better option. In conclusion, routine screening, early confirmation of diagnosis and prompt treatment. Allied with regular post-partum follow up, is required to ensure favourable maternal and fetal outcomes.
Indian Journal of Endocrinology and Metabolism, 2016
Health is a state of being which includes much more than the mere absence of disease. The respons... more Health is a state of being which includes much more than the mere absence of disease. The responsibilities of health care professionals, too, extend far beyond the management of the disease. Health care providers focus not only on patients and drugs, but also work toward ensuring health in the community at large, using non-pharmacological means wherever appropriate. The aim of these interventions is not just to cure, but to prevent as well. One strategy to ensure good health is to maintain optimal hygiene.
Background A clear understanding of the anthropometric and sociodemographic risk factors related ... more Background A clear understanding of the anthropometric and sociodemographic risk factors related to BMI and hypertension categories is essential for more effective disease prevention, particularly in India. There is a paucity of nationally representative data on the dynamics of these risk factors, which have not been assessed among healthy reproductive-age Indian women. Objective This cross-sectional polycystic ovary syndrome (PCOS) task force study aimed to assess the anthropometric and sociodemographic characteristics of healthy reproductive-age Indian women and explore the association of these characteristics with various noncommunicable diseases. Methods We conducted a nationwide cross-sectional survey from 2018 to 2022 as part of the Indian Council of Medical Research–PCOS National Task Force study, with the primary aim of estimating the national prevalence of PCOS and regional phenotypic variations among women with PCOS. A multistage random sampling technique was adopted, and 7107 healthy women (aged 18-40 years) from 6 representative geographical zones of India were included in the study. The anthropometric indices and sociodemographic characteristics of these women were analyzed. Statistical analysis was performed to assess the association between exposure and outcome variables. Results Of the 7107 study participants, 3585 (50.44%) were from rural areas and 3522 (49.56%) were from urban areas. The prevalence of obesity increased from 8.1% using World Health Organization criteria to 40% using the revised consensus guidelines for Asian Indian populations. Women from urban areas showed higher proportions of overweight (524/1908, 27.46%), obesity (775/1908, 40.62%), and prehypertension (1008/1908, 52.83%) categories. A rising trend of obesity was observed with an increase in age. Women aged 18 to 23 years were healthy (314/724, 43.4%) and overweight (140/724, 19.3%) compared with women aged 36 to 40 years with obesity (448/911, 49.2%) and overweight (216/911, 23.7%). The proportion of obesity was high among South Indian women, with 49.53% (531/1072) and 66.14% (709/1072), using both World Health Organization criteria and the revised Indian guidelines for BMI, respectively. BMI with waist circumference and waist-to-height ratio had a statistically significant linear relationship (r=0.417; P<.001 and r=0.422; P<.001, respectively). However, the magnitude, or strength, of the association was relatively weak (0.3<|r|<0.5). Statistical analysis showed that the strongest predictors of being overweight or obese were older age, level of education, wealth quintile, and area of residence. Conclusions Anthropometric and sociodemographic characteristics are useful predictors of overweight- and obesity-related syndromes, including prehypertension, among healthy Indian women. Increased attention to the health of Indian women from public health experts and policy makers is warranted. The findings of this study can be leveraged to offer valuable insights, informing health decision-making and targeted interventions that mitigate risk factors of overweight, obesity, and hypertension. International Registered Report Identifier (IRRID) RR2-10.2196/23437
Indian Journal of Endocrinology and Metabolism, 2019
Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 diabetes mellitu... more Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 diabetes mellitus (T2DM) patients but the data available in existing clinical trial programmes on DPP4 inhibitors include limited number of patients from India. Hence, this study attempted to understand usage, efficacy and safety of saxagliptin as first add-on after metformin in Indians with T2DM. Methodology: It was a multicenter, prospective, non-interventional and observational study planned to enrol T2DM patients who were inadequately controlled with metformin alone and had been recently (i.e., within past 15 days) prescribed saxagliptin as an add-on to metformin. Type 1 diabetes mellitus, use of glucose lowering drugs apart from metformin or saxagliptin, pregnancy, lactation, and medical condition, which could interfere with safe completion of the study were excluded. Results: A total of 1109 participants (658 men and 451 women) with mean ± SD age of 51.17 ± 11.85 years were enrolled from 50 centres throughout India. Significant reduction was observed in mean ± SD change of HbA1c as − 0.86% ± 1.76 from baseline to after 3 months of therapy (P < 0.0001). The quality of life assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire was reported to be “good” or “neither good nor bad” by majority of the participants at baseline and after 3 months of treatment. A total of 15 adverse events (AEs) were reported in the study, however, no serious adverse event (SAE) occurred during the study. All AEs were of mild intensity and did not require any intervention. Conclusion: Overall, saxagliptin in combination with metformin was generally well-tolerated in Indian T2DM patients and new or unexpected safety events were not identified. This study is also registered on Clinicaltrials.gov (NCT02588859).
Diabetes can affect the nervous system in several ways. Of all the neurological complications of ... more Diabetes can affect the nervous system in several ways. Of all the neurological complications of diabetes, peripheral neuropathy is by far the commonest and has been extensively studied. The involvement of central nervous system can be in several forms. The underlying damage may be due to involvement of the large and small cerebral blood vessels as also due to metabolic derangement caused by prolonged hypoglycemia, anoxia or ketoacidosis. The neurological emergencies that occur in diabetes can be: 1) atherothrombotic and lacunar strokes; 2) convulsive disorder in the setting of both hypo and hyperglycemia; 3) coma; 4) cranial neuropathies; and 5) acute proximal muscle weakness. In patients with diabetes, atherothrombotic stroke is associated with poor outcome. Hyperglycemia at the time of stroke is an important risk factor for an adverse outcome than chronic stable diabetic state. Proper management of diabetes in these acute situations is crucial for a better outcome of the underlying disease process.
Background Type 2 diabetes mellitus (T2DM) worldwide continues to increase, in particular in Indi... more Background Type 2 diabetes mellitus (T2DM) worldwide continues to increase, in particular in India. Early T2DM diagnosis followed by appropriate management will result in more cardiovascular event free life years. However, knowledge of the cardiovascular profile of newly diagnosed T2DM patients is still limited. The aim of this study was to understand the extent of cardiovascular disease (CVD) risk of newly diagnosed T2DM patients in India. Methods A cross sectional observational study was conducted to evaluate clinical laboratory and socio-demographic parameters of 5,080 newly diagnosed T2DM patients (48.3 ± 12.8 years of age; 36.7% female). In addition, we determined their cardiovascular risk according to the guidelines of the Lipid Association of India (LAI) and the criteria of the QRISK3 score. Results Of the newly T2DM diagnosed patients in India 2,007(39.5%) were classified as "High risk" and 3,073 (60.5%) were classified as "Very high risk" based on LAI criteria. On average, patients had 1.7 ± 0.9 major atherosclerotic cardiovascular disease (ASCVD) risk factors. Low HDL-C value was the most frequent major risk (2,823; 55.6%) followed by high age (2,502; 49.3%), hypertension (2,141; 42.1%), smoking/tobacco use (1,078; 21.2%) and chronic kidney disease stage 3b or higher (568; 11.2%). In addition, 4,192 (82.5%) patients appeared to have at least one cholesterol abnormality and, if the latest LAI recommendations are applied, 96.5% (4,902) presented with lipid values above recommended targets.
Aims-To evaluate whether and what combinations of diabetes quality metrics were achieved in a mul... more Aims-To evaluate whether and what combinations of diabetes quality metrics were achieved in a multicentre trial in South Asia evaluating a multicomponent quality improvement intervention that Correspondence to: Megha K. Shah.
There is a need for ideal basal insulin which can overcome the unmet need of a truly once daily i... more There is a need for ideal basal insulin which can overcome the unmet need of a truly once daily insulin, with a flat peakless profile. Useful for all types of patients Insulin degludec is next generation insulin with a unique mode of protraction of forming soluble multi-hexamers and slow continuous absorption giving it a flat profile compared to the existing basal insulin. In patients with type 1 diabetes or with type 2 diabetes, at steady-state, the mean terminal half-life of insulin degludec was 25 hours, i.e., approximately twice as long as for insulin glargine (half-life of 12.1 hours). In once-daily dosing regimen it reaches steady state after approximately 3 days. The duration of action of insulin degludec was estimated to be beyond 42 hours in euglycaemic clamp studies and this gives the unique opportunity of flexible time dosing which is not an available option with the existing basal insulin. The glucose-lowering effect is evenly distributed across a 24-hour dosing interval with insulin degludec having 4 times lower variability than insulin glargine. This is an important attribute given the narrow therapeutic window of insulin and the goal of achieving night time and inter-prandial glycaemic control without increasing the risk for hypoglycaemia, a goal that is challenging given the variability of absorption and lower PK half-lives of current basal insulin products. The combination of the ultra-long, flat and stable profile with an improved hour-to-hour and day-to-day variability could present an improved risk-benefit trade-off with the lower risk of hypoglycaemia, allowing for targeting improved levels of glycaemic control.
Indian Journal of Endocrinology and Metabolism, 2011
Hypothyroidism is a disorder commonly encountered in pregnancy. While thyroid antibodies are pres... more Hypothyroidism is a disorder commonly encountered in pregnancy. While thyroid antibodies are present in up to 15% of women in the reproductive age group, overt hypothyroidism is noted in 0.3-0.5% of all pregnancies, and subclinical hypothyroidism in 2-3%. [1] The pregnant woman presents a unique challenge, as well as an unparalleled opportunity, for the thyroidologist.
Indian Journal of Endocrinology and Metabolism, 2016
drugs which offer broad spectrum glucometabolic control, including glucose, blood pressure, weigh... more drugs which offer broad spectrum glucometabolic control, including glucose, blood pressure, weight, and lipid control, helps facilitate this process. We therefore suggest that the Law of Therapeutic Parsimony be included as a cardinal guiding principle of therapeutics in diabetology.
To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin ... more To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add-on to sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy. Materials and methods: In this 26-week, phase IIIb, open-label, parallel-group, treat-to-target trial, conducted at 74 sites in 11 countries, insulin-naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53-97 mmol/mol (7.0-11.0%), body mass index 20-40 kg/m 2 and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once-daily IDegLira or IGlar U100, both as add-on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26. Results: A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%-points) with IDegLira and 18 mmol/mol (1.7%-points) with IGlar U100; confirming non-inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change-3.90 mmol/mol; 95% confidence interval [CI]-5.45;-2.35 (−0.36%-points; 95% CI-0.50,-0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference −1.92 kg; 95% CI-2.64,-1.19); severe or blood-glucose-confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference −15.37 U; 95% CI-19.60, −11.13). The overall treatment-emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates. Conclusions: The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population.
Indian Journal of Endocrinology and Metabolism, 2012
Pregnancy is a period that places great physiological stress on both the mother and the fetus. Wh... more Pregnancy is a period that places great physiological stress on both the mother and the fetus. When pregnancy is compounded by endocrine disorders such as hypothyroidism, the potential for maternal and fetal adverse outcomes can be immense. While a lot of attention has been focused on the adverse fetal outcomes consequent to hypothyroidism, attention is also being gradually directed towards the adverse maternal outcomes of this disorder. Role of antibody positivity in influencing outcomes in a euthyroid woman, also needs further clarification. Prompt diagnosis and treatment of hypothyroidism in pregnancy is very essential. Subclinical hypothyroidism also needs to be detected and treated to prevent adverse outcomes, especially maternal. Since women with hypothyroidism during pregnancy, especially of the autoimmune variety might have a flare up of the disorder post-partum, or might continue to require thyroxine replacement post-partum, adequate follow-up is mandatory. While targeted case finding is generally practised, recent evidence seems to indicate that universal screening might be a better option. In conclusion, routine screening, early confirmation of diagnosis and prompt treatment. Allied with regular post-partum follow up, is required to ensure favourable maternal and fetal outcomes.
Indian Journal of Endocrinology and Metabolism, 2016
Health is a state of being which includes much more than the mere absence of disease. The respons... more Health is a state of being which includes much more than the mere absence of disease. The responsibilities of health care professionals, too, extend far beyond the management of the disease. Health care providers focus not only on patients and drugs, but also work toward ensuring health in the community at large, using non-pharmacological means wherever appropriate. The aim of these interventions is not just to cure, but to prevent as well. One strategy to ensure good health is to maintain optimal hygiene.
Background A clear understanding of the anthropometric and sociodemographic risk factors related ... more Background A clear understanding of the anthropometric and sociodemographic risk factors related to BMI and hypertension categories is essential for more effective disease prevention, particularly in India. There is a paucity of nationally representative data on the dynamics of these risk factors, which have not been assessed among healthy reproductive-age Indian women. Objective This cross-sectional polycystic ovary syndrome (PCOS) task force study aimed to assess the anthropometric and sociodemographic characteristics of healthy reproductive-age Indian women and explore the association of these characteristics with various noncommunicable diseases. Methods We conducted a nationwide cross-sectional survey from 2018 to 2022 as part of the Indian Council of Medical Research–PCOS National Task Force study, with the primary aim of estimating the national prevalence of PCOS and regional phenotypic variations among women with PCOS. A multistage random sampling technique was adopted, and 7107 healthy women (aged 18-40 years) from 6 representative geographical zones of India were included in the study. The anthropometric indices and sociodemographic characteristics of these women were analyzed. Statistical analysis was performed to assess the association between exposure and outcome variables. Results Of the 7107 study participants, 3585 (50.44%) were from rural areas and 3522 (49.56%) were from urban areas. The prevalence of obesity increased from 8.1% using World Health Organization criteria to 40% using the revised consensus guidelines for Asian Indian populations. Women from urban areas showed higher proportions of overweight (524/1908, 27.46%), obesity (775/1908, 40.62%), and prehypertension (1008/1908, 52.83%) categories. A rising trend of obesity was observed with an increase in age. Women aged 18 to 23 years were healthy (314/724, 43.4%) and overweight (140/724, 19.3%) compared with women aged 36 to 40 years with obesity (448/911, 49.2%) and overweight (216/911, 23.7%). The proportion of obesity was high among South Indian women, with 49.53% (531/1072) and 66.14% (709/1072), using both World Health Organization criteria and the revised Indian guidelines for BMI, respectively. BMI with waist circumference and waist-to-height ratio had a statistically significant linear relationship (r=0.417; P&lt;.001 and r=0.422; P&lt;.001, respectively). However, the magnitude, or strength, of the association was relatively weak (0.3&lt;|r|&lt;0.5). Statistical analysis showed that the strongest predictors of being overweight or obese were older age, level of education, wealth quintile, and area of residence. Conclusions Anthropometric and sociodemographic characteristics are useful predictors of overweight- and obesity-related syndromes, including prehypertension, among healthy Indian women. Increased attention to the health of Indian women from public health experts and policy makers is warranted. The findings of this study can be leveraged to offer valuable insights, informing health decision-making and targeted interventions that mitigate risk factors of overweight, obesity, and hypertension. International Registered Report Identifier (IRRID) RR2-10.2196/23437
Indian Journal of Endocrinology and Metabolism, 2019
Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 diabetes mellitu... more Introduction: Dipeptidyl peptidase 4 (DPP4) inhibitors are widely used in type 2 diabetes mellitus (T2DM) patients but the data available in existing clinical trial programmes on DPP4 inhibitors include limited number of patients from India. Hence, this study attempted to understand usage, efficacy and safety of saxagliptin as first add-on after metformin in Indians with T2DM. Methodology: It was a multicenter, prospective, non-interventional and observational study planned to enrol T2DM patients who were inadequately controlled with metformin alone and had been recently (i.e., within past 15 days) prescribed saxagliptin as an add-on to metformin. Type 1 diabetes mellitus, use of glucose lowering drugs apart from metformin or saxagliptin, pregnancy, lactation, and medical condition, which could interfere with safe completion of the study were excluded. Results: A total of 1109 participants (658 men and 451 women) with mean ± SD age of 51.17 ± 11.85 years were enrolled from 50 centres throughout India. Significant reduction was observed in mean ± SD change of HbA1c as − 0.86% ± 1.76 from baseline to after 3 months of therapy (P < 0.0001). The quality of life assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire was reported to be “good” or “neither good nor bad” by majority of the participants at baseline and after 3 months of treatment. A total of 15 adverse events (AEs) were reported in the study, however, no serious adverse event (SAE) occurred during the study. All AEs were of mild intensity and did not require any intervention. Conclusion: Overall, saxagliptin in combination with metformin was generally well-tolerated in Indian T2DM patients and new or unexpected safety events were not identified. This study is also registered on Clinicaltrials.gov (NCT02588859).
Diabetes can affect the nervous system in several ways. Of all the neurological complications of ... more Diabetes can affect the nervous system in several ways. Of all the neurological complications of diabetes, peripheral neuropathy is by far the commonest and has been extensively studied. The involvement of central nervous system can be in several forms. The underlying damage may be due to involvement of the large and small cerebral blood vessels as also due to metabolic derangement caused by prolonged hypoglycemia, anoxia or ketoacidosis. The neurological emergencies that occur in diabetes can be: 1) atherothrombotic and lacunar strokes; 2) convulsive disorder in the setting of both hypo and hyperglycemia; 3) coma; 4) cranial neuropathies; and 5) acute proximal muscle weakness. In patients with diabetes, atherothrombotic stroke is associated with poor outcome. Hyperglycemia at the time of stroke is an important risk factor for an adverse outcome than chronic stable diabetic state. Proper management of diabetes in these acute situations is crucial for a better outcome of the underlying disease process.
Background Type 2 diabetes mellitus (T2DM) worldwide continues to increase, in particular in Indi... more Background Type 2 diabetes mellitus (T2DM) worldwide continues to increase, in particular in India. Early T2DM diagnosis followed by appropriate management will result in more cardiovascular event free life years. However, knowledge of the cardiovascular profile of newly diagnosed T2DM patients is still limited. The aim of this study was to understand the extent of cardiovascular disease (CVD) risk of newly diagnosed T2DM patients in India. Methods A cross sectional observational study was conducted to evaluate clinical laboratory and socio-demographic parameters of 5,080 newly diagnosed T2DM patients (48.3 ± 12.8 years of age; 36.7% female). In addition, we determined their cardiovascular risk according to the guidelines of the Lipid Association of India (LAI) and the criteria of the QRISK3 score. Results Of the newly T2DM diagnosed patients in India 2,007(39.5%) were classified as "High risk" and 3,073 (60.5%) were classified as "Very high risk" based on LAI criteria. On average, patients had 1.7 ± 0.9 major atherosclerotic cardiovascular disease (ASCVD) risk factors. Low HDL-C value was the most frequent major risk (2,823; 55.6%) followed by high age (2,502; 49.3%), hypertension (2,141; 42.1%), smoking/tobacco use (1,078; 21.2%) and chronic kidney disease stage 3b or higher (568; 11.2%). In addition, 4,192 (82.5%) patients appeared to have at least one cholesterol abnormality and, if the latest LAI recommendations are applied, 96.5% (4,902) presented with lipid values above recommended targets.
Aims-To evaluate whether and what combinations of diabetes quality metrics were achieved in a mul... more Aims-To evaluate whether and what combinations of diabetes quality metrics were achieved in a multicentre trial in South Asia evaluating a multicomponent quality improvement intervention that Correspondence to: Megha K. Shah.
There is a need for ideal basal insulin which can overcome the unmet need of a truly once daily i... more There is a need for ideal basal insulin which can overcome the unmet need of a truly once daily insulin, with a flat peakless profile. Useful for all types of patients Insulin degludec is next generation insulin with a unique mode of protraction of forming soluble multi-hexamers and slow continuous absorption giving it a flat profile compared to the existing basal insulin. In patients with type 1 diabetes or with type 2 diabetes, at steady-state, the mean terminal half-life of insulin degludec was 25 hours, i.e., approximately twice as long as for insulin glargine (half-life of 12.1 hours). In once-daily dosing regimen it reaches steady state after approximately 3 days. The duration of action of insulin degludec was estimated to be beyond 42 hours in euglycaemic clamp studies and this gives the unique opportunity of flexible time dosing which is not an available option with the existing basal insulin. The glucose-lowering effect is evenly distributed across a 24-hour dosing interval with insulin degludec having 4 times lower variability than insulin glargine. This is an important attribute given the narrow therapeutic window of insulin and the goal of achieving night time and inter-prandial glycaemic control without increasing the risk for hypoglycaemia, a goal that is challenging given the variability of absorption and lower PK half-lives of current basal insulin products. The combination of the ultra-long, flat and stable profile with an improved hour-to-hour and day-to-day variability could present an improved risk-benefit trade-off with the lower risk of hypoglycaemia, allowing for targeting improved levels of glycaemic control.
Indian Journal of Endocrinology and Metabolism, 2011
Hypothyroidism is a disorder commonly encountered in pregnancy. While thyroid antibodies are pres... more Hypothyroidism is a disorder commonly encountered in pregnancy. While thyroid antibodies are present in up to 15% of women in the reproductive age group, overt hypothyroidism is noted in 0.3-0.5% of all pregnancies, and subclinical hypothyroidism in 2-3%. [1] The pregnant woman presents a unique challenge, as well as an unparalleled opportunity, for the thyroidologist.
Indian Journal of Endocrinology and Metabolism, 2016
drugs which offer broad spectrum glucometabolic control, including glucose, blood pressure, weigh... more drugs which offer broad spectrum glucometabolic control, including glucose, blood pressure, weight, and lipid control, helps facilitate this process. We therefore suggest that the Law of Therapeutic Parsimony be included as a cardinal guiding principle of therapeutics in diabetology.
To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin ... more To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add-on to sodium-glucose co-transporter-2 (SGLT2) inhibitor therapy. Materials and methods: In this 26-week, phase IIIb, open-label, parallel-group, treat-to-target trial, conducted at 74 sites in 11 countries, insulin-naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53-97 mmol/mol (7.0-11.0%), body mass index 20-40 kg/m 2 and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once-daily IDegLira or IGlar U100, both as add-on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26. Results: A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%-points) with IDegLira and 18 mmol/mol (1.7%-points) with IGlar U100; confirming non-inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change-3.90 mmol/mol; 95% confidence interval [CI]-5.45;-2.35 (−0.36%-points; 95% CI-0.50,-0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference −1.92 kg; 95% CI-2.64,-1.19); severe or blood-glucose-confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference −15.37 U; 95% CI-19.60, −11.13). The overall treatment-emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates. Conclusions: The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population.
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Papers by Rakesh Sahay