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RCT: No difference in ICU length of stay or 90-day mortality between tight and liberal glucose control

2 Oct, 2023 | 11:25h | UTC

Study Design and Population: This randomized controlled trial assessed the effects of tight versus liberal glucose control on the length of ICU stay in critically ill patients. A total of 9,230 patients were included, with 4,622 in the liberal-control group (insulin initiation when blood glucose levels exceeded 215 mg/dL) and 4,608 in the tight-control group (blood glucose targeted between 80 and 110 mg/dL). In both groups, parenteral nutrition was withheld during the first week of ICU admission. The primary endpoint was the duration of ICU stay, and 90-day mortality served as a key safety outcome.

Main Findings: No significant differences were observed in the primary endpoint, the length of ICU stay, between the two groups (hazard ratio 1.00; 95% CI, 0.96 to 1.04; P=0.94). The 90-day mortality rates were also similar (10.1% in the liberal-control group vs. 10.5% in the tight-control group, P=0.51). Incidences of severe hypoglycemia were low and statistically similar in both groups (1.0% in the tight-control group vs. 0.7% in the liberal-control group). Secondary outcomes, including new infections and the duration of respiratory and hemodynamic support, showed no significant differences. However, lower incidences of severe acute kidney injury and cholestatic liver dysfunction were observed in the tight-control group.

Implications & Limitations: The study supports existing evidence that tight glucose control doesn’t provide substantial benefits in reducing ICU stay duration or mortality. This suggests that a more liberal approach to glucose control may be preferable in most ICU settings, especially to minimize hypoglycemia risk. Key limitations of the study include its narrow focus on the absence of early parenteral nutrition, which could limit generalizability, and the inability to blind caregivers to treatment assignments. Future research should investigate the impact of tight glucose control in various patient subgroups and under different nutritional conditions.

Article: Tight Blood-Glucose Control without Early Parenteral Nutrition in the ICU – New England Journal of Medicine


Presented at ASRS Meeting | Studies link GLP-1 agonists to progression of diabetic retinopathy

11 Aug, 2023 | 15:38h | UTC

Studies link GLP-1 agonists to progression of diabetic retinopathy – MDedge


Multinational Study | No correlation between Covid-19 and onset of type 1 diabetes in children

8 Aug, 2023 | 13:32h | UTC

SARS-CoV-2 — No Increased Islet Autoimmunity or Type 1 Diabetes in Teens – New England Journal of Medicine


Cohort Study | Habitual calcium supplementation linked to higher CVD incidence and mortality in diabetics

8 Aug, 2023 | 13:24h | UTC

Associations of Habitual Calcium Supplementation With Risk of Cardiovascular Disease and Mortality in Individuals With and Without Diabetes – Diabetes Care (link to abstract – $ for full-text)

Related: The Evidence and Controversy Between Dietary Calcium Intake and Calcium Supplementation and the Risk of Cardiovascular Disease: A Systematic Review and Meta-Analysis of Cohort Studies and Randomized Controlled Trials – Journal of the American College of Nutrition


Commentary on Twitter


Do-it-yourself automated insulin delivery: a health-care practitioner user’s guide

7 Aug, 2023 | 14:44h | UTC

Do-It-Yourself Automated Insulin Delivery: A Health-care Practitioner User’s Guide – Canadian Journal of Diabetes


Review | Diabetes of the exocrine pancreas: implications for pharmacological management

7 Aug, 2023 | 14:25h | UTC

Diabetes of the Exocrine Pancreas: Implications for Pharmacological Management – Drugs


Cohort Study | Exploring the potential impact of artificial sweeteners on type 2 diabetes risk

28 Jul, 2023 | 14:07h | UTC

Artificial Sweeteners and Risk of Type 2 Diabetes in the Prospective NutriNet-Santé Cohort – Diabetes Care


Cohort Study | More data suggests SGLT-2 inhibitors could reduce gout flares

26 Jul, 2023 | 13:24h | UTC

Comparative Effectiveness of Sodium–Glucose Cotransporter-2 Inhibitors for Recurrent Gout Flares and Gout-Primary Emergency Department Visits and Hospitalizations: A General Population Cohort Study – Annals of Internal Medicine (link to abstract – $ for full-text)


SGLT-2 inhibitors reduced gout flares in patients with diabetes, gout – ACP Internist

SGLT2i Use Linked to Reduced Risk for Flare in Adults With Gout, T2D – HealthDay

SGLT2 inhibitors linked with fewer gout flares in diabetes – MDedge


Guideline | Laboratory analysis in the diagnosis and management of diabetes mellitus

21 Jul, 2023 | 13:50h | UTC

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus – Diabetes Care

Executive Summary: Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus – Diabetes Care


Review | Painful diabetic peripheral neuropathy

20 Jul, 2023 | 10:53h | UTC

Painful Diabetic Peripheral Neuropathy: Practical Guidance and Challenges for Clinical Management – Diabetes, Metabolic Syndrome and Obesity


RCT | Metformin boosts effectiveness of lifestyle interventions for diabetes prevention in individuals with impaired glucose regulation

13 Jul, 2023 | 13:07h | UTC

Safety and effectiveness of metformin plus lifestyle intervention compared with lifestyle intervention alone in preventing progression to diabetes in a Chinese population with impaired glucose regulation: a multicentre, open-label, randomised controlled trial – The Lancet Diabetes & Endocrinology (link to abstract – $ for full-text)

Related Study: Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin – New England Journal of Medicine (link to abstract – $ for full-text)


Single Arm Trial | Low-carbohydrate diet improves glycemic control in type 1 diabetes

13 Jul, 2023 | 13:04h | UTC

Effects of a low-carbohydrate diet in adults with type 1 diabetes management: A single arm non-randomised clinical trial – PLOS One


Management of Type 1 Diabetes With a Very Low–Carbohydrate Diet – Pediatrics (link to abstract – $ for full-text)

Meta-analysis of randomized trials: patients adhering to a low carbohydrate diet for six months may experience remission of diabetes without adverse consequences

RCT | A calorie-unrestricted low-carbohydrate, high-fat diet resulted in short-term weight loss and better glycemic control.

Comparison of the Effectiveness of Low Carbohydrate Versus Low Fat Diets, in Type 2 Diabetes: Systematic Review and Meta-Analysis of Randomized Controlled Trials – Nutrients

Consensus Statement: Effect of carbohydrate-restricted diets and intermittent fasting on obesity, type 2 diabetes mellitus, and hypertension management.

Effects of a 6-month, low-carbohydrate diet on glycaemic control, body composition, and cardiovascular risk factors in patients with type 2 diabetes: An open-label randomized controlled trial – Diabetes, Obesity and Metabolism

Lower carbohydrate diets for adults with type 2 diabetes – British Journal of Nutrition

Low carbohydrate diet: Insights from a general practice service in patients with type 2 diabetes

Diabetes Canada Position Statement on Low-Carbohydrate Diets for Adults With Diabetes: A Rapid Review – Canadian Journal of Diabetes

Low Carbohydrate Diets for Diabetes: A Review of the Clinical Effectiveness and Guidelines – Canadian Agency for Drugs and Technologies in Health

Adapting diabetes medication for low carbohydrate management of type 2 diabetes: a practical guide – British Journal of General Practice


RCT | Weekly Tirzepatide outperforms placebo in weight management for type 2 diabetes patients

7 Jul, 2023 | 16:24h | UTC

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)

Commentary: Tirzepatide triumphs in significant weight reduction for people with type 2 diabetes – News Medical


Review | Cardiovascular outcomes in patients with diabetes and kidney disease

7 Jul, 2023 | 16:13h | UTC

Cardiovascular Outcomes in Patients With Diabetes and Kidney Disease: JACC Review Topic of the Week – Journal of the American College of Cardiology


Review | Diabetes detection in women with gestational diabetes and polycystic ovarian syndrome

7 Jul, 2023 | 16:08h | UTC

Diabetes detection in women with gestational diabetes and polycystic ovarian syndrome – The BMJ


ASA Consensus Guidance | Preoperative management of patients on GLP-1 agonists

5 Jul, 2023 | 01:17h | UTC

American Society of Anesthesiologists Consensus-Based Guidance on Preoperative Management of Patients (Adults and Children) on Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists – American Society of Anesthesiologists

Commentary: Anesthesiologists Say Ozempic, Wegovy Should Be Halted Prior to Surgery – HealthDay


RCT | Weekly insulin Icodec proves effective in glucose control in insulin-naive type 2 diabetes patients

3 Jul, 2023 | 14:32h | UTC

Summary: The ONWARDS 3 randomized clinical trial studied the efficacy of once-weekly insulin icodec in comparison to once-daily insulin degludec for glucose control in insulin-naive type 2 diabetes patients. The double-masked, double-dummy trial was conducted from March 2021 to June 2022 across 92 sites in 11 countries, enrolling 588 adults with type 2 diabetes. The participants were randomly divided into two groups: 294 receiving once-weekly icodec and daily placebo, and 294 receiving daily degludec and weekly placebo.

The primary endpoint was the change in Hemoglobin A1c (HbA1c) from baseline to week 26. Insulin icodec showed a noninferior HbA1c change from the baseline (-1.6 percentage points) compared to insulin degludec (-1.4 percentage points) and demonstrated confirmed statistical superiority. However, the trial showed a higher rate of combined level 2 (clinically significant) or level 3 (severe) hypoglycemic events in the insulin icodec group than in the insulin degludec group, despite the overall low rates in both groups. There was no significant difference in weight changes between the two groups.

The study concluded that once-weekly insulin icodec demonstrated superior HbA1c reduction compared to once-daily degludec after 26 weeks of treatment in insulin-naive type 2 diabetes patients. The convenience of once-weekly administration should be considered against the slightly higher absolute risk of hypoglycemia. The study’s limitations include its short duration (26 weeks) and a lack of data on sustained effects, patient-reported outcomes, and continuous glucose monitoring.

Article: Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial – JAMA (link to abstract – $ for full-text)

See also: Visual Abstract

Related Study: Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin – New England Journal of Medicine (link to abstract – $ for full-text)


Open-label RCT | Weekly insulin Icodec proves noninferior to daily Glargine in type 2 diabetes

3 Jul, 2023 | 14:23h | UTC

Weekly Icodec versus Daily Glargine U100 in Type 2 Diabetes without Previous Insulin – New England Journal of Medicine (link to abstract – $ for full-text)

Related Study: Once-Weekly Insulin Icodec vs Once-Daily Insulin Degludec in Adults With Insulin-Naive Type 2 Diabetes: The ONWARDS 3 Randomized Clinical Trial – JAMA (free for a limited period)


M-A | Effects of SGLT-2 inhibitors on adipose tissue distribution in patients with type 2 diabetes mellitus

30 Jun, 2023 | 14:47h | UTC

Effects of SGLT-2 inhibitors on adipose tissue distribution in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials – Diabetology & Metabolic Syndrome

Related: Effect of SGLT-2 inhibitors on body composition in patients with type 2 diabetes mellitus: A meta-analysis of randomized controlled trials – PLOS One


Phase 2 RCT | Triple-hormone-receptor (GIP, GLP-1, and glucagon) agonist Retatrutide substantially reduces body weight in obesity

28 Jun, 2023 | 13:23h | UTC

Summary: This Phase 2, double-blind, randomized, placebo-controlled trial evaluated the efficacy and safety of Retatrutide, a triple-hormone-receptor agonist of GIP, GLP-1, and glucagon, for obesity treatment. The study recruited 338 adults, predominantly male, with a Body Mass Index (BMI) of 30 or higher, or 27 to 30 with at least one weight-related condition. Participants were administered subcutaneous Retatrutide at varying doses or a placebo, once weekly for 48 weeks.

The findings indicate a dose-dependent weight loss efficacy for Retatrutide. At 24 weeks, Retatrutide users exhibited a mean body weight decrease ranging from 7.2% (1 mg dose) to 17.5% (12 mg dose), compared to a 1.6% reduction in the placebo group. This effect was even more pronounced at 48 weeks, with changes ranging from 8.7% (1 mg dose) to a striking 24.2% (12 mg dose), contrasted with a 2.1% reduction in the placebo group. Adverse events, primarily gastrointestinal, were common with Retatrutide, reported by 73 to 94% of patients, and were dose-related.

Retatrutide demonstrated substantial body weight reduction in adults with obesity, with a side effects profile similar to existing GLP-1 and GIP–GLP-1 receptor agonists. These promising results warrant further investigation through a Phase 3 trial to further ascertain the safety and efficacy of Retatrutide in obesity treatment.

Article: Triple–Hormone-Receptor Agonist Retatrutide for Obesity — A Phase 2 Trial – New England Journal of Medicine (link to abstract – $ for full-text)


Commentary on Twitter


Phase 2 RCT | Triple receptor agonist (GIP, GLP-1 and glucagon) Retatrutide shows promising results in obese patients with T2DM

28 Jun, 2023 | 13:21h | UTC

Summary: A Phase 2 Randomized Clinical Trial (RCT) was conducted to investigate the efficacy and safety of Retatrutide, a glucose-dependent insulinotropic polypeptide (GIP), GLP-1, and glucagon receptor agonist, in patients with type 2 diabetes. The study involved 281 adults aged between 18 and 75 years with type 2 diabetes. These patients, with a mean HbA1c level of 8·3%, a mean BMI of 35·0 kg/m², and a mean body weight of 98·2 kg, were randomized to Retatrutide at various doses, Dulaglutide 1.5 mg, and placebo. Patients were treated with diet and exercise alone or a stable dose of metformin for at least three months prior to the study.

The primary outcomes revealed that at 24 weeks, participants who received the higher doses of Retatrutide demonstrated substantial improvements in HbA1c compared to the placebo group and those who received Dulaglutide. Specifically, for the highest-dose Retatrutide group (12 mg), HbA1c level was reduced by an average of 2.02%, which was significantly greater compared to a reduction of 0.01% in the placebo group and 1.41% in the Dulaglutide group.

Regarding body weight, at 36 weeks, participants receiving the different doses of Retatrutide showed a dose-dependent decrease: 3.19% for the 0.5 mg group, 7.92% for the 4 mg escalation group, 10.37% for the 4 mg group, 16.81% for the 8 mg slow escalation group, 16.34% for the 8 mg fast escalation group, and 16.94% for the 12 mg escalation group. This was significantly higher compared to the 3.00% weight loss in the placebo group and the 2.02% loss with 1.5 mg Dulaglutide.

Mild-to-moderate gastrointestinal adverse events were reported among 35% of the participants in the Retatrutide groups, similar to those in the Dulaglutide group, and no severe hypoglycemia or deaths were reported.

The implications of these findings suggest that Retatrutide provides clinically meaningful improvements in glycaemic control and bodyweight reduction with a safety profile consistent with GLP-1 receptor agonists and GIP and GLP-1 receptor agonists. Limitations of the study include limitation of this study is the relatively short duration of the trial and small sample size. Long-term effects and safety of Retatrutide remain to be evaluated in further studies.

Article: Retatrutide, a GIP, GLP-1 and glucagon receptor agonist, for people with type 2 diabetes: a randomised, double-blind, placebo and active-controlled, parallel-group, phase 2 trial conducted in the USA – The Lancet (link to abstract – $ for full-text)


RCT | Oral Semaglutide at 25mg and 50mg improves glycemic control in overweight T2DM patients compared to standard 14mg dose

27 Jun, 2023 | 13:58h | UTC

Summary: The study was a global, multicenter, randomized, double-blind, phase 3b trial involving 1606 adults with inadequately controlled type 2 diabetes. The mean HbA1c in the study population was 9.0% and the mean BMI was 33.8 kg/m2. Participants were assigned to receive either 14mg, 25mg, or 50mg of once-daily oral semaglutide for 68 weeks. The trial aimed to investigate the effectiveness of a new formulation of semaglutide at higher investigational doses against the standard 14mg dose.

The primary endpoint was the change in glycated hemoglobin (HbA1c) levels from baseline to week 52. Results showed that at week 52, changes in HbA1c levels were significantly more substantial with the 25mg (-1.8 percentage points) and 50mg (-2.0 percentage points) doses compared to the 14mg dose (-1.5 percentage points). During the trial, ten deaths occurred, but none were considered treatment-related. No new safety concerns were identified, though adverse events, primarily mild to moderate gastrointestinal disorders, were slightly more frequent in the 25mg and 50mg groups.

The study limitations include a relatively short exposure to the higher doses due to the up to 16 weeks of dose-escalation period, non-adjustable doses due to masking requirements, and a cohort predominantly of White ethnicity, considering the high prevalence of type 2 diabetes in other racial groups. The study was unable to assess differences in efficacy and tolerability between the 25mg and 50mg doses, raising the question of whether the 50mg dosage is necessary if similar effects can be achieved with the 25mg dose.

The implications for further research highlight the need for real-world studies to investigate the clinical impact and safety of these higher doses of oral semaglutide. The superior glycemic control and bodyweight loss with oral semaglutide 25mg and 50mg suggest that these higher doses might help individualize treatment goals and intensify treatment by increasing the dose of a single oral agent. Future studies could consider comparing the 25mg and 50mg doses more directly to determine the most effective and tolerable dose for patients.

Article: Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial – The Lancet (free registration required)


RCT | Once-daily oral Semaglutide 50mg outperforms placebo in obesity treatment

27 Jun, 2023 | 13:57h | UTC

Summary: The referenced study is a phase 3, superiority, randomized, double-blind, placebo-controlled trial that investigated the effectiveness of oral semaglutide 50mg in treating overweight and obese adults without type 2 diabetes. The trial was conducted in 50 outpatient clinics across Asia, Europe, and North America, with a total of 667 participants randomly allocated to receive either the treatment or a placebo.

The primary outcome measured was the percentage change in bodyweight from baseline to week 68. Results showed a significant reduction in bodyweight among participants receiving semaglutide – a mean change of -15.1% compared to -2.4% for placebo recipients. Additionally, a higher percentage of semaglutide recipients achieved weight reductions of at least 5%, 10%, 15%, and 20% compared to placebo recipients.

However, it’s important to note that adverse events were more frequently observed in the semaglutide group. Specifically, 80% of participants receiving oral semaglutide 50 mg experienced gastrointestinal adverse events, mostly mild to moderate, compared to 46% in the placebo group. This highlights the need for careful patient monitoring during treatment.

The findings indicate that oral semaglutide 50mg, when taken once daily, can lead to a clinically meaningful decrease in bodyweight among overweight and obese adults without type 2 diabetes. Despite the higher occurrence of gastrointestinal adverse events, the significant weight loss potential positions oral semaglutide as a promising treatment option. Further research is recommended to establish long-term safety and efficacy.

Article: Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial – The Lancet (link to abstract – $ for full-text)


Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050

26 Jun, 2023 | 01:00h | UTC

Summary: This systematic review analyzed the global burden of diabetes, including trends, projections, and attributions to risk factors. It considered data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), covering 204 countries and territories.

In 2021, an estimated 529 million people worldwide were living with diabetes. Regionally, the highest rates were observed in North Africa, the Middle East, and Oceania. Type 2 diabetes accounted for 96% of diabetes cases and 95.4% of diabetes DALYs (disability-adjusted life-years). More than half of global type 2 diabetes DALYs were attributable to high body mass index (BMI).

Predictions suggest that more than 1.31 billion people will have diabetes by 2050, with high prevalence rates in North Africa, the Middle East, and Latin America. The study notes the ongoing challenge of preventing and controlling type 2 diabetes, largely driven by increasing obesity. An understanding of disparities in risk profiles and disease burdens can inform strategies to control diabetes risk factors.

Article: Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021 – The Lancet

Editorial: Diabetes: a defining disease of the 21st century – The Lancet

News Release: Global diabetes cases to soar from 529 million to 1.3 billion by 2050 – Institute for Health Metrics and Evaluation


Commentary on Twitter (thread – click for more)


Phase 2 RCT | Oral GLP-1 agonist Orforglipron outperforms dulaglutide and placebo in type 2 diabetes control

26 Jun, 2023 | 00:54h | UTC

Summary: In a 26-week, phase 2, double-blind, randomized trial spanning multiple centers in the USA, Hungary, Poland, and Slovakia, researchers examined the efficacy and safety of orforglipron, a non-peptide GLP-1 receptor agonist. The sample comprised 383 adults aged 18 and older with type 2 diabetes treated with diet and exercise, with or without metformin, and with a glycated hemoglobin (HbA1c) of 7.0–10.5%.

The study’s primary efficacy outcome revealed that orforglipron achieved a significantly higher mean reduction in HbA1c compared to both the placebo and dulaglutide (-2.10% vs -0.43% and -1.10%, respectively). Furthermore, orforglipron induced a change in mean body weight at week 26 of -10.1 kg, outperforming both the placebo and dulaglutide. Adverse events mostly encompassed mild to moderate gastrointestinal issues.

The study concluded that orforglipron at doses of 12 mg or higher could potentially serve as an effective alternative to injectable GLP-1 receptor agonists and oral semaglutide, for type 2 diabetes treatment. While the drug’s safety profile was consistent with other GLP-1 receptor agonists, there is a need for larger confirmatory studies and dose regimen optimization.

Article: Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study – The Lancet (link to abstract – $ for full-text)

Commentary: Orforglipron Shows Promise as Weight Loss, Diabetes Agent in Phase 2 Trials – HCP Live


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