Diabetes

A great prospect for type 1 diabetes

A great prospect for type 1 diabetes

Type 1 diabetes is a devastating life-long condition. It is autoimmune and frequently occurs in predisposed young adults. Chronic therapy is insulin use via multiple daily injections or insulin-pump; in addition to intensive lifestyle modifications.

The best management of type 1 diabetes is proactive prevention or elimination rather than reactive insulin usage. The current study addresses this very point. A group of 76 participants at high-risk for DM1 was randomized to receive teplizumab or placebo. The presence of autoantibodies to various entities such as GAD65, MicroIns, IA2, ICA, and ZnT8 defined the high-risk status.

Investigators followed subjects for six years. Remarkably at any point in time; teplizumab prevented the development of type 1 diabetes by about 60%. The annual rate of diagnosed diabetes was 16% vs. 39% in those treated with and without teplizumab.

Teplizumab is an immune modulator via CD3 co-receptor pathway. Treated patients experienced a higher rate of adverse events in the form of rash and temporary reduction in lymphocyte count.

I anticipate that further intense research on the subject will yield even higher rates of prevention in predisposed individuals. Family history and biochemical screening of patients would be parament. Stay tuned for similar research results as the DM1-prevention space is blossoming.

GT

Oral "ozempic" lowers A1c and body weight in patients with type 2 diabetes

Oral "ozempic" lowers A1c and body weight in patients with type 2 diabetes

PIONEER 1 was a 26-week randomized clinical trial conducted in nine countries. It tested the efficacy and safety of oral semaglutide vs. placebo in diabetes patients with baseline A1c 8.0%. A group of 703 adults was monitored and analyzed.

At 24 weeks, the higher dose 14 mg of oral semaglutide reduced A1c and body weight by about 1.2% and 5 lbs respectively. Results were statistically significant. Gastrointestinal side effects were more common with semaglutide than placebo but similar to other GLP-1 agonists in the market.

The above results are promising for oral semaglutide to receive FDA approval.

GT

Aspirin is useful in diabetes but increases the risk of bleeding

Aspirin is useful in diabetes but increases the risk of bleeding

The major randomized clinical trial, ASCEND, shows that aspirin 100 mg daily lowers the rates of cardiovascular events by 12% in patients with diabetes but increases the risk of bleeding by 30%.

A group of 15,000 participants with diabetes but without baseline CVD were followed for about 7 years.

Case by case clinical judgment would be key in evaluating CVD benefits vs. bleeding risks of aspirin use in patients with diabetes.

GT

Invokana protects the heart and kidneys

Invokana protects the heart and kidneys

Patients with type 2 diabetes receiving Invokana experienced 30% and 20% lower rates of kidney disease progression and cardiovascular events respectively, when compared to the placebo group.

Results were so obvious and significant that the study was terminated early. About 4500 subjects with DM2 were followed for about 2.5 years. No increased rates of fractures or amputations were seen with Invokana.

GT

Metformin found to be safe during pregnancy

Metformin found to be safe during pregnancy

The study found no major adverse events of metformin during pregnancy. This is good news as metformin is an important intervention for hyperglycemia of pregnancy. The following birth outcomes were assessed: cesarean section, neonatal weight, and serious neonatal adverse events.

GT

2019 Endocrine Society Guidelines: diabetes approach in older adults

2019 Endocrine Society Guidelines: diabetes approach in older adults


The Endocrine Society has just released its guidelines on how to manage the elderly with diabetes. Guidelines are overall similar to those of ADA and AACE but with greater emphasis in avoidance of adverse events such; as hypoglycemia, malnutrition, excessive weight loss, frailty, falls, and drug side effects. See below for more details.

GT

2019 AACE Guidelines: Diabetes Type 2 principles

2019 AACE Guidelines: Diabetes Type 2 principles

AACE standards were published in January 2019. They are a continual update of the original 2013 guidelines. Unlike ADA which recommends a general A1c target ≤7.0%, AACE promotes a tighter A1c goal of ≤6.5% for most patients with type 2 diabetes.

Recommendations also address lifestyle interventions, obesity, prediabetes, hypoglycemia, hypertension and dyslipidemia. Oral and injectable medications including insulin are discussed. A key priority is the avoidance of hypoglycemia — do no harm!

GT

Victoza use in children with diabetes type 2

Victoza use in children with diabetes type 2

Results of ELLIPSE trial are of major significance as they show that Victoza addition to Metformin helps in further reduction of A1c and fasting plasma glucose. The efficacy and safety appear to be similar as in adults. The most common side effects are gastrointestinal in nature. Based on ELLIPSE trial outcomes, I anticipate broadening of FDA indications for Victoza, to include children and adolescents

GT

Risk factors control is also important in type 1 diabetes

Risk factors control is also important in type 1 diabetes


This major observational study shows that the tight control of risk factors is associated with much lower rates of cardiovascular events and total mortality in patient with type 1 diabetes. Such factors are hyperglycemia, systolic blood pressure, protein in the urine, and the “bad” cholesterol (A1c, sBP, McAlb, LDLc).

This association has already been seen in adults with type 2 diabetes. For a practitioner, this study calls for a tight control of the above risk factors in patients with type 1 diabetes as in those with type 2. A group of 30,000 DM1 individuals were followed for about 10 years

GT

Red raspberries for breakfast

Red raspberries for breakfast

This simple study shows that frozen red raspberries in quantities of 125-250 mg (1-2 cups), when taken with a typical high-carb breakfast, improve insulin resistance in adults with prediabetes. Although these results would need to be validated, having red raspberries for breakfast sounds just right.

GT

Oral insulin 338 is effective but expensive

Oral insulin 338 is effective but expensive

This short phase 2 clinical trial shows that the oral insulin 338 improves fasting plasma glucose similar to the long-acting insulin glargine. Hypoglycemia rates are also similar. However, further studies of the oral insulin 338 are halted due to its need for high doses and cost. A group of 50 patients were followed for 8 weeks. The quest for the first oral insulin, nonetheless, continues.

GT

Addition of Ozempic to a SGLT2 inhibitor improves hyperglycemia and bodyweight

Addition of Ozempic to a SGLT2 inhibitor improves hyperglycemia and bodyweight

Clinical experience has consistently shown that addition of a GLP-1 agonist to a SGLT2 inhibitor improves hyperglycemia in patients with uncontrolled diabetes. Current study SUSTAIN 9 proves just that for semaglutide, a once weekly injectable GLP-1 agonist.

Addition of semaglutide reduced A1c by 1.4% and bodyweight by 8.4 lbs. Results were statistically significant. As expected, the GI side effects were more pronounced with semaglutide. About 72% of patients were also taking metformin and 13% sulfonylurea.

A group of 300 participants were followed for 30 weeks.

GT

Jardiance lowers blood pressure significantly in African American adults

Jardiance lowers blood pressure significantly in African American adults

Jardiance shows positive outcomes in African American adults. It reduces the A1c by 0.8%, body weight by 2.7 pounds and more interestingly the systolic blood pressure by 8 mmHg, similar to a standard blood pressure medication.

A group of 150 African American participants were randomized to receive Jardiance 25 mg daily or placebo for 6-months.

The SGLT2 inhibitor would be a great choice for patients with concomitant hyperglycemia and systolic hypertension.

GT

Newer diabetes medications also help prevent heart and kidney disease

Newer diabetes medications also help prevent heart and kidney disease

About 80,000 diabetes patients were analyzed from 8 clinical trials.

Authors found that GLP1 agonists and SGLT2 inhibitors prevented cardiovascular events (MACE) equally by 14% in those with established CVD. However, both classes of medications did not appear to be effective in reducing MACE in adults with diabetes but without established CVD.

SGLT2 inhibitors showed superior results compared to GLP1 agonists in regard to preventing hospitalizations for heart failure or severe kidney disease progression, such as end-stage-renal disease or death.

If cost, side effects, drug interactions and contraindications allow, diabetes patients would greatly benefit from these therapies on three fronts; glucose control, heart and kidney disease prevention.

GT

2018 Cholesterol Guidelines: Diabetes Mellitus

2018 Cholesterol Guidelines: Diabetes Mellitus

For diabetes patients, practical recommendations would be:

  • Start moderate-intensity statin therapy if:

    • Young — age 20-39 with microvascular complications or long-standing DM.

    • Older— age 40-75 without major risk factors.

  • Start high-intensity statin ± ezetimibe if the following factors are present with the goal of reducing LDLc ≥50%:

    • Multiple risk factors

    • ASCVD 10YR ≥20%

  • For adults >75, clinician-patient discussion is needed if statin were to be started or continued.

GT

Second line diabetes medication on the risk of CVD

Second line diabetes medication on the risk of CVD

Among patients with type 2 diabetes initiating second-line diabetes therapy, the short-term cardiovascular outcomes of GLP-1 receptor agonists, SGLT-2 inhibitors, and DPP-4 inhibitors were similar.

Higher cardiovascular risk was associated with use of sulfonylureas or basal insulin compared with newer drug classes.

Clinicians may consider prescribing GLP-1 receptor agonists, SGLT-2 inhibitors, or DPP-4 inhibitors more routinely after metformin rather than sulfonylureas or basal insulin.

JAMA

From diabetes to hyponatremia to osteoporosis

From diabetes to hyponatremia to osteoporosis

Patients with diabetes mellitus are at increased risk for bone fragility fracture secondary to multiple mechanisms.

Hyperglycemia can induce true dilutional hyponatremia. Hyponatremia is associated with gait instability, osteoporosis, and increased falls and bone fractures, and studies suggest that compromised bone quality with hyponatremia may be independent of plasma osmolality.

Analyses of this research support the hypothesis that hyponatremia is an additional risk factor for osteoporosis and fragility fracture among patients with diabetes mellitus.

JES

Statins improve diabetic retinopathy?

Statins improve diabetic retinopathy?

This major observational study suggests that statins reduce the risk of diabetic neuropathy, diabetic foot ulcers, and more importantly the risk of diabetic retinopathy. Risk reduction ranges from 10% to 45%. This could be due to statin-induced decreased microvascular inflammation. About 38,000 patients were followed for 7.5 years.

GT

Artificial pancreas in the hospital

Artificial pancreas in the hospital

The automated insulin pump has already shown great results in type 1 diabetes in an ambulatory setting. This study shows that it is as useful in type 2 diabetes patients treated in the hospital. Patients utilizing the “artificial pancreas” had better glycemic control, without an increased risk of hypoglycemia. I anticipate that closed-loop, automated insulin devices will become the “standard of care” for hospitalized patients with type 1 and type 2 diabetes in the future.

GT

Coffee and Diabetes

Coffee and Diabetes

About 4,000 adults ages 20-70 were followed for 6 years. Pre-diabetes and type 2 diabetes rates were lower in those who consumed coffee vs. non-consumers. Risk reduction on average was 30%. Nutritional benefits of coffee on insulin resistance are mounting, as shown in this article.

GT