Category Archives: Drugs for Diabetes

FDA Says Jardiance Can Claim Cardiovascular Death Prevention 

Jardiance is a diabetes drug in the class called SGLT2 inhibitors.

How do they work? Our kidneys filter glucose (sugar) out of our bloodstream, then reabsorb that glucose back into the bloodstream. SGLT2 inhibitors impair that reabsorption process, allowing some glucose to be excreted in our urine. You could call it a diuretic effect. For example, an SGLT 2 inhibitor called dapagliflozin, at a dose of 10 mg/day, causes the urinary loss of 70 grams of glucose daily.

How drugs like this could prevent cardiovascular disease in type 2 diabetics is a mystery to me.

From MPT:

“The diabetes drug empagliflozin (Jardiance) may be marketed for prevention of cardiovascular death in patients with type 2 diabetes and co-existing cardiovascular disease, the FDA said Friday.

It’s the first such claim ever allowed for a diabetes drug.

Empagliflozin, first approved in 2014, is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) pathway, reducing blood glucose by causing it to be excreted in urine.Its benefit for cardiovascular risk reduction was demonstrated in the so-called EMPA-REG trial, results of which were reported in 2015.”

Source: Jardiance Wins CV Prevention Indication | Medpage Today

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Benefits of T2D Triple Therapy Hold Up Over Time

“Treating newly diagnosed diabetes patients upfront with metformin/pioglitazone/exenatide therapy appeared to lower blood glucose and reduce hypoglycemic events better than standard sequential therapy, researchers reported here.

After 36 months of treatment, patients who were treated with the combination had a HbA1c of 5.8% compared with an HbA1c of 6.71% if they were treated with metformin, had a sulfonylurea added on and, then had basal insulin added (P<0.0001), according to Muhammed Abdul-Ghani, MD, PhD, at the University of Texas Health Science Center at San Antonio, and colleagues, in a poster presentation at the European Association for the Study of Diabetes.”

Source: EASD: Benefits of T2D Triple Therapy Hold Up Over Time | Medpage Today

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Insulin cost in U.S. doubled between 2002-2013

This is NOT an insulin rig!

This is NOT an insulin rig!

You can’t blame inflation for the cost increase. I’m not sure the link below explains why.

If you’re worried about the cost of insulin, you can take action today to reduce your required dose: lose the excess weight, eat fewer carbohydrates, improve your insulin sensitivity with exercise.

From Reuters:

“The cost of the hormone insulin, one of the most important treatments for diabetes, rose nearly 200 percent between 2002 and 2013, according to a new study.

While other diabetes medications also increased in price, total spending on insulin in 2013 was greater than the combined spending on all those other drugs, researchers report in JAMA.

“The large increase in costs can largely be explained (by) much greater use of newer types of insulin known as analog insulins,” said senior author Philip Clarke, of the University of Melbourne in Australia. “While these drugs can be better for some patients, they are much more costly than the human insulin they replaced.”

Source: Insulin cost in U.S. more than doubles between 2002-2013 | Reuters

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MannKind Corporation Starts New Marketing Campaign for Afrezza (inhaled insulin)

I first wrote about inhaled insulin in 2014. I have yet to run across a patient using it. In fact, I thought it may have been taken off the market for a while. In any case, it’s back:

“MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) announced it is now distributing MannKind-branded Afrezza® (insulin human) Inhalation Powder directly to major wholesalers and that Afrezza is available by prescription from retail pharmacies nationwide.  The MannKind-branded product is associated with new National Drug Code (NDC) numbers, as noted in the table below. With distribution channels now stocked, the Company announced several key programs to promote access, adoption and adherence to Afrezza therapy.”

Source: MannKind Corporation – Mannkind Assumes Responsibility for Distribution of Afrezza® and Launches Patient Reimbursement and Adherence Support Programs

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Diabetes Drugs: SGLT2 Inhibitor May Improve Kidney Health

I’m not sure I believe this, but here ya go:

“A new class of diabetes drugs can protect kidney health in addition to lowering blood sugar levels, study results suggest.

The findings, published August 18 in the Journal of the American Society of Nephrology, investigated the renal effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors, specifically canagliflozin, which reduce blood sugar by augmenting the excretion of glucose into urine.

“Since glycemic control is only modestly different between canagliflozin and glimepiride, our results suggest that potential kidney protective effects of canagliflozin may be unrelated to glycemic control,” the lead study author, Hiddo Lambers Heerspink, PhD, of the University Medical Center Groningen in the Netherlands, said in a statement.”

Source: New Diabetes Drugs May Also Improve Kidney Health | Medpage Today

PS: Even if these results are reproducible, remember that they may not apply to all drugs in the SGLT2 inhibitor class.

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Introducing Tresiba (insulin degludec): a New Long-Acting Basal Insulin

Tresiba joins other long-acting insulins like insulin glargine (Lantus), insulin detemir (Levemir), and good ol’ NPH insulin. It was approved by the U.S. Food and Drug Administration this year; it’s been used in other countries for longer. Insulin degludec will have different names depending on the country.

Who Is It For?

  • Adults with type 1 and 2 diabetes
  • Not for diabetic ketoacidosis
  • We have no good data on use in children (under 18), pregnant women, and nursing mothers

How Long Does It Work?

It will last for at least 30 hours in most users. After that, effectiveness starts to taper off but some effect may be seen as long as 42 hours after the injection.

What Is Its Role In Treating Diabetes?

Insulin degludec is a basal insulin, meaning that it runs in the background continuously. It’s not designed to reduce blood sugar that rises after a meal. If your pancreas still makes insulin, release of that insulin may reduce after-meal glucose levels adequately. Otherwise, after-meal glucose elevations are addressed with bolus insulin injections. Bolus-type insulins are the rapid-acting ones like Humalog and Novolog.

Most NPH insulin users, and some insulin glargine (Lantus) users, need the injection twice daily. Because of its long duration of action, Triseba users should never need more than one injection daily. I don’t have much experience with Levemir because the hospital where I work doesn’t stock it.

Triseba users should take it at about the same time daily. If you miss that time by up to five or six hours either way, it probably won’t matter.

What’s the Dose?

For type 2 diabetics who have never used insulin, the starting dose is typically 10 units/day.

For type 1’s switching from other insulins, the usual starting dose is one-third to one-half of the total daily insulin dose, plus rapid-acting bolus insulin around meal times for the remainder.

Change the dose no more often than every three or four days.

How Much Does It Cost?

I don’t know. Likely more than some of the other basal insulins.

Steve Parker, M.D.

PS: Click here for full prescribing information.

PPS: If words like glargine, degludec, and detemir turn your stomach, you’ll appreciate my book.

You'll not find "degludec" in here

You’ll not find “degludec” in here

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Over 10% of UK’s Drug Budget Goes for Diabetes Drugs

Here in the U.S., two of the top 10 prescribed drugs are diabetes drugs: Lantus and Januvia. That top 10 list is based on number of monthly prescriptions rather than revenue or cost.

Low Carb Diabetic has the details:

“The NHS in England spent £956.7m on drugs last year prescribed by GPs, nurses and pharmacists to treat and manage the condition. That sum represents 10.6% of the cost of all prescriptions issued by NHS primary care services in 2015-16.

The health service now spends more on medication for type 1 and type 2 diabetes than for any other ailment. The number of diabetics across the UK as a whole has recently risen to more than four million and has increased by 65% over the last 10 years.”

 

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Pre-Mixed Insulins May Not Be Right For You

Kelly Pounds, RN, CDE, has a brief post on the problems of pre-mixed insulins. By pre-mixed, I mean something like Novolin 70/30, which is 70% intermediate-acting insulin and 30% regular insulin. Another common product is 75/25.

Click the link below for details.

“Mixed insulins can have their place.  For instance, they are ideal for those that can only afford one vial of insulin at a time.  Or for those with limited abilities in calculating and managing their insulin doses.  They may be ideal for those that are advanced in years or those with limited dexterity, limited understanding, or even vision problems (people that may mix up insulin vials if they have more than one.)  However, if you are not bound these types of circumstances, you may consider a different, more effective regimen.”

Source: Problems With Mixed Insulin Therapy – Low Carb RN (CDE)

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FDA Approves Another GLP-1 Receptor Agonist Drug for Type 2 Diabetes

The most common side effects are nausea, vomiting, diarrhea, headaches, and dizziness.

“The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.

”Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.”

Source: Press Announcements > FDA approves Adlyxin to treat type 2 diabetes

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No Clear Survival Differences Seen Between Diabetes Drugs

"How about this one?"

“How about this one?”

A multinational group of researchers tried to determine which drugs for type 2 diabetes were better at prolonging life and preventing cardiovascular deaths. They reviewed the existing literature (i.e., they did a meta-analysis of prior clinical studies.

There are no clear winners. Placebo worked as well as the eight drug classes examined!

Unfortunately, the abstract doesn’t say how long the clinical studies lasted, only mentioning that they were at least 24 weeks long. It’s quite possible it would take at least three to five years to see an effect on death rates.

Click the source link at the bottom of the page for details at MPT.

Selected quotes:

“Eight different diabetes drug classes examined in a meta-analysis failed to demonstrate improved cardiovascular or all-cause mortality compared with placebo.Researchers analyzed 301 randomized clinical trials of patients with type 2 diabetes, and found that, metformin outperformed some other drug classes for its effect on hemoglobin A1c levels, there were no significant differences in mortality — including when placebo was included as a drug class.”

***

“A central finding in this meta-analysis was that despite more than 300 available clinical trials involving nearly 120,000 adults and 1.4 million patient-months of treatment, there was limited evidence that any glucose-lowering drug stratified by coexisting treatment prolonged life expectancy or prevented cardiovascular disease,” the authors wrote.”

***

“The authors wrote that their findings are consistent with guidelines from the American Diabetes Association, which — like the algorithm from the American Association of Clinical Endocrinologists — recommend that metformin monotherapy be used for the initial treatment of patients with type 2 diabetes. “Based on this review, clinicians and patients may prefer to avoid sulfonylureas or basal insulin for patients who wish to minimize hypoglycemia, choose GLP-1 receptor agonists when weight management is a priority, or consider SGLT-2 inhibitors based on their favorable combined safety and efficacy profile,” the authors wrote.”

Source: No Clear Survival Benefit Seen Among Diabetes Drugs | Medpage Today

Open wide!

Open wide!

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