Category Archives: Drugs for Diabetes

Mediterranean Diet Reduces Need For Diabetes Medications

diabetic mediterranean diet, Steve Parker MD

Pharmacist counting pills

From Diabetes Care:

OBJECTIVE

To examine the effects of two Mediterranean eating plans (Med-EatPlans) versus a low-fat eating plan on the need for glucose-lowering medications.

RESEARCH DESIGN AND METHODS

From the Prevención con Dieta Mediterránea (PREDIMED) trial, we selected 3,230 participants with type 2 diabetes at baseline. These participants were randomly assigned to one of three eating plans: Med-EatPlan supplemented with extra-virgin olive oil (EVOO), Med-EatPlan supplemented with mixed nuts, or a low-fat eating plan (control). In a subgroup (15%), the allocation was done in small clusters instead of using individual randomization, and the clustering effect was taken into account in the statistical analysis. In multivariable time-to-event survival models, we assessed two outcomes: 1) introduction of the first glucose-lowering medication (oral or injectable) among participants on lifestyle management at enrollment and 2) insulin initiation.

RESULTS

After a median follow-up of 3.2 years, in multivariable analyses adjusting for baseline characteristics and propensity scores, the hazard ratios (HRs) of starting a first glucose-lowering medication were 0.78 (95% CI 0.62–0.98) for Med-EatPlan + EVOO and 0.89 (0.71–1.12) for Med-EatPlan + nuts, compared with the control eating plan. After a median follow-up of 5.1 years, the adjusted HRs of starting insulin treatment were 0.87 (0.68–1.11) for Med-EatPlan + EVOO and 0.89 (0.69–1.14) for Med-EatPlan + nuts compared with the control eating plan.

CONCLUSIONS

Among participants with type 2 diabetes, a Med-EatPlan + EVOO may delay the introduction of new-onset glucose-lowering medications. The Med-EatPlan did not result in a significantly lower need for insulin.

Source: Effects of a Mediterranean Eating Plan on the Need for Glucose-Lowering Medications in Participants With Type 2 Diabetes: A Subgroup Analysis of the PREDIMED Trial | Diabetes Care

Steve Parker, M.D.

low-carb mediterranean diet

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Is Cinnamon a Legitimate Treatment for Diabetes?

What type of cinnamon is this?

Be aware that there are several types of cinnamon.

Pharmacist Scott Gavura writes at Science Based Medicine:

Given the consequences of diabetes, self-management is something I want to encourage, not discourage. Without a commitment from the patient to take an active role in managing their diabetes, any treatment plan is doomed to fail. So is self-treatment with dietary supplements a wise idea? There’s an array available, and patients regularly ask about the latest treatment “Big Pharma doesn’t want you to know about”. That treatment used to be chromium. Ginseng was popular for a time, too. Fenugreek and bitter melon are used as well. One of the most persistently popular treatments is cinnamon. Like any other herbal remedy, most sources will tell you that it’s been used for “thousands of years” as a medicinal herb. As a treatment for diabetes, I have my doubts. While reports of diabetes go back to 1552 BCE, the ability to measure the effectiveness of any diabetes treatment only goes back a few decades. Interest in cinnamon as a treatment seems to have started with in vitro tests but gained some plausibility in 2003, when a study from Alam Khan suggested several grams of cassia cinnamon per day could lower fasting blood glucose. Khan randomized Type 2 diabetes to 1g, 3g, or 6g of cinnamon for 40 days. All three groups improved their fasting blood glucose, and blood lipid levels, but there was no effect on A1C.Like trials with any other supplement or herbal product, the primary question we must answer is “What exactly was studied?” The cinnamon you have in your kitchen may be a single species of plant or a mix of different cultivars. Ceylon cinnamon (Cinnamommum verum) is more commonly found in the West. Cassia cinnamon (Cinnamomum aromaticum) is the version of cinnamon that’s been studied in trials. The chemical hydroxychalcone has been identified as a potential active ingredient, which is believed to modify the sensitivity of cells to insulin, enhancing their uptake. If that’s the true mechanism of action, then it would work in a manner similar to that of the drugs Avandia, Actos, and metformin (Glucophage). Given the active ingredient (or ingredients) have not yet been definitively isolated, the issue of studying cinnamon is problematic. There’s no way to assess the potency of any batch, which complicates any evaluation. And that may be a reason why the research with cinnamon is inconsistent, and on balance, not impressive.

While the Khan study looked promising, supplementary studies have failed to consistently show beneficial effects.

Source: How effectively does cinnamon treat diabetes? – Science-Based Medicine

Steve Parker, M.D.

low-carb mediterranean diet

Click the pic to purchase at Amazon.com. E-book versions also available at Smashwords.com.

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Cross the Border for Affordable Insulin

Great article by Robin Cressman. Read the whole thing.

“Just a week before the trip [to Tijuana, Mexico], I was down to my very last vial of Humalog. It was June and I was close, but still so far, from hitting my $5,000 deductible for the year, which meant I was still paying full price out of pocket for all of my medical costs until I hit that figure. I had started the year low on supplies (a rookie mistake that I now know to avoid) and had been juggling bills from Dexcom, my doctor’s office, and my pump supplier for months, trying to only use our health savings account but often having to pull out credit cards to cover the costs. I called my pharmacy and asked to fill a single vial of Humalog, and the cost was $248.13. I hung up the phone. Instead I went to Walmart and for the first time bought vials of Novolin NPH and Regular for $24.99 each. It was those vials that were serving as my backup insulin a week later when I found myself in that pharmacy in Tijuana.”

Source: Crossing Borders to Afford Insulin – T1International

Whether it’s legal or not, I don’t know.

Steve Parker, M.D.

low-carb mediterranean diet

Click the pic to purchase at Amazon.com in the U.S. E-book versions also available at Smashwords.com.

 

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FDA warns doctors  about rare occurrences of a serious infection of the genital area with SGLT2 inhibitor drugs

The infection is called Fournier Gangrene. It’s a nasty infection that I’ve seen only a few times, always in men. The FDA reports cases in both men and women taking SGLT2 inhibitors to treat their diabetes.

“Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.”

Source: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes | FDA

Steve Parker, M.D.

PS: With the right diet, you’ll need fewer drugs to control your diabetes. So, fewer drug side effects and less expense.

low-carb mediterranean diet

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Do Nutritional Supplements Help Control Diabetes?

From Diabetes Care

“The routine use of chromium or vitamin D micronutrient supplements or any herbal supplements, including cinnamon, curcumin, or aloe vera, for improving glycemia in people with diabetes is not supported by evidence and is therefore not recommended.”

Source: Nutrition Therapy for Adults With Diabetes or Prediabetes: A Consensus Report | Diabetes Care

Did Big Pharma pay for this article in Diabetes Care?

Steve Parker, M.D.

PS: The Low-Carb Mediterranean Diet typically reduces or eliminates the need for drugs or supplements to control diabetes.

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From 2003: Oral Magnesium Supplementation Improves Insulin Sensitivity and Metabolic Control in Type 2 Diabetes

Not the magnesium used in the study at hand

The study was done in northern Mexico and all participants were taking glibenclamide, a sulfonylurea known as glyburide in the U.S. Importantly, study participants had low blood magnesium levels at the outset.

So if you’re not a hypomagnesemic Mexican taking glibenclamide, results may not apply to you.

Nevertheless, results were impressive. Compared to the control group, magnesium supplementation…

  • reduced insulin resistance
  • fasting glucose was 144 mg/dl (185 in controls)
  • Hemoglobin A1c was 8% (10% in controls)

The experiment lasted 16 weeks and the specific form of magnesium used was magnesium chloride solution.

Maybe we should be checking magnesium levels more often. BTW, magnesium supplements are difficult for our bodies to absorb. I know of at least three magnesium compounds: oxide, citrate, and chloride. There are probably others. Degree of absorption varies from one to the other. Adding a supplement on top of kidney impairment could cause toxicity.

The researchers conclude:

Oral supplementation with MgCl2 solution restores serum magnesium levels, improving insulin sensitivity and metabolic control in type 2 diabetic patients with decreased serum magnesium levels.

Source: Oral Magnesium Supplementation Improves Insulin Sensitivity and Metabolic Control in Type 2 Diabetic Subjects | Diabetes Care

low-carb mediterranean diet

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Management of Type 1 Diabetes With a Very Low–Carbohydrate Diet 

diabetic diet, low-carb mediterranean diet

Long-term diabetes management begins in the kitchen

From the medical journal Pediatrics:

“Abstract

OBJECTIVES: To evaluate glycemic control among children and adults with type 1 diabetes mellitus (T1DM) who consume a very low–carbohydrate diet (VLCD).

METHODS: We conducted an online survey of an international social media group for people with T1DM who follow a VLCD. Respondents included adults and parents of children with T1DM. We assessed current hemoglobin A1c (HbA1c) (primary measure), change in HbA1c after the self-reported beginning of the VLCD, total daily insulin dose, and adverse events. We obtained confirmatory data from diabetes care providers and medical records.

RESULTS: Of 316 respondents, 131 (42%) were parents of children with T1DM, and 57% were of female sex. Suggestive evidence of T1DM (based on a 3-tier scoring system in which researchers took into consideration age and weight at diagnosis, pancreatic autoimmunity, insulin requirement, and clinical presentation) was obtained for 273 (86%) respondents. The mean age at diagnosis was 16 ± 14 years, the duration of diabetes was 11 ± 13 years, and the time following a VLCD was 2.2 ± 3.9 years. Participants had a mean daily carbohydrate intake of 36 ± 15 g. Reported mean HbA1c was 5.67% ± 0.66%. Only 7 (2%) respondents reported diabetes-related hospitalizations in the past year, including 4 (1%) for ketoacidosis and 2 (1%) for hypoglycemia.

CONCLUSIONS: Exceptional glycemic control of T1DM with low rates of adverse events was reported by a community of children and adults who consume a VLCD. The generalizability of these findings requires further studies, including high-quality randomized controlled trials.”

Source: Management of Type 1 Diabetes With a Very Low–Carbohydrate Diet | Articles | Pediatrics

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From 2012: Largest Healthcare Fraud Settlement in History Involves Diabetes Drug Avandia

Your friendly neighborhood drug supplier

Your friendly neighborhood drug supplier

“Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today. The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company. GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA). Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600. The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors. GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court. GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states. The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.”

Source: GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data | OPA | Department of Justice

Regarding Avandia:

“The United States alleges that, between 2001 and 2007, GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA that are meant to allow the FDA to determine if a drug continues to be safe for its approved indications and to spot drug safety trends. The missing information included data regarding certain post-marketing studies, as well as data regarding two studies undertaken in response to European regulators’ concerns about the cardiovascular safety of Avandia. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of (1) congestive heart failure, and (2) myocardial infarction (heart attack). GSK has agreed to plead guilty to failing to report data to the FDA and has agreed to pay a criminal fine in the amount of $242,612,800 for its unlawful conduct concerning Avandia.”

And…

“In its civil settlement agreement, the United States alleges that GSK promoted Avandia to physicians and other health care providers with false and misleading representations about Avandia’s safety profile, causing false claims to be submitted to federal health care programs. Specifically, the United States alleges that GSK stated that Avandia had a positive cholesterol profile despite having no well-controlled studies to support that message. The United States also alleges that the company sponsored programs suggesting cardiovascular benefits from Avandia therapy despite warnings on the FDA-approved label regarding cardiovascular risks. GSK has agreed to pay $657 million relating to false claims arising from misrepresentations about Avandia. The federal share of this settlement is $508 million and the state share is $149 million.”

Does this help you understand why I favor diet modification over drug therapy for type 2 diabetes?

Steve Parker, M.D.

low-carb mediterranean diet

Front cover of book

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Are Particular T2 Diabetes Drugs Better Than Others?

From MPT:

“The number of type 2 diabetes drugs that have a proven cardiovascular benefit jumped from one to three this year, highlighting the changing landscape for diabetes treatments.”

Source: Year in Review: Type 2 Diabetes | Medpage Today

The article notes that liraglutide (Victoza), a GLP-1 analogue, was associated with a 13% relative risk reduction in a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.

Semaglutide, an experimental GLP-1 analogue, also has evidence for cardiovascular death prevention.

Another diabetes drug, Jardiance or empagliflozin, also has evidence for cardiovascular death prevention. Jardiance is an SGLT2 inhibitor.

Read the full MPT article for more details. I find the cost of these drugs to be an interesting yet little discussed detail.

Let’s assume these drugs actually reduce cardiovascular disease risk in T2 diabetics. What if they increase death and disease rates from cancer and infection? You don’t hear much about that, do you?

We still don’t know much about the long-term adverse effects of most of our diabetes drugs. That’s one reason I tend to favor diet modification as a primary diabetes treatment.

Steve  Parker, M.D.

low-carb mediterranean diet

Front cover of book

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New Insulin Delivery Recommendations 

Going in at a 45 degree angle with a 6 mm needle

Going in at a 45 degree angle with a 6 mm needle

“Many primary care professionals manage injection or infusion therapies in patients with diabetes. Few published guidelines have been available to help such professionals and their patients manage these therapies. Herein, we present new, practical, and comprehensive recommendations for diabetes injections and infusions. These recommendations were informed by a large international survey of current practice and were written and vetted by 183 diabetes experts from 54 countries at the Forum for Injection Technique and Therapy: Expert Recommendations (FITTER) workshop held in Rome, Italy, in 2015.”

Source: New Insulin Delivery Recommendations – Mayo Clinic Proceedings

Here are some bullet points that most insulin users need to know:

  • Average skin thickness is 2 to 2.5 mm, with 90% of people under 3.25 mm.
  • Use the shortest needles: 6 mm for syringes, 4 mm for pen injectors. The short needles help you avoid injections into muscle. Injection into muscle increases risk of hypoglycemia and wide blood glucose excursions.
  • Acceptable injection sites: abdomen, thighs, buttocks, upper arms (usually on the back of the arm).
  • If an arm site is chosen with a 6 mm needle, inject into a lifted skin fold (otherwise you might hit muscle).
  • When using the 6 mm needle, inject into a lifted skinfold if you are a child or normal-weight adult. Alternatively, insert the needle at a 45 degree angle.
  • The preferred site for regular insulin (soluble human insulin) is the abdomen, for faster absorption.
  • Use needles only once. (Admittedly, many get away with multiple uses without much trouble.)
  • Don’t inject into lipohypertrophy areas. Lipohypertrophy eventually is an issue in half of insulin users. It is a localized area of swelling or lumpiness at the site of prior injections. It’s often easier to feel than to see. Injection into these areas causes erratic absorption of insulin, with potential widely fluctuating and unpredictable blood sugar levels.
  • Rotate injection sites to avoid lipohypertrophy.
  • If using cloudy insulins (e.g., NPH and some pre-mixed insulins), gently roll and tip the vial or pen until the solution is milk white.

Click here to read about…

  • How to roll and tip a vial to make cloudy insulin milk white.
  • Proper needle disposal.
  • Insulin infusion sets for continuous subcutaneous insulin injection via pumps.

Steve Parker, M.D.

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