type 2 diabetes drugs

Type 2 Diabetes: Medical Groups Disagree on What Your A1c Goals Should Be

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A1c goals for type 2 diabetes

The American College of Physicians (ACP) has written a guidance statement for providers to use when selecting targets for pharmacologic treatment of type 2 diabetes.

In other words, they share how aggressive clinicians should be when it comes to using medications to treat type 2 diabetes.

The American College of Physicians Guidance Statement

1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of benefits and harms of pharmacotherapy, patients’ preferences, patients’ general health and life expectancy, treatment burden, and costs of care.

2: Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes.

3: Clinicians should consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%.

4: Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population.

Diabetes Medical Associations Disagree

Medical associations whose focus is diabetes do not agree with the ACP’s guidance statement.

The president of the ACP, Dr. Jack Ende explained in a statement that “ACP’s analysis of the evidence behind existing guidelines found that treatment with drugs to targets of 7 percent or less compared to targets of about 8 percent did not reduce deaths or macrovascular complications such as heart attack or stroke but did result in substantial harms,”

“The evidence shows that for most people with type 2 diabetes, achieving an A1C between 7 percent and 8 percent will best balance long-term benefits with harms such as low blood sugar, medication burden, and costs,” he added.

Do These Recommendations Prioritize Individualized Care?

It’s reasonable to wonder that if taking medications is not a burden and costs are not an issue and low blood sugar risk is appropriately managed, is an A1c between 7 and 8 percent less desirable than one closer to non-diabetic levels? Type 2 diabetes is a serious disease and a 7% A1c would lead to its diagnosis, meaning that an A1c between 7 and 8 is not ideal for good health.

Yet, the reality is that these burdens do exist for a great many patients. The ACP seems to make the case that when burdens increase and patients do not reap additional health benefits in return, the extra medication intervention is not worthwhile but actually detrimental.

It makes sense to seek guidance from statistics. The problem is when these recommendations trump individualized care. It may make sense for one type 2 patient to keep a higher A1c level based on their unique circumstances but it would be an irresponsible measure for a provider not to share the risks of the higher A1c with any patient and leave them inadequately treated.

The ACP is not against a more ideal end result, however.

“Although ACP’s guidance statement focuses on drug therapy to control blood sugar, a lower treatment target is appropriate if it can be achieved with diet and lifestyle modifications such as exercise, dietary changes, and weight loss,” said Dr. Ende. Perhaps this signals a change in focus from aggressive drug therapy to lifestyle interventions or perhaps more of an an emphasis on a healthier balance between the two.

The American Diabetes Association’s chief medical officer Dr. William Cefalu told NPR News that they disagree with the ACP’s guidelines and stand by their own. He said that new drugs are effective in managing blood sugar and carry less risk for low blood sugar and some of them help lower body weight and improve cardiovascular risk factors–a win/win for patients who need to address all three common issues.

Former president of the American Association of Endocrinologists, Dr. George Grunberger told NPR that “The moment your glucose goes above normal, it’s incurring damage to the back of the eye, to kidneys and to nerves, especially in your feet,” and that he worries these guidelines will effectively tell physicians not to worry too much about their patients elevated A1c levels.

The Endocrine Society released a statement as well, sharing their strong disagreement with the ACP’s statement. They pointed out in a press release that the ACP’s “recommendations do not consider the positive legacy effects of intensive blood glucose control confirmed in multiple clinical trials, particularly for those newly diagnosed with type 2 diabetes, and, therefore, are not reflective of the long-term benefits of lower A1C targets.”

The recommendations might prove costly if physicians do not treat each individual on a case-by-case basis. Physicians and patients need to have very candid talks about what is desired because not all patients want or are capable of the same things.

So Who is Right?

The ACP has a point about how few benefits are often seen at various points of treatment which barely outweigh burdens incurred by type 2 diabetes patients who are treated aggressively with medications.

However, other medical associations who recommend getting A1c levels lower are also accurate in recommending for lower targets. Blood sugar levels above normal do indeed cause damage, even if only slightly elevated. Patients have a right to be aware of that fact and to get help from their provider in achieving normal blood sugar levels, if possible.

Should providers encourage normal blood sugars or should they follow their patient’s lead? The ACP’s stance suggests the patient needs to advocate for the best blood sugar outcomes they can get. Will this guidance statement lead patients to leave providers who want them to settle at higher A1c targets? Finding new providers is often more than an inconvenience. Will this stance ultimately help or hurt patients?

As studies indicate, the future points to more emphasis on lifestyle habits as well as better medications. It’s also likely that continuous glucose monitoring devices, known as CGM are going to be used more in type 2 diabetes and become powerful aids. An individual with type 2 diabetes using a CGM will be able to find out exactly what certain foods, stress, and exercise does to their blood sugar levels and be motivated to act accordingly.

Perhaps a good question to ask is what motivations do people with type 2 diabetes have to rely more on lifestyle interventions versus aggressive medication protocols?

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Exenatide via Osmotic Mini-Pump Improved A1c and Weight

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ITCA 650 by Intarcia

 

ITCA 650 is exenatide in an osmotic mini-pump, a type 2 diabetes medication. It continually provides subcutaneous medication for 3 to 6 months.

Currently, exenatide is available as the brand name Byetta which is a liquid injection and also an extended release formulation marketed as Bydureon which comes in a powder that is mixed with liquid and then injected.

Researchers tested out ITCA 650 in two dose amounts and compared it to a placebo in patients with uncontrolled type 2 diabetes.

Over 39 weeks, this phase 3, double-blind, placebo-controlled trial randomized 460 patients between the ages of 18 and 80 who had an A1c level between 7.5 and 10 % (58-86 mmol/mol). So a third of participants took a placebo, another third ITCA 650 40 μg per day and another third took ITCA 650 60 μg per day.

The researchers looked for any A1c changes after those 39 weeks.

Does Exenatide Help Lower A1c Levels?

Taking ITCA 650 showed to lower A1c levels when compared to the placebo dose. The researchers wrote in their abstract that “In a prespecified analysis, greater HbA1creductions occurred in patients not receiving sulfonylureas (SUs) vs. those receiving SUs (−1.7% vs. −1.2% [−18.6 and −13.1 mmol/mol].”

They add that on week 39 37% of those taking ITCA 650 40 μg per day had an A1c below 7% (53 mmol/mol)–44% of those taking 60 μg per day lowered their A1c under 7% (53 mmol/mol) and only 9% of the placebo group lowered their A1c under 7% (53 mmol/mol).

ITCA 650 users also showed more weight loss than those on the placebo. The higher the dose of ITCA 650, the more weight lost.

As far as the most common adverse event, nausea was observed but also showed to go away with time. Of those taking ITCA, 7.2% stopped taking the medication because of gastrointestinal adverse effects while only 1.3% of patients stopped taking the placebo due to the same.

They concluded that “ITCA 650 significantly reduced HbA1c and weight compared with placebo and was well tolerated in patients with uncontrolled type 2 diabetes on oral antidiabetes medications.”

Wait, How Does an Osmotic Mini-Pump Work?

Intarcia Therapeutics is the company behind the osmotic mini-pump for ITCA 650. Their website states that their Medici Drug Delivery System is made so a trained healthcare provider can insert it in a patient during a regular in-office visit.

First it is placed under the skin and then “water from the extracellular fluid enters the pump device at one end – by diffusing through a semi-permeable membrane directly into an osmotic engine – that expands to drive a piston at a controlled rate.” This action lets the drug inside the pump release continuously at the other end of the pump. These osmotic mini-pumps are created to carry “an appropriate volume of drug over different dosing intervals,” states the company’s website.

The company is currently awaiting FDA approval.

Regarding the insertion of this device, the study authors state that the adverse effects “associated with procedures to place and remove ITCA 650 were mild and transient”.