There’s some good news for type 2 diabetes patients. Firstly it was the Gastric Bypass Surgery considered to improve insulin reaction. And now, the new drug Tradjenta is used in combination with diet and exercise to help improve blood glucose levels amongst adults in treating type 2 diabetes. It is, however, not helpful in treating type 1 diabetes.

The US Food and Drug Administration (FDA) has approved the use of Tradjenta (linagliptin) tablets for the cure of type 2 diabetes. Tradjenta is marketed by Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, Connecticut) and Eli Lilly Co (Indianapolis, Indiana).

According to the FDA, Tradjenta is proven to be safe and helpful in type 2 diabetes patients in eight double-blind, placebo-led studies amongst 3,800 patients. These studies indicate that patients treated with Tradjenta had improved blood glucose control compared with placebo. Clinically noteworthy improvements were seen in hemoglobin A1c (A1C). HbA1c is a good estimation of how well blood sugar levels are managed.

Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research (1) asserts that the approval offers another alternative for the millions of Americans with type 2 diabetes, and is effective when used alone or when added to current treatment regimens.

The FDA said that the drug has been successfully evaluated as a separate treatment and in combination with other type 2 diabetes treatment including metformin, glimepiride and pioglitazone. Tradjenta can be taken on its own or with these other treatments, but not in company of insulin.

Tradjenta works by escalating a patient’s hormone level to stimulate the release of insulin after a meal by blocking the dipeptidyl peptidase-4 (DPP-4) enzyme.

Tradjenta should not be used in Type 1 diabetics or in those who have diabetic ketoacidosis.

Side effects

The most common side effects of the drug are upper respiratory infection. And for this reason, Tradjenta will be marketed along with a FDA Patient Package Insert specifying the drug’s benefits and also its risks.

About diabetes

Diabetes is a chronic disorder marked by high levels of glucose in the blood. Glucose is the key form of sugar in the blood, and insulin is hormones that control the amount of glucose in the blood. In diabetes, the body either cannot accurately make insulin or it cannot react to insulin. High blood glucose levels can cause many health problems and increase the threat for serious conditions including heart disease, blindness, and kidney damage.

There are two types of diabetes:

Type 1 diabetes (also called insulin-dependent diabetes) – it usually shows up in childhood and is commonly genetic. It occurs when the immune system damages insulin-producing cells in the pancreas. Patients are treated with insulin to maintain blood glucose levels within normal limits.

Type 2 diabetes (also called non-insulin-dependent diabetes) – it is the most common form of diabetes. Patients with type 2 diabetes cannot make insulin well or are not able to respond normally to insulin.

The major risk factors of type 2 diabetes include being overweight, sedentary lifestyle, and consumption of large amounts of sweet foods and junk food.

Type 2 diabetes is unquestionably the most common type of illness. Of the 25.8 million diabetics in the United States, nearly 90 percent to 95 percent have type 2 diabetes.

Sources:

Sources:
FDA’s Center for Drug Evaluation and Research

Concerns about Actos

You may be considering pioglitazone or Actos to help treat your diabetes.  But you absolutely need to know that Actos has some very serious side effects and that it’s not entirely clear how well it works.

Pioglitazone, or Actos, is a very popular treatment for Type 2 Diabetes, with prescriptions counting for about 20-25% of total.  It works on peroxisome proliferator activated receptor-gamma receptors to improve sensitivity to insulin in various parts of the body.

The good thing is that Actos does have some benefits.  It seems to lower blood pressure, and seems to have a positive effect on certain important markers of health, like urine composition and levels of lipids in the blood.

And some studies like PROactive have shown that it has significant benefits in lowering risk of mortality from certain aspects of diabetes.

Concerns

First, the way that PROactive measured its outcomes was not properly done and changed in the middle of the study, almost certainly to make the medication come off as being better.  And most of the other studies don’t clearly show health benefits.

Yes, Actos or Pioglitazone does seem to have significant effect on certain physiological factors.  But those measures don’t necessarily translate to improved life-span or reduced risk of events.  And even the PROactive study didn’t have statistically different outcomes for certain serious diabetes related problems.

One analysis of 22 studies argued that 21 of them showed only improvement in surrogate measures.  That means that the medication was shown to have some sort of physical effect but not necessarily have health benefits.

Heart Failure

Worse.  Pioglitazone might significantly increase the risk of heart failure.  In one study, rate of heart failure went up from 2% to 4%, and in another from 8% to 11%.  This is despite having some effects that are good for the heart, like reducing thickness of certain arteries.

Actos also increases risk of bone fracture, and, like a related medication that was withdrawn from the market, may have significant liver toxicity.

Thoughts

Because of these factors, and the lack of definitive and convincing long-term studies focused on measuring health end-points, Pioglitazone’s cost-benefit analysis is not clear.  Its use over other options for Diabetes management should be very carefully considered.

Thanks for reading!

The Diabetes-Reversing Breakthrough

The Diabetes Miracle Breakthrough

Ultimate Diabetic Cookbook