First oral drug for Type 1 diabetes on verge of FDA approval

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Most people with diabetes have Type 2, with an assortment of drugs at their disposal.

But somewhere between 1.5 and 3 million Americans are living with Type 1 diabetes, and their only drug option, insulin, is what keeps them alive.

Now, in a world's first, a new oral drug for this disease could change the way they manage their disease.

As a Type 1 diabetic, Claire Pegg has checked her blood sugar levels many more times than she can count.

"There is so much judgement with every minute of the treatment. You are good or you are bad because your blood sugar is whatever it is," Claire explains.

Hitting the target A1C level, a measurement of blood sugar control, is difficult and often impossible.

"Seventy percent of the people in the US do not achieve target A1Cs," says Satish Garg, MD, an endocrinologist at the Barbara Davis Center for Diabetes at the University of Colorado – Denver.
That means a higher risk of long-term complications like heart, nerve and kidney disease.

Now, a new drug could make reaching that target easier.

"For people with Type 1 diabetes, this may be the biggest breakthrough that they'll see," Garg says.

The drug, called sotagliflozin, blocks the re-absorption of sugar in the kidneys and delays absorption of glucose from the gut.

Patients lose sugar in the urine, which means less in their blood.

Researchers found a two-fold increase in the number of patients who reached the target A1C level while on the drug.

There are other benefits too.

"People lose about 3 to 4 percent of their body weight. In addition, about 10 to 15 percent reduction in insulin dose," Garg explains.

If it's approved, it will be the first oral drug for Type 1 diabetes ever.

While in the study, Claire's A1C level dropped well into that target range. She also lost 20 pounds.

"It's incredible. It's absolutely incredible," she says.

She hopes the FDA thinks so too.

"I will have script in hand and waiting to get my hands on it. I just, I can't wait," Claire admits.

Before insulin was discovered in 1921, Type 1 diabetes was a death sentence. There have been many advances in technology that have drastically improved the lives of people with the disease, but new drugs to treat it have been nonexistent.

It's important to note that this drug will not replace insulin.

The FDA's decision is expected by the end of the month

MEDICAL BREAKTHROUGHS
RESEARCH SUMMARY

TOPIC: FIRST EVER ORAL DRUG FOR TYPE 1 DIABETES
REPORT: MB #4552

BACKGROUND: About five percent of people in the world have type 1 diabetes. It is mainly contracted by adults, but it used to be called juvenile diabetes. The body does not produce insulin which is used to help move blood sugar throughout the bloodstream. Symptoms of type 1 diabetes are frequent urination, extreme fatigue,
blurry vision, weight loss and feeling thirsty or hungry. African Americans, Latinos and those who are overweight are most at risk. It is very easy to mistake it for type 2 diabetes, but the treatment is very different. (Source: http://www.diabetes.org/diabetes-basics/type-1/?loc=db-slabnav )

TREATMENTS: There are a series of tests that can be given to patients with possible diabetes. A glycated hemoglobin test can help register your blood sugar for the past two three months. If the levels come back as 6.5 or higher twice then it is diabetes. The other two tests are fasting blood sugar test and a random blood sugar test. The fasting test occurs after overnight fasting and if your blood sugar levels are under 100 then it is normal. If they are between 100 and 126 then it is prediabetes, and if it is above 126 then it is diabetes. If your blood sugar is 200 mg/dL (milligrams per deciliter) when you are given a random blood sugar test, that could suggest diabetes. Treatment for type 1 diabetes is insulin, eating healthy, exercising, and carbohydrate, fat and protein counting, and blood sugar monitoring. The insulin can be given through injections or a pump. (Source: https://www.mayoclinic.org/diseases-conditions/type-1-diabetes/diagnosis-treatment/drc-20353017)

NEW TECHNOLOGY: Sotagliflozin, or Zynquista, is an inhibitor that uses two proteins. One of the proteins absorbs the glucose in the gastrointestinal tract while the other helps the kidneys reabsorb the glucose. There have been three clinical trials already for the drug with 3,000 participants. The FDA has recently voted to find out if the benefits outweigh the risks. The vote is to take place in March. If approved, it would be the first oral antidiabetic drug to be approved in the US. The European Medicines agency will also be voting on the matter in the first half of this year. (Source: http://www.news.sanofi.us/2019-01-17-FDA-advisory-committee-votes-on-Zynquista-TM-sotagliflozin-as-treatment-for-adults-with-type-1-diabetes