Elderly Diabetes Patients Have Less Hypoglycemia in Januvia Study
Comparison data with sulfonylurea to be presented at the American Diabetes Association 72nd Annual Scientific Sessions that
June 9, 2012 – Senior citizens – those age 65 or older – with type 2 diabetes will cheer the analysis results announced
today by Merck that its drug Januvia (sitagliptin) achieved similar blood sugar reductions as those produced by sulfonylurea but with
“significantly” less low blood sugar (hypoglycemia). Merck says it may suggest fewer falls for seniors.
"The general effects of aging complicate the treatment of diabetes in the elderly; in particular, hypoglycemia is of
greater concern in this population and may lead to dizziness and accidents or falls, which are more likely to be dangerous in the elderly,"
said Barry J. Goldstein, M.D., Ph.D., Vice President and Therapeutic Area Head, Diabetes and Endocrinology, Merck Research Laboratories.
"Therefore, careful consideration of treatment options for older patients is important."
Hypoglycemia can be more of a challenge in elderly patients and recognition of the symptoms of hypoglycemia may be
diminished. Symptoms that may be caused by low blood sugar include: nervousness or anxiety, shakiness, sweating, tiredness, confusion, hunger
Nearly 26 million people in the United States (8.3 percent of the population) have diabetes, and 90 to 95 percent of
diagnosed cases of diabetes are type 2 diabetes. According to the American Diabetes Association, of those with diabetes, 10.9 million people
are age 65 years or older.
Januvia is prescribed, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes
mellitus. The Merck says Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Januvia is a selective, once-daily DPP-4 inhibitor that increases active GLP-1 and GIP hormones, part of a natural body
system called the incretin system to help regulate blood sugar. Januvia inhibits the DPP-4 enzyme over 24 hours. Januvia is the first approved
compound in the DPP-4 inhibitor class of oral treatments. Januvia has been approved in more than 107 countries, and to date, more than 42.5
million prescriptions have been dispensed for the sitagliptin family of products worldwide.
About the post-hoc analysis
This post-hoc analysis pooled data of elderly patients that completed trials through 30 weeks from three double-blind
clinical studies of sitagliptin 100 mg/day (as monotherapy and in combination with metformin) compared to sulfonylureas (in titrated doses;
glipizide or glimepiride).
The analysis compared the effects of Januvia 100 mg once daily or a sulfonylurea (in titrated doses) on change from
baseline in A1C, fasting plasma glucose, body weight and the proportion of patients that experienced one or more episodes of symptomatic
In two studies, patients on diet alone or metformin were randomized to receive Januvia 100 mg/day (as a monotherapy or in
combination with metformin) or the sulfonylurea glipizide (as a monotherapy or in combination with metformin) for 104 weeks, and in the third
study patients were randomized to receive Januvia or the sulfonylurea glimepiride for 30 weeks.
Since the third study was 30 weeks in duration, the analysis focused on results at or close to 30 weeks and included the
373 elderly patients who completed the trials through this time point.
Elderly patients taking Januvia 100 mg/day (n=178; 0.73 percent LS mean A1C reduction from a baseline of 7.5 percent)
achieved similar blood sugar reductions as patients taking a sulfonylurea (n=195; 0.78 LS mean percent A1C reduction from a baseline of 7.5
Of the patients taking a sulfonylurea, 28.2 percent experienced one or more episodes of symptomatic hypoglycemia,
compared to 6.2 percent of patients taking Januvia.
Today’s Merck (NYSE: MRK) (known as MSD outside the U.S. and Canada) is a global healthcare leader working to help the
world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies,
and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
Links to Archived Reports on Diabetes
Should YOU be tested for diabetes?
Anyone 45 years old or older should consider getting tested for diabetes. If you are 45 or older and overweight-see the
BMI chart -getting tested is strongly recommended. If you are younger than 45,
overweight, and have one or more of the
risk factors, you should consider getting tested. Ask your doctor for a fasting
blood glucose test or an oral glucose tolerance test. Your doctor will tell you if you have normal blood glucose, prediabetes, or diabetes.
● Among U.S. residents ages 65 years and older, 10.9 million, or 26.9 percent, had diabetes in 2010.
● Diabetes affects 25.8 million people of all ages - 8.3 percent of the U.S. population
> DIAGNOSED - 18.8 million people
●> UNDIAGNOSED - 7.0 million people
● About 215,000 people younger than 20 years had diabetes—type 1 or type 2—in the United States in 2010.
● About 1.9 million people ages 20 years or older were newly diagnosed with diabetes in 2010 in the United States.
● In 2005–2008, based on fasting glucose or hemoglobin A1C (A1C) levels, 35 percent of U.S. adults ages 20 years or
older had prediabetes - 50 percent of adults ages 65 years or older. Applying this percentage to the entire U.S. population in 2010 yields an
estimated 79 million American adults ages 20 years or older with prediabetes.
● Diabetes is the leading cause of kidney failure, nontraumatic lower-limb amputations, and new cases of blindness
among adults in the United States.
● Diabetes is a major cause of heart disease and stroke.
● Diabetes is the seventh leading cause of death in the United States.