Januvia (Sitagliptin) Approved For Individuals With Diabetes Type 2 With Kidney Impairment, United kingdom


The Medications and Healthcare items Regulating Agency (MHRA) has approved Januvia (sitagliptin) within the United kingdom to be used in people struggling with moderate to severe kidney impairment. Consequently, another treatment is going to be readily available for people with sub-optimum kidney function, who represent as much as 1 / 3 of individuals with diabetes.

Your application took it’s origin from two 54 days studies analyzing the success and safety of sitagliptin versus glipizide in patients with moderate to severe kidney impairment and kind 2 diabetes (T2D), in addition to patients with T2d and finish-stage kidney disease (ESRD) on dialysis.

Within the first study, participants with moderate to severe kidney impairment were designated to get either 25 or 50 mg once daily of sitagliptin or 2.five to twenty mg once-a-day’s glipizide. Is a result of the research says after 54 days, sitagliptin created an average decrease in HbA1c of -.76% in comparison with -.64% with glipizide. Participants within the glipizide group had an incidence of hypoglycemia of 17% in comparison to simply 6.2% within the sitagliptin group, a statistically factor.

Within the second study, patients with ESRD on dialysis were designated to get either 25 mg once daily of sitagliptin for 54 days or glipizide. The beginning dose with glipizide was 2.5 mg q.d. and titrated up or lower to some potential maximum dose of 10 mg b.i.d (20 mg/day). Is a result of the research demonstrated that sitagliptin provides scientifically significant reductions from baseline in HbA1c by -.72% in comparison with -.87% with glipizide.

The scientists discovered that fasting plasma glucose (FPG) was similar to individuals seen with glipizide. Additionally, sitagliptin was well tolerated and also the incidence of symptomatic hypoglycemia was less than glipizide. However, the scientists found no considerable improvement in the incidence of hypoglycemia between your sitagliptin group (6.3%) and also the glipizide group (10.8%).

Dr. Donal O’Donoghue, Consultant Nephrologist and lead investigator for that Greater Manchester CLAHRC project CKD theme in the College of Manchester, described:


“If people with type 2 diabetes have impaired renal function, their kidneys do not filter the blood as efficiently as people with normal kidney function. These patients can pose a management problem because some diabetes treatments are either unsuitable for them, or the dosage must be adjusted dependent upon renal function.

The sitagliptin license extension means that patients with advanced renal impairment, stages 4 and 5 CKD can now be controlled with a simple dosage adjustment. For patients with mild renal impairment no dose adjustment is required, which is a real practical benefit.”


Professor John Wilding, Head of the Department of Obesity and Endocrinology at the University of Liverpool, said:

“One of the main complications of diabetes is kidney disease, or diabetic nephropathy, and this unfortunately develops in up to one third of all people with diabetes. Once the kidneys are damaged due to high levels of blood glucose, early stage kidney disease will follow.

Control of blood pressure and blood glucose can help reduce the risk of kidney disease in people with diabetes, but treatment choices for glucose-lowering treatments are limited because some drugs cannot be used in people with kidney disease, or may increase the risk of hypoglycemia (low blood sugar).

Physicians around the world have been prescribing sitagliptin at 25 mg and 50 mg in this large patient population for a number of years, so it is pleasing that in the UK we now have the option for dosage adjustment to improve glycaemic control, in renally compromised patients with a low risk of hypoglycemia.”


Diabetes type 2 is easily the most prevalent of these two primary kinds of diabetes (type 1 and kind 2) and accounts for 90% of individuals with diabetes. Within the United kingdom, 2.9 million people are identified using the condition, as well as an believed 850,000 people have diabetes type 2 by are undiagnosed, so it is believed that within the United kingdom, 2.61 million people are influenced by the problem.

Roughly 1 / 3 of people with type 1 or diabetes type 2 develop diabetic kidney disease – probably the most prevalent reason for kidney failure within the United kingdom. Signs and symptoms of diabetic kidney disease include:

  • Swelling of the limbs
  • Fatigue
  • Vomiting
  • Nausea

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