Bioequivalence and Bioavailability Forum • Gender effect on metformin and sitagliptin

khageswara Rao
☆

India,
2022-03-01 08:26
(1175 d 20:37 ago)

Posting: # 22816
Views: 2,924

Gender effect on metformin and sitagliptin [Regulatives / Guidelines]

Dear All,

As per updated guidelines

If a drug product is intended for use in both sexes, the applicant should include similar proportions of males and females in the study or provide a justification supporting the use of a single-sex population.

for metformin and Sitagliptin we have enrolled only male subjects so please provide the justification on the same of gender effect. with references.

Your quick response will much helpful

Thanks in advance.

dshah
★★

India,
2022-03-01 14:01
(1175 d 15:01 ago)

@ khageswara Rao
Posting: # 22818
Views: 2,530

Gender effect on metformin and sitagliptin

Post reply

Dear Khageswara Rao!
As per label for metformin: Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analyzed according to gender (males = 19, females = 16). Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycemic effect of metformin hydrochloride tablets, USP was comparable in males and females.

For Sitagliptin: Based on a population pharmacokinetic analysis or a composite analysis of available pharmacokinetic data, BMI, gender, and race do not have a clinically meaningful effect on the pharmacokinetics of sitagliptin. When the effects of age on renal function are taken into account, age alone did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis. Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Kindly find the screenshot for same:
[image]

Thus, gender effect is not anticipated and inclusion of only male subject should not have clinical significance on outcome of study.
Regards,
Divyen Shah

khageswara Rao ☆ India, 2022-03-03 06:54 (1173 d 22:08 ago) @ dshah Posting: # 22820 Views: 2,373	Gender effect on metformin and sitagliptin Post reply
	Tq so much Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]