Comparison of the effect of Metformin and Empagliflozin in treatment of prediabetic patients
Design
Clinical trial, Parallel group, Randomised trial, Single blind, in 100 patients
Settings and conduct
Study will start in Shahid Beheshti Hospital in Kashan. After the inclusion and exclusion criteria,the patients were randomly divided into two groups of 50 people,one group being treated with metformin 1000 mg daily and the other group being treated with Empagliflozin tablets 10 mg daily. Before the intervention, the patient's information is entered in the form of a questionnaire and after three months of taking the drug, all these factors are measured again in the referral and the results obtained with the data related to that person in three months It is previously compared and the effectiveness of the drug is estimated. Finally, the data are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Prediabetic patient
Age between 30-80 years old
BMI>25
Exclusion criteria:
Treatment with hormones or drugs that interference glucose metabolism
GFR< 45
Neurogenic bladder disorder
Pregnant or breast feeding mothers
Allergy to Empagliflozin or Metformin
Intervention groups
Empagliflozin tablet 10 mg daily
Main outcome variables
Blood pressure; Blood glucose; Blood lipid; Body mass index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210926052602N1
Registration date:2021-11-11, 1400/08/20
Registration timing:registered_while_recruiting
Last update:2021-11-11, 1400/08/20
Update count:0
Registration date
2021-11-11, 1400/08/20
Registrant information
Name
Sara Hasibi Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2284 5293
Email address
s.hasibi68@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Metformin and Empagliflozin in treatment of prediabetic patients.
Public title
Comparison of the effect of Metformin and Empagliflozin in treatment of prediabetic patients.
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Prediabetic patient
Age between 30-80 years old
BMI>25
Exclusion criteria:
Treatment with hormones or drugs that interference glucose metabolism
GFR< 45
Neurogenic bladder disorder
Pregnant or breast feeding mothers
Allergy to Empagliflozin or Metformin
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided (using the quadruple block method and through the website https://www.sealedenvelope.com/ to prepare a randomization list) into two groups of 50 people and a group treated with metformin 1000 mg daily and the other group are treated with empagliflozin 10 mg daily.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind study in which participants are unaware of the type of medication they receive. In order to perform blinding, the manufacturer was asked to prepare metformin and empagliflozin in exactly the same way (same color, same size, same packaging).
The lead researcher and the physician are aware of the type of medication the patient is taking, but the person responsible for evaluating the statistical data will be unaware of this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Intervention group 1: In this group, which includes 50 participants, empagliflozin tablets made by Actoverco Pharmaceutical Company are given 10 mg in a daily dose for three months.
Category
Treatment - Drugs
2
Description
Intervention group 2: In this group, which includes 50 participants, metformin tablets made by Abidi Pharmaceutical Company are given 1000 mg in a daily dose for three months.