Evaluation the effect of Linagliptin and Empagliflozin combination on glycosylated hemoglobin and fasting blood sugar control in patients with type 2 diabetes
determining the effect of the combination of Linagliptin and Empagliflozin on the control of glycosylated hemoglobin and fasting blood sugar in patients with type 2 diabetes
Design
Semi-experimental clinical trial, without control group, without blinding, without randomization, phase 2, on 55 patients.
Settings and conduct
Diabetic patients attended to the endocrinology clinic of Amir al-Mominin Hospital and Imam Reza Clinic who did not respond properly to other oral treatments.They also received oral medicine in a suitable period of time, but the appropriate response in reducing hba1c was not satisfactory.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who are diagnosed with type 2 diabetes based on ADA diagnostic criteria and have medical treatment indications
Patients who have not reached the treatment goals despite receiving previous medications (HbA1c) more than 7 and FBS (more than 130).
exclusion criteria:
Type 1 diabetes
pregnancy
Diabetic ketoacidosis (current and previous history)
Pancreatitis (current and previous history)
Diabetic foot ulcer (current and previous history)
GFR less than 30
BMI less than 18.5
The occurrence of severe drug side effects for the patient
Lack of consent to participate in the study
untreated Urinary Tract Infection {UTI}
Intervention groups
Patients will receive the combination of linagliptin and empagliflozin
Main outcome variables
HBA1C; FBS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221016056201N1
Registration date:2023-02-08, 1401/11/19
Registration timing:prospective
Last update:2023-02-08, 1401/11/19
Update count:0
Registration date
2023-02-08, 1401/11/19
Registrant information
Name
Mohammad Davari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3477 8386
Email address
buccynator@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Linagliptin and Empagliflozin combination on glycosylated hemoglobin and fasting blood sugar control in patients with type 2 diabetes
Public title
Effect of Linagliptin and Empagliflozine on diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who have been diagnosed with type 2 diabetes mellitus based on the ADA diagnostic criteria and indicated for medical therapy
patients who have not reached to treatment goals despite receiving previous medications
Exclusion criteria:
type 1 diabetes
pregnancy
diabetic ketoacidosis (present and previous)
pancreatitis (present and previous)
diabetic foot ulcer (present and previous)
GFR less than 30
BMI less than 18.5
severe adverse drug reactions
lack of consent to participate in the study
untreated urinary tract infection
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of Arak University of Medical Sciences
Street address
Arak Univercity of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-04-02, 1401/01/13
Ethics committee reference number
IR.ARAKMU.REC.1401.004
Health conditions studied
1
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
fasting blood sugar
Timepoint
beginning of the study, 3 months later
Method of measurement
blood sample
Secondary outcomes
1
Description
glycosylated hemoglobin
Timepoint
beginning of the study, 3 months later
Method of measurement
blood sample
Intervention groups
1
Description
Intervention group: type 2 diabetic patients resistant to other oral anti-diabetic treatments (metformin, glybenclamide and acarbose) whose FBS and HbA1C are not within the therapeutic range despite regular use of these drugs. These patients receive the combination of empagliflozin and linagliptin daily for 3 months, then their FBS and HbA1C will be measured again and compared with their baseline FBS and HbA1C on the first day of the study. Patients will be taught to take one empagliflozin and linagliptin combination tablet daily during these three months and to adhere to this method of use.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al Momenin hospital
Full name of responsible person
Mohammad Davari
Street address
Sardasht, Amir-al-momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 2221
Email
buccynator@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehdi Salehi
Street address
Sardasht,Amir-al-momenin Hospitl
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Davari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sardasht,Amir-al-momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 2221
Email
buccynator@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Davari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sardasht,Amir-al-momenin Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 2221
Email
buccynator@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Davari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Sardasht, Amir-al momenin hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 2221
Email
buccynator@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available