Determination of the efficacy of linagliptin on insulin dose in type 2 diabetic patients with severe renal insufficiency
Design
A clinical trial without a control group, with parallel groups, without blinding, was randomized and 96 patients with a size of 4 blocks would be randomly assigned to two groups.
Settings and conduct
The study population was patients aged 18-80 years referred to the Babol Spiritual Educational and Medical Center. Patients are randomly divided into two groups using a random number table by computer.
Intervention group1: Treatment with a long-acting insulin regimen (based on the patient's body weight / weight and sugar) will be given subcutaneously.
Intervention group2: Treatment with long-acting insulin regimen (based on kg / body weight and patient sugar) will be used subcutaneously plus 5 mg of linaglyptin tablets (Abu Reihan Company) once a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Type 2 diabetes, Severe renal failure (GFR below 30), Age 80 - 18 years, HbA1C between 7 and 10
Exclusion criteria:Inability to follow the patient, Discontinue insulin or linagliptin
Intervention groups
Intervention group1: Treatment with a long-acting insulin regimen (based on the patient's body weight / weight and sugar) will be given subcutaneously.
Intervention group2: Treatment with long-acting insulin regimen (based on kg / body weight and patient sugar) will be used subcutaneously plus 5 mg of linaglyptin tablets (Abu Reihan Company) once a day.
Main outcome variables
Decreased HbA1C and insulin dose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210609051526N1
Registration date:2021-06-14, 1400/03/24
Registration timing:prospective
Last update:2021-06-14, 1400/03/24
Update count:0
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Neda Meftah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3233 8301
Email address
n.meftah@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of linagliptin on insulin dosage in type 2 diabetes patients with sever renal failure (randomized clinical trial)
Public title
Efficiency of linagliptin on insulin dosage in type 2 diabetes patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes
Severe renal failure (GFR below 30)
Age 80 - 18 years
HbA1C between 7 and 10
Exclusion criteria:
Inability to follow the patient
Discontinue insulin or linagliptin
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of 48 using 4 blocks and a ratio of 1: 1. The free website www.randomization.com will be used to generate the allocation sequence. The resulting sequence will be written on separate sheets and placed in sealed envelopes and will be provided to the lead researcher for study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.MUBABOL.REC.1400.106
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Change insulin dose
Timepoint
At the beginning of the study and at the end of weeks 12 and 24
Method of measurement
Fasting blood sugar test, HBA1c test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Treatment with a long-acting insulin regimen (based on the patient's body weight / weight and sugar) will be given subcutaneously.
Category
Treatment - Drugs
2
Description
Intervention group2:Treatment with long-acting insulin regimen (based on kg / body weight and patient sugar) will be used subcutaneously plus 5 mg of linaglyptin tablets (Abu Reihan Company) once a day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Neda Meftah
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
n.meftah@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?