Comparison of efficacy of short-acting insulin (Regular) manufactured by Ronak Daru (Ronulin ®) with manufactured by Exir (Lansulin®) in reducing blood sugar after meals in patients with type 2 diabete
The main goal of study is Comparison of efficacy of short-acting insulin (Regular) manufactured by Ronak Daru (Ronulin ®) with manufactured by Exir (Lansulin®) in reducing blood sugar after meals in patients with type 2 diabetes. Study is randomized, single centre, cross-over, and not blind that was done on 40 patients with type 2 diabetes that treated with insulin with or without oral agent. This patients treat with less than 1.4 U/kg/d well, is more than 18 years old, isn’t obese, and don’t have any complication. We take Informed consent from them. Duration of study is 3 months for any group (first 3 months for Ronalin or Lansulin and then inverse).Dosage of regular insulin or NPH insulin is as before. NPH insulin of two groups is Lansulin. Patients is visited by physician during the study every 2 weeks and is checked for FBS, 2 hr postprandial, and acute complications such as hypoglycemia or hyperglycemia. The primary outcome is HbA1c after survey. The secondary outcome is weight and insulin dosage difference and acute complications( hypoglycemia and hyperglycemia).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013040812938N1
Registration date:2013-04-24, 1392/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-24, 1392/02/04
Registrant information
Name
Zahra Kourorian
Name of organization / entity
Ronak Daru Company of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9441
Email address
zkourorian@irimc.org
Recruitment status
Recruitment complete
Funding source
Ronak Daru Company of pharmacy
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of short-acting insulin (Regular) manufactured by Ronak Daru (Ronulin ®) with manufactured by Exir (Lansulin®) in reducing blood sugar after meals in patients with type 2 diabete
Public title
Insulin efficacy in diabetes management
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria: 1-diabetic patients type 2 treated with insulin with or without oral drug. 2-100mg/dl< FBS <250mg/dl. 3-7< HbA1c< 9. 4-male or female with age > 18 years old*. 5-BMI≤30 kg/m2. *We have enrolled patients with age more than 18 years, according to reference 17, 18, 19, and 20.Age don’t be considered as a confounding factor because study has randomized design.
exclusion criteria: 1- microvascular and macrovascular complications. 2-hypoglycemia(BS<45mg/dl) or hyperglycemia(BS>250mg/dl). 3-pregnancy or Breastfeeding. 4- use of glucocorticoides or any drug that lead hyperglycemia. 5- uncontrolled HTN (BP>180/105). 6-iinsulin allergy. 7-use of more than 1.4 U/kg/d insulin. 8-نرمال Cr>2 mg/dl or LFT>twofold normal range. 9-Patient withdrew from the study.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Molla Sadra Ave, Vanak Sq.
City
Tehran
Postal code
Approval date
2012-10-17, 1391/07/26
Ethics committee reference number
340/22/س
Health conditions studied
1
Description of health condition studied
Diabete
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
mean of HbA1c in the end of study
Timepoint
HbA1c levels before and after of any intervation
Method of measurement
at before and after of intervation by laboratory with HPLC assay
Secondary outcomes
1
Description
hypoglycemia
Timepoint
during study
Method of measurement
Bionime Glucometer
2
Description
weight changes
Timepoint
before and after of intervation
Method of measurement
scale
3
Description
hyperglycemia
Timepoint
during study
Method of measurement
Bionime glucometer
4
Description
insulin dosage
Timepoint
during study
Method of measurement
unit
Intervention groups
1
Description
control: manufactured by Exir (Lansulin®)
Category
Treatment - Drugs
2
Description
Ronak Daru (Ronulin ®)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Chemical Injury Research Center
Full name of responsible person
Dr nahid Khalili
Street address
Baqiyatalla Hospital, Molla Sadra Ave, Vanak Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ronak Daru Company of pharmacy
Full name of responsible person
Dr Zahra Kororian
Street address
Fatemi Ave, Hashtbehesht Str,Ardeshir Str,No 10/3
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ronak Daru Company of pharmacy
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Chemical Injury Research Center
Full name of responsible person
Dr yunes Panahi
Position
Associate of Professor/head of Chemical Injury Research Center
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences, Molla Sadra Ave, Vanak Sq
City
Tehran
Postal code
Phone
+98 21 8821 1524
Fax
Email
yunespanahi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Internal Medicine Department
Full name of responsible person
Dr nahid Khalili
Position
Assistant of Professor
Other areas of specialty/work
Street address
Baqiyatallah University of Medical Sciences,Molla Sadra Ave, Vanak Sq
City
Tehran
Postal code
Phone
+98 21 8126 3988
Fax
+98 21 8126 3989
Email
nkhalili09@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ronak Daru Company of pharmacy
Full name of responsible person
Dr Zahra Kourorian
Position
General Physician/Manager of Clinical trials
Other areas of specialty/work
Street address
Fatemi Ave, Hashtbehesht Str,Ardeshir Str,No 10/3
City
Tehran
Postal code
1414713461
Phone
+98 21 8898 9441
Fax
+98 88989443
Email
zkourorian@razi.tums.ac.irzkourorian@irimc.org
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)