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Practical Focus at ADA/EASD Consensus algorithm in type2 Diabetics: Timely Glargine insulin initiation and titration (Morning/Evening) and the evaluation of HbA1C

Protocol summary

Summary
The goal of this study was two focus at ADA/EASD consensus algorithm in type 2 diabetics : timely glargine insulin initiation and titration (morning / evening ) the study is a single blind clinical trial , randomized multi center , prospective study . the total number of subjects recruited in the study will be at least 725 whom were recruited from 73 center . Male or Female ≥ 18 years old ; More than 1 year after diagnosis of type 2 diabetes; A baseline HbA1c >7% but <10% obtained within 2 months before inclusion; Insulin naïve who is taking metformin / metformin + SU/ metformin + pioglitazone ± SU OR Insulinized who is receiving a single daily or twice daily injection of maximum tolerated NPH insulin dose with metformin ± SU ± pioglitazone, and for whom FPG is > 130 mg/dL . Exclusion Criteria: Pregnant or breast feeding women ; Patients already treated with insulin other than NPH insulin; Patients treated with oral anti diabetic drugs other than metformin, SU or Pioglitazone; Patients not willing, or not able, to perform and record self-monitoring blood glucose; Patients not willing, or not able, to self-titrated insulin glargine under physician’s guidance; Patients who are not suitable for close follow up; Patients with any serious underlying illness, including hepatic failure (AST> 3 ULN), renal failure (creatinine > 1.5 mg/dl in males and > 1.4 mg/dl in females); Hospitalized patients and psychiatric disease ; Patients with history of alcohol or drug abuse ;Patients who used corticosteroids ; Patient who are involved in other clinical trials ; Known hypersensitivity to glargine insulin . a central data processing and a statistical analysis plan (SAP) will be performed an behalf of Sanofi , and also data was analyzed by usage of SPSS18 , and other statistical methods such as T-Test , chi-squre , paired T-test , Anova Regression .The primary and secondary outcomes of the study was : the percentage of patients achieving HbA1C < %7 at the end of 3 & 6 months period, Change of insulin doses and Hypoglycemia. This study was done in 2 groups of 365 patients . that the protocol was timely initiation and titration of Glorgine insulin (Morning / Evening )

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111283384N7
Registration date: 2011-12-04, 1390/09/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-04, 1390/09/13
Registrant information
Name
Ameneh Ebrahim Valoojerdi
Name of organization / entity
Endocrine research center
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
info@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Sanofi Co.
Expected recruitment start date
2011-07-27, 1390/05/05
Expected recruitment end date
2012-07-27, 1391/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Practical Focus at ADA/EASD Consensus algorithm in type2 Diabetics: Timely Glargine insulin initiation and titration (Morning/Evening) and the evaluation of HbA1C
Public title
Practical Focus at ADA/EASD Consensus algorithm in type2 Diabetics: Timely Glargine insulin initiation and titration (Morning/Evening)
Purpose
Treatment
Inclusion/Exclusion criteria
Male or Female ≥ 18 years old ; A baseline HbA1c >7% but <10% obtained within 2 months before inclusion; Insulin naïve who is taking metformin / metformin + SU/ metformin + pioglitazone ± SU OR Insulinized who is receiving a single daily or twice daily injection of maximum tolerated NPH insulin dose with metformin ± SU ± pioglitazone, and for whom FPG is > 130 mg/dL . Exclusion Criteria: Pregnant or breast feeding women ; Patients already treated with insulin other than NPH insulin; Patients treated with oral anti diabetic drugs other than metformin, SU or Pioglitazone; Patients not willing, or not able, to perform and record self-monitoring blood glucose; Patients not willing, or not able, to self-titrated insulin glargine under physician’s guidance; Patients who are not suitable for close follow up; Patients with any serious underlying illness, including hepatic failure (AST> 3 ULN), renal failure (creatinine > 1.5 mg/dl in males and > 1.4 mg/dl in females); Hospitalized patients and psychiatric disease ; Patients with history of alcohol or drug abuse ;Patients who used corticosteroids ; Patient who are involved in other clinical trials ; Known hypersensitivity to glargine insulin
Age
From 18 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 725
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences , Ghods street , Keshavarz street
City
Tehran
Postal code
Approval date
2011-10-29, 1390/08/07
Ethics committee reference number
1371/130/د/90

Health conditions studied

1

Description of health condition studied
diabetes mellitus type II
ICD-10 code
E10 -E14
ICD-10 code description
diabetes mellitus

Primary outcomes

1

Description
HbA1c changes
Timepoint
before usage of insulin and 6 months after usage
Method of measurement
blood test

Secondary outcomes

1

Description
Hypoglycemia
Timepoint
any time that the attack occurred
Method of measurement
SMBG , blood test

2

Description
Change of insulin doses
Timepoint
after 45 days
Method of measurement
SMBG

3

Description
The percentage of pts achieving HbA1C < %7 at the end of 3 months period.
Timepoint
before usage of insulin and 3 months after usage
Method of measurement
blood test

Intervention groups

1

Description
Intervention 1:Timely initiation & titration of glargine insulin (morning) due to ADA/EASD algorithm
Category
Treatment - Drugs

2

Description
Intervention 2 : Timely initiation & titration of glargine insulin (evening )due to ADA/EASD algorithm
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrine Research Center (Firozgar) , Institute of Endocrinology & Metabolism & 72 center in the co
Full name of responsible person
Dr.Mohammad Ebrahim Khamseh (scientific supervisor )
Street address
Firoozgar hospital , Valadi valley, Valiasr street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanofi Co.
Full name of responsible person
Dr.Elham Mir
Street address
sanofi CO , NO 18 , Alvand street , Arzhantin sqaure
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanofi Co.
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran university of Medical Sciences
Full name of responsible person
Dr.Akbar Fotoohi
Street address
Tehran University of Medical Sciences , Ghods street , Keshavarz street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tehran university of Medical Sciences
Proportion provided by this source
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
Executive Manager & Assistant of Research Endocrine Research Center (Firozgar) , Institute of Endocr
Full name of responsible person
Dr.Laily Najafi
Position
MD
Other areas of specialty/work
Street address
Firoozgar hospital , Valadi valley, Valiasr street,
City
Tehran
Postal code
Phone
+98 21 8894 5247
Fax
Email
L.najafi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrine Research Center (Firozgar) , Institute of Endocrinology & Metabolism
Full name of responsible person
Dr.Mohammad Ebrahim Khamseh
Position
Endocrinologist
Other areas of specialty/work
Street address
Firoozgar hospital , Valadi valley, Valiasr street,
City
Tehran
Postal code
Phone
+98 21 8894 5247
Fax
Email
m-khamseh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Endocrine Research Center (Firozgar) , Institute of Endocrinology & Metabolism
Full name of responsible person
Ameneh Ebrahim Valoojerdi
Position
BA in Statistic
Other areas of specialty/work
Street address
Firoozgar hospital , Valadi valley, Valiasr street,
City
Tehran
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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