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Monitoring the efficacy and safety of lantus in t2 patients failing glycemic control with premix or NPH with OAD or short acting insulin

Protocol summary

Summary
Study Objectives:Primary: To show decrease in HbA1c in patients switching to Lantus after failure on Premix based insulin regimens or NPH based insulin regimens. Secondary: To illustrate the number of patients achieved better glycemic control (HgA1C<7) Drug safety evaluation in this population STUDY DESIGN: The study is an observational, non-controlled, open-label, multi centre, prospective product registry inclusion Diabetes Mellitus type 2 ,Age: 19 ≤ age ≤ 79,Patients who previously failed to achieve a glycemic control (HbA1c ≥ 7 %; ADA, EASD.) under premixesi nsulin BD or NPH with OAD or short acting insulins.,Patients must sign the informed consent. exclusion : Patients with severe renal failure and haemodialysis, Patients with sever Hepatic failure, Pregnancy or Breast feeding, Mental disorders, Hypersensitivity to basal insulin, Inability to perform SMBG Number of patients Total Patients recruitment will be 230 subjects Primary efficacy endpoints: HbA1c level each visit.,Fasting Blood glucose level each visit

General information

Acronym
impress
IRCT registration information
IRCT registration number: IRCT2012110411356N1
Registration date: 2012-11-18, 1391/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-18, 1391/08/28
Registrant information
Name
Alireza Esteghamati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8841 7918
Email address
esteghamati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sanofi Aventis as sponsor
Expected recruitment start date
2011-12-01, 1390/09/10
Expected recruitment end date
2012-06-02, 1391/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Monitoring the efficacy and safety of lantus in t2 patients failing glycemic control with premix or NPH with OAD or short acting insulin
Public title
Monitoring the efficacy and safety of lantus in t2 patients failing glycemic control with premix or NPH with OAD or short acting insulin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: suffering from diabetes Mellitus type 2; agebetween 19 to 79 years ; patients who previously failed to achieve a glycemic control (HbA1c ≥ 7 %; ADA, EASD.) under premixesi nsulin BD or NPH with OAD or short acting insulins and patients must sign the informed consent. Exclusion criteria: patients with severe renal failure and haemodialysis; patients with sever hepatic failure, pregnancy or breast feeding; mental disorders; hypersensitivity to basal insulin and inability to perform SMBG.
Age
From 19 years old to 79 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 230
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
Endocrinology and metabolism research institute
Street address
tehran university
City
Tehran
Postal code
Approval date
2011-12-28, 1390/10/07
Ethics committee reference number
E-00171

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
HbA1c level each visit.
Timepoint
24 weeks
Method of measurement
choromotography

Secondary outcomes

1

Description
Proportion of patients reaching the glycemic control
Timepoint
24 weeks
Method of measurement
choromatography

Intervention groups

1

Description
glargyn(lantus) The investigator will determine the dosage of insulin glargine according to his needs & based on his other concomitant treatments. The insulin dosage of patients will be up titrated according to standard care practices.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Esteghamati 's private clinic
Full name of responsible person
Alireza Esteghamati
Street address
Motahari st. Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanofi Aventis
Full name of responsible person
Seyed Ehsan Mirrezaei
Street address
No.18, 35th st., Alvand st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanofi Aventis
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
Sanofi Aventis
Full name of responsible person
Elham Mir
Position
Medical clinical research manager
Other areas of specialty/work
Street address
No.18, 35th st., Alvand st.
City
Tehran
Postal code
Phone
+98 21 8864 9710
Fax
Email
Elham.Mir@iran.sanofi-aventis.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Esteghamati
Position
Principle investigator, Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 8864 9710
Fax
Email
esteghamati@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sanofi Aventis
Full name of responsible person
Seyed Ehsan Mirrezaei
Position
Clinical research associate
Other areas of specialty/work
Street address
No.18, 35th st., Alvand st.
City
Tehran
Postal code
Phone
+98 21 8864 9710
Fax
Email
Ehsan.Mirrezaei-ext@iran.sanofi-aventis.com
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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