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comparison of the effect of insulin glargine on glycemic control when combined with either metformin or acarbose in Type 2 diabetic patients

Protocol summary

Summary
Abstract Purpose: the analysis of the impact of insulin glargine and acarbose compared to insulin glargine and metformin in patients with type II diabetes Design: randomized clinical trial, double-blind, placebo-controlled loading, single-center Procedure: 152 patients with diabetes are divided to four groups with balanced dynamic randomization where each group contains 38 individuals. The first group (group A) uses placebo metformin and placebo Acarbose. The second group (group B) takes 500-mgl metformin pills every night; the drug dose increases for 2 grams every week, and they also use placebo Acarbose. The third group (group C) use 100 mg of Acarbose pill. The dose in the first week is 50 and then 100 mg for each meal (utmost daily doze is 300 mg); they also use metformin placebo. The fourth group (group D) uses metformin and Acarbose pill. Diet and sport is prescribed for all of the groups. Their blood is analyzed and they are clinically examined. A questionnaire is also distributed among them. Participants: Diabetes patients who refer to clinic (criteria for inclusion: type II diabetes, age range of 18-75, exclusion criteria: suffering from chronic diseases, the consumption of insulin) Interference: The prescription of Acarbose, Metformin prescription Major outcome: Fasting blood glucose, blood sugar two hours after breakfast, glycosylated hemoglobin, creatinine, triglycerides, cholesterol, high density lipoprotein, alanine aminotransferase, aspartate aminotransferase

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201403041774N6
Registration date: 2014-12-07, 1393/09/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences; Exir Pharmaceutical Company;fareer asa teb Pharmaceutical Company
Expected recruitment start date
2014-08-02, 1393/05/11
Expected recruitment end date
2016-01-31, 1394/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of insulin glargine on glycemic control when combined with either metformin or acarbose in Type 2 diabetic patients
Public title
Insulin glargine and acarbose in the treatment of type II diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Type 2 diabetes (based on American Diabetes Association criteria) 2. age group 18-75 years 3. Enough acuity and alertness to injection of insulin 4. no glycemic control with oral medications Exclusion criteria: 1. Chronic Complications of Diabetes 2. Pregnancy 3. Breastfeeding 4. Liver Disease 5. kidney disease 6. neurological disease 7. chronic inflammatory disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Vice chancellor for Research and Technology of kerman university of medical science
Street address
In front of Besat clinic, the begining of Ebn-e-Sina street, the begining of Jahad Boulevard, Tahmasb Abad crossroads, Physiology research center, Vice chancellor for Research and Technology of University of Medical Sciences, kerman
City
kerman
Postal code
Approval date
2013-12-04, 1392/09/13
Ethics committee reference number
K.92.318

Health conditions studied

1

Description of health condition studied
Diabet mellitus
ICD-10 code
E11
ICD-10 code description
non insulin dependent diabetes mellitus

Primary outcomes

1

Description
Plasma glucose
Timepoint
During of study
Method of measurement
Blood sample

2

Description
HbA1c
Timepoint
0, 90
Method of measurement
Blood sample

3

Description
Hypoglycemia
Timepoint
Self - monitoring of blood glucose
Method of measurement
Questionnaire and blood tests during raid

Secondary outcomes

1

Description
Laboratory Tests
Timepoint
Before and one month, two months, three months after the intervention
Method of measurement
blood and urine sample

2

Description
Weight and blood prussre and others
Timepoint
Before and one month, two months, three months after the intervention
Method of measurement
Barometer system and standard weight

Intervention groups

1

Description
The first group (group A) uses placebo metformin and placebo Acarbose
Category
Placebo

2

Description
The second group (group B) takes 500-mgl metformin pills every night; the drug dose increases for 2 grams every week, and they also use placebo Acarbose.
Category
Placebo

3

Description
The third group (group C) use 100 mg of Acarbose pill. The dose in the first week is 50 and then 100 mg for each meal (utmost daily doze is 300 mg); they also use metformin placebo.
Category
Placebo

4

Description
The fourth group (group D) uses metformin and Acarbose pill.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman Afzalipour Hospital
Full name of responsible person
Mehrnaz soltani nejad
Street address
AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physiology research center, Vice chancellor for Research and Technology of kerman medical University
Full name of responsible person
Dr.Hamid Najafi pour
Street address
Physiology research center, Vice chancellor for Research and Technology of University of Medical Sciences, In front of Besat clinic, the begining of Ebn-e-Sina street, the begining of Jahad Boulevard, Tahmasb Abad crossroads, Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physiology research center, Vice chancellor for Research and Technology of kerman medical University
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
Excir company
Full name of responsible person
Romiia Javadi
Street address
22, Rahmati alley, Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Excir company
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
Associated professor
Full name of responsible person
Dr. Mojgan Sanjari
Position
Kerman Afzalipour Hospital
Other areas of specialty/work
Street address
AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman
City
kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
+98 34 1211 3426
Email
msanjari@kmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman Afzalipour Hospital
Full name of responsible person
Dr. Mojgan Sanjari
Position
Associated professor
Other areas of specialty/work
Street address
AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman
City
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
+98 34 1322 2763
Email
msanjari@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman Afzalipour Hospital
Full name of responsible person
Dr. Mojgan Sanjari
Position
Associated Professor
Other areas of specialty/work
Street address
AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman
City
Kerman
Postal code
7616913911
Phone
+98 34 1322 2250
Fax
+98 34 1322 2763
Email
msanjari@kmu.ac.ir
Web page address
http://www.kmu.ac.ir/sitewizard/admin/wizard/Default.Aspx?PageId=3089

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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