<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201403041774N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-12-07</date_registration>
      <primary_sponsor>Physiology research center, Vice chancellor for Research and Technology of kerman medical University</primary_sponsor>
      <public_title>Insulin glargine and acarbose in the treatment of type II diabetes</public_title>
      <acronym></acronym>
      <scientific_title>comparison of the effect of insulin glargine on glycemic control when combined with either metformin or acarbose in Type 2 diabetic patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>152</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Diabet mellitus.</hc_freetext>
      <i_freetext>Intervention 1: The first group (group A) uses placebo metformin and placebo Acarbose. Intervention 2: 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. Intervention 3: 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. Intervention 4: The fourth group (group D) uses metformin and Acarbose pill.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mojgan Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34 1322 2250</telephone>
        <email>msanjari@kmu.ac.ir</email>
        <affiliation>Associated professor</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mojgan Sanjari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>AfzaliPour Hospital, Adjacent to Bahonar University, AfzaliPour Landscape, Imam highway, Kerman</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913911</zip>
        <telephone>+98 34 1322 2250</telephone>
        <email>msanjari@kmu.ac.ir</email>
        <affiliation>Kerman Afzalipour Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
1. Type 2 diabetes (based on American Diabetes Association criteria) &#13;
2. age group 18-75 years &#13;
3. Enough acuity and alertness to injection of insulin &#13;
4. no glycemic control with oral medications&#13;
Exclusion criteria:&#13;
1. Chronic Complications of Diabetes &#13;
2. Pregnancy &#13;
3. Breastfeeding &#13;
4. Liver Disease &#13;
5. kidney disease &#13;
6. neurological disease &#13;
7. chronic inflammatory disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>non insulin dependent diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group (group A) uses placebo metformin and placebo Acarbose</i_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>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.</i_keyword>
      <i_keyword>The fourth group (group D) uses metformin and Acarbose pill.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Plasma glucose. Timepoint: During of study. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>HbA1c. Timepoint: 0, 90. Method of measurement: Blood sample.</prim_outcome>
      <prim_outcome>Hypoglycemia. Timepoint: Self - monitoring of blood glucose. Method of measurement: Questionnaire and blood tests during raid.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Laboratory Tests. Timepoint: Before and one month, two months, three months after the intervention. Method of measurement: blood and urine sample.</sec_outcome>
      <sec_outcome>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.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Excir company</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Physiology research center, Vice chancellor for Research and Technology of kerman medical University</source_name>
      <source_name>Excir company</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-12-04</approval_date>
        <contact_name>Ethics Committee Vice chancellor for Research and Technology of kerman university of medical science</contact_name>
        <contact_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 kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
