<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765359</url>
  </required_header>
  <id_info>
    <org_study_id>Diabetes2017</org_study_id>
    <secondary_id>2016-005031-32</secondary_id>
    <nct_id>NCT03765359</nct_id>
  </id_info>
  <brief_title>Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes.</brief_title>
  <official_title>Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes. A Randomized Double-blind Placebo-controlled Multicenter Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oulu University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helsinki University Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Finland Hospital District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tampere University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates whether additional metformin medication in combination with regular&#xD;
      insulin treatment will decrease the need of insulin for women with diabetes mellitus type 1&#xD;
      during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insulin resistance during pregnancy of diabetes mellitus type 1 patients (DM1) increases the&#xD;
      need for insulin and makes it more difficult to maintain normoglycemia. Fetal exposure to&#xD;
      hyperglycemia induces macrosomia which increases fetal and neonatal morbidity and mortality.&#xD;
      Further more obesity and excess weight gain during pregnancy enhances insulin resistance and&#xD;
      it's an independent risk factor for fetal macrosomia.&#xD;
&#xD;
      Metformin is a medical treatment for type 2 diabetes (DM2) where consequential&#xD;
      pathophysiology includes insulin resistance. It reduces hepatic glucose production and&#xD;
      enhances the use of glucose in muscles relieving insulin resistance. Metformin has also found&#xD;
      to inhibit weight gain effectively.&#xD;
&#xD;
      Metformin has approved to be safe and effective in patients with gestational diabetes (GDM).&#xD;
      It has found to reduce weight gain and improve postprandial blood glucose levels during&#xD;
      pregnancy and reduce neonatal birth trauma in GDM. However, there are no previous studies&#xD;
      about the use of metformin in pregnant women with DM1.&#xD;
&#xD;
      Two hundred women with DM1 will be randomized to get placebo or metformin in addition to&#xD;
      regular insulin treatment. The sample size has been estimated to demonstrate the difference&#xD;
      of 15 % in the need to increase insulin dosages during the pregnancy between the study&#xD;
      groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 5, 2019</start_date>
  <completion_date type="Actual">December 19, 2022</completion_date>
  <primary_completion_date type="Actual">December 19, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the insulin need during pregnancy</measure>
    <time_frame>from 5-10 gestational weeks until the delivery</time_frame>
    <description>The insulin dosage (IU/ml) in two weeks sets</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood glucose balance during pregnancy HbA1c</measure>
    <time_frame>from gestational weeks 5 until the delivery</time_frame>
    <description>HbA1c (mmol/mol)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose balance during pregnancy AVG, SD, CV</measure>
    <time_frame>from gestational weeks 5 until the delivery</time_frame>
    <description>mean blood glucose (mmol/l) level, standard deviation (SD) and the coefficient of variation of the blood glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the weight</measure>
    <time_frame>from gestational weeks 5 until the delivery</time_frame>
    <description>Weight gain (g) during pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the blood pressure</measure>
    <time_frame>from gestational weeks 5 until the delivery</time_frame>
    <description>Blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of pre-eclampsia</measure>
    <time_frame>from gestational weeks 20 until the delivery</time_frame>
    <description>Incidence of pre-eclampsia (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence hepatogestosis</measure>
    <time_frame>from gestational weeks 20 until the delivery</time_frame>
    <description>Incidence hepatogestosis (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>from gestational weeks 5 until the delivery</time_frame>
    <description>Incidence proteinuria (mg/mmol or mg/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>macrosomia</measure>
    <time_frame>from gestational weeks 20 until the delivery</time_frame>
    <description>estimated fetal weight in ultrasound (grams)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>12-22 weeks of gestation</time_frame>
    <description>incidence of miscarriage (intrauterine death before 22 weeks of gestation or fetal weigth under 500g) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>22-40 weeks of gestation</time_frame>
    <description>incidence of intrauterine death (intrauterine death after 22 weeks of gestation or fetal weigth over 500g) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thigh fractional volume ultrasound</measure>
    <time_frame>from gestational weeks 20 until delivery</time_frame>
    <description>Fetal weight estimation (g) is specified by thigh fractional volume ultrasound program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the caesarean sections</measure>
    <time_frame>The delivery</time_frame>
    <description>Rate of the caesarean sections (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Labour</measure>
    <time_frame>The delivery</time_frame>
    <description>rate of spontaneous delivery (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the operative vaginal deliveries</measure>
    <time_frame>The delivery</time_frame>
    <description>Rate of the operative vaginal deliveries (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the shoulder dystocia</measure>
    <time_frame>The delivery</time_frame>
    <description>Rate of the shoulder dystocia (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Labor complications</measure>
    <time_frame>The delivery</time_frame>
    <description>rate of induced delivery (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of the perineal tears</measure>
    <time_frame>The delivery</time_frame>
    <description>Rate of the perineal tears (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postpartum bleeding</measure>
    <time_frame>The delivery</time_frame>
    <description>postpartum bleeding (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn variables (gestational age)</measure>
    <time_frame>After the delivery</time_frame>
    <description>Rate of the premature deliveries (=deliveries before 37 weeks of gestation) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn variables</measure>
    <time_frame>After the delivery</time_frame>
    <description>weight of the newborn (g)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn outcome</measure>
    <time_frame>After the delivery</time_frame>
    <description>Acidosis of the newborn (pH)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn outcome (intensive care)</measure>
    <time_frame>After the delivery</time_frame>
    <description>The need of NICU (neonatal intensive care unit) treatment (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn outcome (hypoglycemia)</measure>
    <time_frame>After the delivery</time_frame>
    <description>The occurrence of hypoglycemia (=plasma glucose under 2.6mmol/l or usage of iv glucose infusion) (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn outcome (Erb's)</measure>
    <time_frame>After the delivery</time_frame>
    <description>Incidence of the Erb's paresis (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (sick leaves)</measure>
    <time_frame>from gestational weeks 12 until delivery</time_frame>
    <description>The need of sick leaves during pregnancy (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (visits to maternity outpatient clinic or internal medicine policlinic)</measure>
    <time_frame>14-40 weeks of gestation</time_frame>
    <description>The need of polyclinical controls during pregnancy (number of visits/pregnancy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (hospitalization)</measure>
    <time_frame>14-40 weeks of gestation</time_frame>
    <description>The need of hospitalization during pregnancy (days/pregnancy)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (all outpatient visits after delivery )</measure>
    <time_frame>One year after the delivery</time_frame>
    <description>The need of policlinical controls of the diabetic mother after the delivery (number of visits)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (hospitalization after delivery, all departments)</measure>
    <time_frame>Up to one year after the delivery</time_frame>
    <description>The need of hospitalization of the diabetic mother after the delivery (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (all hospitalization of the child)</measure>
    <time_frame>Until the age of one year</time_frame>
    <description>The need of hospitalization of the child (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost benefit calculations (all policlinical controls of the child)</measure>
    <time_frame>Until the age of one year</time_frame>
    <description>The need of policlinical controls of the child (number of visits)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>high sensitive-CRP</measure>
    <time_frame>7-10, 26-28 and 34-36 weeks of gestation</time_frame>
    <description>high sensitive-CRP (mg/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lipids</measure>
    <time_frame>7-10, 26-28 and 34-36 weeks of gestation</time_frame>
    <description>cholesterol, high density lipoprotein, low density lipoprotein, triglyserids (mmol/l)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers</measure>
    <time_frame>7-10, 26-28 and 34-36 weeks of gestation</time_frame>
    <description>adiponectin, leptin, resistin, IL-6, TNF-α (pg/ml)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Diabetic Pregnancy</condition>
  <condition>Insulin Resistance</condition>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>metforminhydrochloride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Metformin medication starts on 12-14 weeks of gestation. The starting dosage is 1 tablet (500 mg) x1 and it is increased gradually 1 tablet a week up to 2+2 tablets (2000mg) daily. Duration of the treatment is approximately until one week before delivery. Otherwise metformin treatment combined with regular insulin and follow-up during pregnancy follows the national guidelines.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets starts on 12-14 weeks of gestation. The starting dosage is 1 tablet x1 and it is increased gradually 1 tablet a week up to 2+2 tablets daily. Duration of the treatment is approximately until one week before delivery. Otherwise placebo treatment combined with regular insulin and follow-up during pregnancy follows the national guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>metforminhydrochloride</intervention_name>
    <description>metformin 500 mg tablets and insulin</description>
    <arm_group_label>metforminhydrochloride</arm_group_label>
    <other_name>A10BA02</other_name>
    <other_name>Diformin</other_name>
    <other_name>Metformin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo tablets mimic metformin 500 mg tablets and insulin</description>
    <arm_group_label>Placebo Oral Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a pregnancy of a woman with type 1 diabetes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancy, significant underlying disease (hearth disease, kidney transplant,&#xD;
             IBD (inflammatory bowel disease ), SLE (systemic lupus erythematosus ), diseases with&#xD;
             use of high dosage corticosteroids (severe asthma or rheumatic disease), severe&#xD;
             complications of diabetes (nephropathy, neuropathy, gastroparesis or severe&#xD;
             retinopathy), substance abuse, smoking, BMI &lt;18, strong early pregnancy nausea&#xD;
             (=hyperemesis)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Study is done during pregnancy</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kati Tihtonen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University Hospital, Tampere University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Hospital</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Finland Health Care District</name>
      <address>
        <city>Jyväskylä</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulu University hospital</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>April 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>insulin need</keyword>
  <keyword>diabetic pregnancy</keyword>
  <keyword>insulin resistance</keyword>
  <keyword>metformin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765359
org study id: Diabetes2017
secondary id: 2016-005031-32
nct id: NCT03765359
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study investigates whether additional metformin medication in combination with regular
      insulin treatment will decrease the need of insulin for women with diabetes mellitus type 1
      during pregnancy.
Insulin resistance during pregnancy of diabetes mellitus type 1 patients (DM1) increases the
      need for insulin and makes it more difficult to maintain normoglycemia. Fetal exposure to
      hyperglycemia induces macrosomia which increases fetal and neonatal morbidity and mortality.
      Further more obesity and excess weight gain during pregnancy enhances insulin resistance and
      it's an independent risk factor for fetal macrosomia.

      Metformin is a medical treatment for type 2 diabetes (DM2) where consequential
      pathophysiology includes insulin resistance. It reduces hepatic glucose production and
      enhances the use of glucose in muscles relieving insulin resistance. Metformin has also found
      to inhibit weight gain effectively.

      Metformin has approved to be safe and effective in patients with gestational diabetes (GDM).
      It has found to reduce weight gain and improve postprandial blood glucose levels during
      pregnancy and reduce neonatal birth trauma in GDM. However, there are no previous studies
      about the use of metformin in pregnant women with DM1.

      Two hundred women with DM1 will be randomized to get placebo or metformin in addition to
      regular insulin treatment. The sample size has been estimated to demonstrate the difference
      of 15 % in the need to increase insulin dosages during the pregnancy between the study
      groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: placebo controlled
measure: Changes in the insulin need during pregnancy
time frame: from 5-10 gestational weeks until the delivery
description: The insulin dosage (IU/ml) in two weeks sets
measure: Blood glucose balance during pregnancy HbA1c
time frame: from gestational weeks 5 until the delivery
description: HbA1c (mmol/mol)
measure: Blood glucose balance during pregnancy AVG, SD, CV
time frame: from gestational weeks 5 until the delivery
description: mean blood glucose (mmol/l) level, standard deviation (SD) and the coefficient of variation of the blood glucose levels
measure: Change in the weight
time frame: from gestational weeks 5 until the delivery
description: Weight gain (g) during pregnancy
measure: Change in the blood pressure
time frame: from gestational weeks 5 until the delivery
description: Blood pressure (mmHg)
measure: Incidence of pre-eclampsia
time frame: from gestational weeks 20 until the delivery
description: Incidence of pre-eclampsia (%)
measure: Incidence hepatogestosis
time frame: from gestational weeks 20 until the delivery
description: Incidence hepatogestosis (%)
measure: Pregnancy complications
time frame: from gestational weeks 5 until the delivery
description: Incidence proteinuria (mg/mmol or mg/d)
measure: macrosomia
time frame: from gestational weeks 20 until the delivery
description: estimated fetal weight in ultrasound (grams)
measure: Pregnancy complications
time frame: 12-22 weeks of gestation
description: incidence of miscarriage (intrauterine death before 22 weeks of gestation or fetal weigth under 500g) (%)
measure: Pregnancy complications
time frame: 22-40 weeks of gestation
description: incidence of intrauterine death (intrauterine death after 22 weeks of gestation or fetal weigth over 500g) (%)
measure: Thigh fractional volume ultrasound
time frame: from gestational weeks 20 until delivery
description: Fetal weight estimation (g) is specified by thigh fractional volume ultrasound program
measure: Rate of the caesarean sections
time frame: The delivery
description: Rate of the caesarean sections (%)
measure: Labour
time frame: The delivery
description: rate of spontaneous delivery (%)
measure: Rate of the operative vaginal deliveries
time frame: The delivery
description: Rate of the operative vaginal deliveries (%)
measure: Rate of the shoulder dystocia
time frame: The delivery
description: Rate of the shoulder dystocia (%)
measure: Labor complications
time frame: The delivery
description: rate of induced delivery (%)
measure: Rate of the perineal tears
time frame: The delivery
description: Rate of the perineal tears (%)
measure: Postpartum bleeding
time frame: The delivery
description: postpartum bleeding (ml)
measure: Newborn variables (gestational age)
time frame: After the delivery
description: Rate of the premature deliveries (=deliveries before 37 weeks of gestation) (%)
measure: Newborn variables
time frame: After the delivery
description: weight of the newborn (g)
measure: Newborn outcome
time frame: After the delivery
description: Acidosis of the newborn (pH)
measure: Newborn outcome (intensive care)
time frame: After the delivery
description: The need of NICU (neonatal intensive care unit) treatment (days)
measure: Newborn outcome (hypoglycemia)
time frame: After the delivery
description: The occurrence of hypoglycemia (=plasma glucose under 2.6mmol/l or usage of iv glucose infusion) (%)
measure: Newborn outcome (Erb's)
time frame: After the delivery
description: Incidence of the Erb's paresis (%)
measure: Cost benefit calculations (sick leaves)
time frame: from gestational weeks 12 until delivery
description: The need of sick leaves during pregnancy (days)
measure: Cost benefit calculations (visits to maternity outpatient clinic or internal medicine policlinic)
time frame: 14-40 weeks of gestation
description: The need of polyclinical controls during pregnancy (number of visits/pregnancy)
measure: Cost benefit calculations (hospitalization)
time frame: 14-40 weeks of gestation
description: The need of hospitalization during pregnancy (days/pregnancy)
measure: Cost benefit calculations (all outpatient visits after delivery )
time frame: One year after the delivery
description: The need of policlinical controls of the diabetic mother after the delivery (number of visits)
measure: Cost benefit calculations (hospitalization after delivery, all departments)
time frame: Up to one year after the delivery
description: The need of hospitalization of the diabetic mother after the delivery (days)
measure: Cost benefit calculations (all hospitalization of the child)
time frame: Until the age of one year
description: The need of hospitalization of the child (days)
measure: Cost benefit calculations (all policlinical controls of the child)
time frame: Until the age of one year
description: The need of policlinical controls of the child (number of visits)
measure: high sensitive-CRP
time frame: 7-10, 26-28 and 34-36 weeks of gestation
description: high sensitive-CRP (mg/l)
measure: lipids
time frame: 7-10, 26-28 and 34-36 weeks of gestation
description: cholesterol, high density lipoprotein, low density lipoprotein, triglyserids (mmol/l)
measure: Inflammatory markers
time frame: 7-10, 26-28 and 34-36 weeks of gestation
description: adiponectin, leptin, resistin, IL-6, TNF-α (pg/ml)
arm group label: metforminhydrochloride
arm group type: Active Comparator
description: Metformin medication starts on 12-14 weeks of gestation. The starting dosage is 1 tablet (500 mg) x1 and it is increased gradually 1 tablet a week up to 2+2 tablets (2000mg) daily. Duration of the treatment is approximately until one week before delivery. Otherwise metformin treatment combined with regular insulin and follow-up during pregnancy follows the national guidelines.
arm group label: Placebo Oral Tablet
arm group type: Placebo Comparator
description: Placebo tablets starts on 12-14 weeks of gestation. The starting dosage is 1 tablet x1 and it is increased gradually 1 tablet a week up to 2+2 tablets daily. Duration of the treatment is approximately until one week before delivery. Otherwise placebo treatment combined with regular insulin and follow-up during pregnancy follows the national guidelines.
intervention type: Drug
intervention name: metforminhydrochloride
description: metformin 500 mg tablets and insulin
arm group label: metforminhydrochloride
other name: A10BA02
other name: Diformin
other name: Metformin
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo tablets mimic metformin 500 mg tablets and insulin
arm group label: Placebo Oral Tablet
criteria: 
gender: Female
gender based: Yes
gender description: Study is done during pregnancy
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kati Tihtonen, PhD
role: Principal Investigator
affiliation: Tampere University Hospital, Tampere University
facility: 
facility: 
facility: 
facility: 
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Resistance
mesh term: Metformin
sharing ipd: No