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Diabetic PregnancyPhase 4NCT03765359

Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes.

A Phase 4 study testing metforminhydrochloride in people with Diabetic Pregnancy and Insulin Resistance, run by Tampere University Hospital at 5 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
metforminhydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
5 sitesFinland
Study dates
5 Aug 2019to 19 Dec 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • a pregnancy of a woman with type 1 diabetes.

Who cannot join

  • multiple pregnancy, significant underlying disease (hearth disease, kidney transplant, IBD (inflammatory bowel disease ), SLE (systemic lupus erythematosus ), diseases with use of high dosage corticosteroids (severe asthma or rheumatic disease), severe complications of diabetes (nephropathy, neuropathy, gastroparesis or severe retinopathy), substance abuse, smoking, BMI <18, strong early pregnancy nausea (=hyperemesis)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Finland5 sites

  • Helsinki University Hospital

    Helsinki

  • Central Finland Health Care District

    Jyväskylä

  • Oulu University hospital

    Oulu

  • Tampere University Hospital

    Tampere

  • Turku University Hospital

    Turku

Other trials in Finland

About this study

Official title: Metformin Use to Improve Pregnancy Outcome in Women With Type 1 Diabetes. A Randomized Double-blind Placebo-controlled Multicenter Study.

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.

Read the detailed description

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.

Being tested
metforminhydrochloride, Placebo Oral Tablet
Keywords
insulin need, diabetic pregnancy, insulin resistance, metformin
Medical subject headings
Diabetes, Gestational, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metforminhydrochlorideDrug

    Also called A10BA02, Diformin, Metformin

    metformin 500 mg tablets and insulin

  • Placebo Oral TabletDrug

    Placebo tablets mimic metformin 500 mg tablets and insulin

Study groups in NCT03765359
Study groupRoleWhat they receive
metforminhydrochlorideActive comparatorMetformin 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.
Receives: Drug: metforminhydrochloride
Placebo Oral TabletPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the insulin need during pregnancy

    The insulin dosage (IU/ml) in two weeks sets

    Measured: from 5-10 gestational weeks until the delivery

Secondary outcomes (34)

  1. Blood glucose balance during pregnancy HbA1c

    HbA1c (mmol/mol)

    Measured: from gestational weeks 5 until the delivery

  2. Blood glucose balance during pregnancy AVG, SD, CV

    mean blood glucose (mmol/l) level, standard deviation (SD) and the coefficient of variation of the blood glucose levels

    Measured: from gestational weeks 5 until the delivery

  3. Change in the weight

    Weight gain (g) during pregnancy

    Measured: from gestational weeks 5 until the delivery

  4. Change in the blood pressure

    Blood pressure (mmHg)

    Measured: from gestational weeks 5 until the delivery

  5. Incidence of pre-eclampsia

    Incidence of pre-eclampsia (%)

    Measured: from gestational weeks 20 until the delivery

  6. Incidence hepatogestosis

    Incidence hepatogestosis (%)

    Measured: from gestational weeks 20 until the delivery

  7. Pregnancy complications

    Incidence proteinuria (mg/mmol or mg/d)

    Measured: from gestational weeks 5 until the delivery

  8. macrosomia

    estimated fetal weight in ultrasound (grams)

    Measured: from gestational weeks 20 until the delivery

  9. Pregnancy complications

    incidence of miscarriage (intrauterine death before 22 weeks of gestation or fetal weigth under 500g) (%)

    Measured: 12-22 weeks of gestation

  10. Pregnancy complications

    incidence of intrauterine death (intrauterine death after 22 weeks of gestation or fetal weigth over 500g) (%)

    Measured: 22-40 weeks of gestation

  11. Thigh fractional volume ultrasound

    Fetal weight estimation (g) is specified by thigh fractional volume ultrasound program

    Measured: from gestational weeks 20 until delivery

  12. Rate of the caesarean sections

    Rate of the caesarean sections (%)

    Measured: The delivery

  13. Labour

    rate of spontaneous delivery (%)

    Measured: The delivery

  14. Rate of the operative vaginal deliveries

    Rate of the operative vaginal deliveries (%)

    Measured: The delivery

  15. Rate of the shoulder dystocia

    Rate of the shoulder dystocia (%)

    Measured: The delivery

  16. Labor complications

    rate of induced delivery (%)

    Measured: The delivery

  17. Rate of the perineal tears

    Rate of the perineal tears (%)

    Measured: The delivery

  18. Postpartum bleeding

    postpartum bleeding (ml)

    Measured: The delivery

  19. Newborn variables (gestational age)

    Rate of the premature deliveries (=deliveries before 37 weeks of gestation) (%)

    Measured: After the delivery

  20. Newborn variables

    weight of the newborn (g)

    Measured: After the delivery

  21. Newborn outcome

    Acidosis of the newborn (pH)

    Measured: After the delivery

  22. Newborn outcome (intensive care)

    The need of NICU (neonatal intensive care unit) treatment (days)

    Measured: After the delivery

  23. Newborn outcome (hypoglycemia)

    The occurrence of hypoglycemia (=plasma glucose under 2.6mmol/l or usage of iv glucose infusion) (%)

    Measured: After the delivery

  24. Newborn outcome (Erb's)

    Incidence of the Erb's paresis (%)

    Measured: After the delivery

  25. Cost benefit calculations (sick leaves)

    The need of sick leaves during pregnancy (days)

    Measured: from gestational weeks 12 until delivery

  26. Cost benefit calculations (visits to maternity outpatient clinic or internal medicine policlinic)

    The need of polyclinical controls during pregnancy (number of visits/pregnancy)

    Measured: 14-40 weeks of gestation

  27. Cost benefit calculations (hospitalization)

    The need of hospitalization during pregnancy (days/pregnancy)

    Measured: 14-40 weeks of gestation

  28. Cost benefit calculations (all outpatient visits after delivery )

    The need of policlinical controls of the diabetic mother after the delivery (number of visits)

    Measured: One year after the delivery

  29. Cost benefit calculations (hospitalization after delivery, all departments)

    The need of hospitalization of the diabetic mother after the delivery (days)

    Measured: Up to one year after the delivery

  30. Cost benefit calculations (all hospitalization of the child)

    The need of hospitalization of the child (days)

    Measured: Until the age of one year

  31. Cost benefit calculations (all policlinical controls of the child)

    The need of policlinical controls of the child (number of visits)

    Measured: Until the age of one year

  32. high sensitive-CRP

    high sensitive-CRP (mg/l)

    Measured: 7-10, 26-28 and 34-36 weeks of gestation

  33. lipids

    cholesterol, high density lipoprotein, low density lipoprotein, triglyserids (mmol/l)

    Measured: 7-10, 26-28 and 34-36 weeks of gestation

  34. Inflammatory markers

    adiponectin, leptin, resistin, IL-6, TNF-α (pg/ml)

    Measured: 7-10, 26-28 and 34-36 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start5 Aug 2019
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03765359
Sponsor's protocol ID
Diabetes2017
Other IDs
2016-005031-32, 2016
Status last verified
Jun 2023
First submitted
24 Apr 2018
Last updated
7 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Juuma E, Tihtonen K, Metso SE, Hannula PM, Helminen M, Tertti K, Immonen H, Georgiadis L, Vayrynen K, Ahtiainen P, Nikkinen H, Koivikko M, Laivuori H, Uotila J. The Effect of Metformin on Insulin Requirement, Glycaemic Control and Weight Gain in Type 1 Diabetes During Pregnancy-a Randomised, Placebo-Controlled Multicentre Study. Diabetes Metab Res Rev. 2025 Sep;41(6):e70085. doi: 10.1002/dmrr.70085.

    PubMed 40916351

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metforminhydrochloride in people with Diabetic Pregnancy and Insulin Resistance, run by Tampere University Hospital at 5 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the insulin need during pregnancy (time frame: from 5-10 gestational weeks until the delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03765359, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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