AzTrials
AzTrials

Gestational DiabetesPhase 4NCT01240785

Metformin Versus Insulin in Gestational Diabetes

A Phase 4 study testing metformin and insulin in people with Gestational Diabetes, run by Turku University Hospital.

Completed

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

Official record
Search all trials

Trial summary

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Gestational Diabetes
What is being tested?
metformin and insulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
221 participants
Where
No sites listed yet
Study dates
Jun 2006to Dec 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks

Who cannot join

  • Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
  • Renal, hepatic or cardiac failure
  • Pregestational use of metformin
  • Pregnancy with multiple fetuses

About this study

Official title: Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).

Read the detailed description

Gestational diabetes is traditionally treated with insulin. Metformin is a peroral drug used worldwide in the treatment of type 2 diabetes and also in a few studies on patients with gestational diabetes. The investigators aim is to compare insulin and metformin in the treatment of gestational diabetes. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications). The study was performed as a randomized controlled trial in one center, Turku University hospital using the non-inferiority design in June 2006 - December 2010. The final study population consisted of altogether 217 women, of whom 110 received metformin and 107 insulin.

Being tested
metformin, insulin
Keywords
gestational diabetes, metformin, insulin
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.

  • metforminDrug

    Also called Diformin retard 500 mg

    metformin 1 g twice daily or maximum tolerated dose less than 2 g daily

  • insulinDrug

    Also called Protaphane, Humalog

    subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

Study groups in NCT01240785
Study groupRoleWhat they receive
MetforminActive comparatorMetformin 500 mg 1-2 tablets twice daily according to plasma glucose values
Receives: Drug: metformin
insulinActive comparatorNPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values
Receives: Drug: insulin

What is being measured

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

  1. Birth Weight Per Arm

    birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies

    Measured: delivery

Secondary outcomes (12)

  1. Pregnancy Induced Hypertension Per Arm

    Participants with pregnancy induced hypertension defined as blood pressure over 140/90 mmHg or increase in systolic blood pressure > 30 mmHg or diastolic blood pressure > 15 mmHg

    Measured: up to on the average 40 weeks of gestation

  2. Maternal Weight Gain Per Arm

    Measured: up to on the average 40 weeks of gestation

  3. Pre-eclampsia Per Arm

    Measured: up to on the average 40 weeks of gestation

  4. Mode of Delivery Per Arm

    Measured: delivery

  5. Gestational Weeks at Delivery Per Arm

    Measured: delivery

  6. Induction of Delivery Per Arm

    Measured: delivery

  7. Shoulder Dystocia Per Arm

    Measured: delivery

  8. Neonatal Hypoglycemia Per Arm

    Measured: 0-24 h after delivery

  9. Neonatal Hyperbilirubinemia Per Arm

    Measured: 0-3 days after delivery

  10. Apgar Score at 5 Min After Delivery Per Arm

    Apgar score 0-10. 0-2 points from heart rate; 0-2 points for respiratory effort; 0-2 points for skin colour; 0-2 points for muscle tone; 0-2 points for reflex response. For all items the higher the value, the better the outcome

    Measured: 5 minutes after delivery

  11. Neonate Transfer to Intensive Care Unit Per Arm

    Measured: 0-5 days after delivery

  12. Child Outcome at 2 Years Per Arm

    neuropsychological and motor skills testing

    Measured: 2 years after birth

Timeline

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

  1. First posted15 Nov 2010 (estimated)
  2. Study startJun 2006
  3. Primary completionJan 2011
  4. Study completionDec 2012

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
None (open label)
Enrolment
221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01240785
Sponsor's protocol ID
246/2005
Status last verified
Nov 2014
First submitted
3 Nov 2010
Last updated
24 Nov 2014
Data monitoring committee
No

Publications

  • Huhtala MS, Ronnemaa T, Pellonpera O, Tertti K. Cord serum metabolome and birth weight in patients with gestational diabetes treated with metformin, insulin, or diet alone. BMJ Open Diabetes Res Care. 2021 May;9(1):e002022. doi: 10.1136/bmjdrc-2020-002022.

    PubMed 34059525

  • Huhtala MS, Tertti K, Juhila J, Sorsa T, Ronnemaa T. Metformin and insulin treatment of gestational diabetes: effects on inflammatory markers and IGF-binding protein-1 - secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2020 Jul 11;20(1):401. doi: 10.1186/s12884-020-03077-6.

    PubMed 32652973

  • Huhtala MS, Tertti K, Pellonpera O, Ronnemaa T. Amino acid profile in women with gestational diabetes mellitus treated with metformin or insulin. Diabetes Res Clin Pract. 2018 Dec;146:8-17. doi: 10.1016/j.diabres.2018.09.014. Epub 2018 Sep 15.

    PubMed 30227169

  • Pellonpera O, Ronnemaa T, Ekblad U, Vahlberg T, Tertti K. The effects of metformin treatment of gestational diabetes on maternal weight and glucose tolerance postpartum--a prospective follow-up study. Acta Obstet Gynecol Scand. 2016 Jan;95(1):79-87. doi: 10.1111/aogs.12788. Epub 2015 Nov 8.

    PubMed 26439816

  • Tertti K, Laine K, Ekblad U, Rinne V, Ronnemaa T. The degree of fetal metformin exposure does not influence fetal outcome in gestational diabetes mellitus. Acta Diabetol. 2014 Oct;51(5):731-8. doi: 10.1007/s00592-014-0570-6. Epub 2014 Mar 16.

    PubMed 24633859

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metformin and insulin in people with Gestational Diabetes, run by Turku University Hospital.

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 4 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Birth Weight Per Arm (time frame: 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 NCT01240785, which also lists 5 linked publications.

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 24 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in