NCT03765359

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2019

Typical duration for phase_4

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2022

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

3.4 years

First QC Date

April 24, 2018

Last Update Submit

June 6, 2023

Conditions

Diabetic PregnancyInsulin ResistanceType1diabetes

Keywords

insulin needdiabetic pregnancyinsulin resistancemetformin

Outcome Measures

Primary Outcomes (1)

  • Changes in the insulin need during pregnancy

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

    from 5-10 gestational weeks until the delivery

Secondary Outcomes (34)

  • Blood glucose balance during pregnancy HbA1c

    from gestational weeks 5 until the delivery

  • Blood glucose balance during pregnancy AVG, SD, CV

    from gestational weeks 5 until the delivery

  • Change in the weight

    from gestational weeks 5 until the delivery

  • Change in the blood pressure

    from gestational weeks 5 until the delivery

  • Incidence of pre-eclampsia

    from gestational weeks 20 until the delivery

  • +29 more secondary outcomes

Study Arms (2)

metforminhydrochloride

ACTIVE COMPARATOR

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.

Drug: metforminhydrochloride

Placebo Oral Tablet

PLACEBO COMPARATOR

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.

Drug: Placebo Oral Tablet

Interventions

metforminhydrochlorideDRUG

metformin 500 mg tablets and insulin

Also known as: A10BA02, Diformin, Metformin
metforminhydrochloride
Placebo Oral TabletDRUG

Placebo tablets mimic metformin 500 mg tablets and insulin

Placebo Oral Tablet

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy is done during pregnancy
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a pregnancy of a woman with type 1 diabetes.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Helsinki University Hospital

Helsinki, Finland

Location

Central Finland Health Care District

Jyväskylä, Finland

Location

Oulu University hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

  • 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.

    PMID: 40916351DERIVED

MeSH Terms

Conditions

Diabetes, GestationalInsulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Kati Tihtonen, PhD

    Tampere University Hospital, Tampere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
placebo controlled
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2018

First Posted

December 5, 2018

Study Start

August 5, 2019

Primary Completion

December 19, 2022

Study Completion

December 19, 2022

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FI(5)