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Metformin Versus Insulin in Gestational Diabetes

NCT ID: NCT01240785

Last Updated: 2014-11-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values

Group Type ACTIVE_COMPARATOR

metformin

Intervention Type DRUG

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

insulin

NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values

Group Type ACTIVE_COMPARATOR

insulin

Intervention Type DRUG

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

Interventions

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metformin

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

Intervention Type DRUG

insulin

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

Intervention Type DRUG

Other Intervention Names

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Diformin retard 500 mg Protaphane Humalog

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tapani Rönnemaa

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tapani Rönnemaa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Chief Physician

References

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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.

Reference Type DERIVED
PMID: 34059525 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32652973 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30227169 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26439816 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24633859 (View on PubMed)

Other Identifiers

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246/2005

Identifier Type: -

Identifier Source: org_study_id