Metformin Versus Insulin in Gestational Diabetes

NCT01240785 | Completed Phase 4 Results

• 1 other identifier: 246/2005
• Study Type: interventional
• Target: 221
• Locations: 0 countries
• Sites: N/A

Brief 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. The investigators hypothesis is that there is no difference between insulin and metformin treated mothers in the main outcome criteria (birth weight, neonatal complications).

Conditions

Gestational Diabetes

Keywords

gestational diabetes; metformin; insulin

Outcome Measures

Primary Outcomes (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

  delivery

Secondary Outcomes (12)

• Pregnancy Induced Hypertension Per Arm

  up to on the average 40 weeks of gestation

• Maternal Weight Gain Per Arm

  up to on the average 40 weeks of gestation

• Pre-eclampsia Per Arm

  up to on the average 40 weeks of gestation

• Mode of Delivery Per Arm

  delivery

• Gestational Weeks at Delivery Per Arm

  delivery

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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

Drug: metformin

insulin

ACTIVE COMPARATOR

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

Drug: insulin

Interventions

metformin DRUG

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

Also known as: Diformin retard 500 mg

Metformin

insulin DRUG

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

Also known as: Protaphane, Humalog

insulin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Related Publications (5)

• 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.

  PMID: 34059525 DERIVED

• 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.

  PMID: 32652973 DERIVED

• 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.

  PMID: 30227169 DERIVED

• 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.

  PMID: 26439816 DERIVED

• 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.

  PMID: 24633859 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Metformin; Insulin; Insulin Lispro

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Dr Kristiina Tertti
• Organization: Department of Obstetrics and Gynecology, Turku University Central Hospital

kristiina.tertti@tyks.fi

+358 2 3130000

Study Officials

• Tapani Rönnemaa, MD, PhD

  Professor, Chief Physician

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 3, 2010
• First Posted: November 15, 2010
• Study Start: June 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2012
• Last Updated: November 24, 2014
• Results First Posted: November 24, 2014

Record last verified: 2014-11