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NCT Number: NCT01240785

Metformin Versus Insulin in Gestational Diabetes

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).

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

metformin

Drug

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

Other names: Diformin retard 500 mg

Insulin

Drug

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

Other names: Protaphane, Humalog

Primary outcomes

  1. Birth Weight Per Arm

    Time frame: delivery

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

Secondary outcomes

  1. Pregnancy Induced Hypertension Per Arm

    Time frame: up to on the average 40 weeks of gestation

    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

  2. Maternal Weight Gain Per Arm

    Time frame: up to on the average 40 weeks of gestation

  3. Pre-eclampsia Per Arm

    Time frame: up to on the average 40 weeks of gestation

  4. Mode of Delivery Per Arm

    Time frame: delivery

  5. Gestational Weeks at Delivery Per Arm

    Time frame: delivery

  6. Induction of Delivery Per Arm

    Time frame: delivery

  7. Shoulder Dystocia Per Arm

    Time frame: delivery

  8. Neonatal Hypoglycemia Per Arm

    Time frame: 0-24 h after delivery

  9. Neonatal Hyperbilirubinemia Per Arm

    Time frame: 0-3 days after delivery

  10. Apgar Score at 5 Min After Delivery Per Arm

    Time frame: 5 minutes after delivery

    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

  11. Neonate Transfer to Intensive Care Unit Per Arm

    Time frame: 0-5 days after delivery

  12. Child Outcome at 2 Years Per Arm

    Time frame: 2 years after birth

    neuropsychological and motor skills testing

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
Nov 15, 2010
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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