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Metformin Versus Insulin in Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT01240785
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Tapani Rönnemaa, Turku University Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Gestational Diabetes Drug: metformin Drug: insulin Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.
Study Start Date : June 2006
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Metformin
Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values
 Drug: metformin
metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
Other Name: Diformin retard 500 mg
Active Comparator: insulin
NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values
 Drug: insulin
subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
Other Names:
  • Protaphane
  • Humalog


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240785


Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Tapani Rönnemaa, MD, PhD Professor, Chief Physician
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tapani Rönnemaa, professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01240785    
Other Study ID Numbers: 246/2005
First Posted: November 15, 2010    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014
Last Verified: November 2014
Keywords provided by Tapani Rönnemaa, Turku University Hospital:
gestational diabetes
metformin
insulin
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pregnancy Complications
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs