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Metformin Versus Insulin in Gestational Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tapani Rönnemaa, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01240785
First received: November 3, 2010
Last updated: November 21, 2014
Last verified: November 2014

November 3, 2010
November 21, 2014
June 2006
January 2011   (final data collection date for primary outcome measure)
Birth Weight Per Arm [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
birth weight adjusted for gestational weeks expressed as standard deviation units using data from Finnish fetal growth charts in normal pregnancies
birth weight
birth weight adjusted for gestational weeks
Complete list of historical versions of study NCT01240785 on ClinicalTrials.gov Archive Site
  • Pregnancy Induced Hypertension Per Arm [ Time Frame: up to on the average 40 weeks of gestation ] [ Designated as safety issue: Yes ]
    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
  • Maternal Weight Gain Per Arm [ Time Frame: up to on the average 40 weeks of gestation ] [ Designated as safety issue: No ]
  • Pre-eclampsia Per Arm [ Time Frame: up to on the average 40 weeks of gestation ] [ Designated as safety issue: Yes ]
  • Mode of Delivery Per Arm [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Gestational Weeks at Delivery Per Arm [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  • Induction of Delivery Per Arm [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Shoulder Dystocia Per Arm [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  • Neonatal Hypoglycemia Per Arm [ Time Frame: 0-24 h after delivery ] [ Designated as safety issue: Yes ]
  • Neonatal Hyperbilirubinemia Per Arm [ Time Frame: 0-3 days after delivery ] [ Designated as safety issue: Yes ]
  • Apgar Score at 5 Min After Delivery Per Arm [ Time Frame: 5 minutes after delivery ] [ Designated as safety issue: Yes ]
    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
  • Neonate Transfer to Intensive Care Unit Per Arm [ Time Frame: 0-5 days after delivery ] [ Designated as safety issue: Yes ]
  • Child Outcome at 2 Years Per Arm [ Time Frame: 2 years after birth ] [ Designated as safety issue: Yes ]
    neuropsychological and motor skills testing
  • pregnancy induced hypertension [ Time Frame: up to on the average 40 weeks of gestation ] [ Designated as safety issue: Yes ]
  • maternal weight gain [ Time Frame: up to on the average 40 weeks of gestation ] [ Designated as safety issue: No ]
  • pre-eclampsia [ Time Frame: up to on the average 40 weeks of gestation ] [ Designated as safety issue: Yes ]
  • mode of delivery [ Designated as safety issue: No ]
  • gestational weeks at delivery [ Designated as safety issue: Yes ]
  • induction of delivery [ Designated as safety issue: No ]
  • shoulder dystocia [ Designated as safety issue: Yes ]
  • neonatal hypoglycemia [ Designated as safety issue: Yes ]
  • neonatal hyperbilirubinemia [ Designated as safety issue: Yes ]
  • Apgar score at 5 min after delivery [ Designated as safety issue: Yes ]
  • neonate transfer to intensive care unit [ Designated as safety issue: Yes ]
  • child outcome at 2 years [ Designated as safety issue: Yes ]
    neuropsychological and motor skills testing
Not Provided
Not Provided
 
Metformin Versus Insulin in Gestational Diabetes
Metformin Versus Insulin in Gestational Diabetes. A Randomized Controlled Single Center Trial.

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gestational Diabetes
  • Drug: metformin
    metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
    Other Name: Diformin retard 500 mg
  • 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
  • Active Comparator: Metformin
    Metformin 500 mg 1-2 tablets twice daily according to plasma glucose values
    Intervention: Drug: metformin
  • Active Comparator: insulin
    NPH insulin once or twice daily and/or insulin lispro or aspart according to preprandial and postprandial glucose values
    Intervention: Drug: insulin
Tertti K, Laine K, Ekblad U, Rinne V, Rönnemaa 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
December 2012
January 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01240785
246/2005
No
Tapani Rönnemaa, Turku University Hospital
Turku University Hospital
Not Provided
Principal Investigator: Tapani Rönnemaa, MD, PhD Professor, Chief Physician
Turku University Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP