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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: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention Phase
Gestational Diabetes
 Drug: metformin
Drug: insulin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • birth weight [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
    birth weight adjusted for gestational weeks


Secondary Outcome Measures:
  • 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 [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • gestational weeks at delivery [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  • induction of delivery [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • shoulder dystocia [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
  • neonatal hypoglycemia [ Time Frame: 0-24 h after delivery ] [ Designated as safety issue: Yes ]
  • neonatal hyperbilirubinemia [ Time Frame: 0-3 days after delivery ] [ Designated as safety issue: Yes ]
  • Apgar score at 5 min after delivery [ Time Frame: 5 minutes after delivery ] [ Designated as safety issue: Yes ]
  • neonate transfer to intensive care unit [ Time Frame: 0-5 days after delivery ] [ Designated as safety issue: Yes ]
  • child outcome at 2 years [ Time Frame: 2 years after birth ] [ Designated as safety issue: Yes ]
    neuropsychological and motor skills testing


Enrollment: 230
Study Start Date: June 2006
Study Completion Date: December 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin Drug: metformin
metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
Active Comparator: insulin Drug: insulin
subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery

  Eligibility

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240785

Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Tapani Rönnemaa, MD, PhD Professor, Chief Physician
  More Information

No publications provided

Responsible Party: Tapani Rönnemaa, professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01240785     History of Changes
Other Study ID Numbers: 246/2005
Study First Received: November 3, 2010
Last Updated: December 20, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
gestational diabetes
metformin
insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
 Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013