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

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 221
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
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

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Turku University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: December 4, 2013
Last Updated: November 21, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
gestational diabetes
metformin
insulin

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

ClinicalTrials.gov processed this record on November 25, 2014