Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01087866
First received: March 15, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in gestational diabetes mellitus to the same extent as insulin therapy.


Condition Intervention Phase
Gestational Diabetes Mellitus
Drug: Metformin
Drug: Insulin
Phase 2
Phase 3

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 the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Percentage of fetal macrosomy

Enrollment: 97
Study Start Date: June 2005
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin Drug: Metformin
Active Comparator: Insulin Drug: Insulin

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • gestational diabetes mellitus diagnosed between 12-34 pregnancy weeks if normoglycemia is not reached with diet

Exclusion Criteria:

  • hypertension with pharmacological treatment or preeclampsia
  • multiple pregnancy
  • liver or kidney disease
  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: NCT01087866

Locations
Finland
Oulu University Hospital
Oulu, Finland, 90029
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Hilkka Ijas, MD Oulu University Hospital
Study Director: Tytti Raudaskoski, MD,PhD Oulu University Hospital
Study Chair: Marja Vaarasmaki, MD, PhD Oulu University Hospital
  More Information

No publications provided by University of Oulu

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ijas Hilkka, MD, Dept. Obstetrics and Gynecology, Oulu University Hospital
ClinicalTrials.gov Identifier: NCT01087866     History of Changes
Other Study ID Numbers: 070471
Study First Received: March 15, 2010
Last Updated: March 15, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
Gestational diabetes mellitus
treatment
metformin

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

ClinicalTrials.gov processed this record on October 01, 2014