Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT01087866 |
Recruitment Status :
Completed
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gestational Diabetes Mellitus | Drug: Metformin Drug: Insulin | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 97 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | October 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Metformin |
Drug: Metformin |
Active Comparator: Insulin |
Drug: Insulin |
- Percentage of fetal macrosomy

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
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

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): NCT01087866
Finland | |
Oulu University Hospital | |
Oulu, Finland, 90029 |
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 |
Responsible Party: | Ijas Hilkka, MD, Dept. Obstetrics and Gynecology, Oulu University Hospital |
ClinicalTrials.gov Identifier: | NCT01087866 |
Other Study ID Numbers: |
070471 |
First Posted: | March 16, 2010 Key Record Dates |
Last Update Posted: | March 16, 2010 |
Last Verified: | March 2010 |
Gestational diabetes mellitus treatment metformin |
Diabetes, Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Pregnancy Complications Metformin Hypoglycemic Agents Physiological Effects of Drugs |