Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus
Overview[ - collapse ][ - ]
| 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 | Gestational Diabetes Mellitus |
| Intervention | Drug: Metformin Drug: Insulin |
| Phase | Phase 2/Phase 3 |
| Sponsor | University of Oulu |
| Responsible Party | University of Oulu |
| ClinicalTrials.gov Identifier | NCT01087866 |
| First Received | March 15, 2010 |
| Last Updated | March 15, 2010 |
| Last verified | March 2010 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 15, 2010 |
|---|---|
| Last Updated Date | March 15, 2010 |
| Start Date | June 2005 |
| Estimated Primary Completion Date | October 2009 |
| Current Primary Outcome Measures | Percentage of fetal macrosomy |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus |
|---|---|
| Official Title | Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gestational Diabetes Mellitus |
| Intervention | Drug: Metformin Drug: Insulin |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 97 |
| Estimated Completion Date | October 2009 |
| Estimated Primary Completion Date | August 2009 |
| Eligibility 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Not Provided |
| Contacts | Not Provided |
| Location Countries | Finland |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01087866 |
|---|---|
| Other Study ID Numbers | 070471 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Oulu |
| Study Sponsor | University of Oulu |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Hilkka Ijas, MD Oulu University HospitalStudy Director: Tytti Raudaskoski, MD,PhD Oulu University HospitalStudy Chair: Marja Vaarasmaki, MD, PhD Oulu University Hospital |
| Verification Date | March 2010 |
Locations[ + expand ][ + ]
| Oulu University Hospital | Oulu, Finland, 90029 |
|---|