| Trial ID: | L2723 |
| Source ID: | NCT00678080
|
| Associated Drug: |
Metformin
|
| Title: |
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00678080/results
|
| Conditions: |
Pregnancy Complications
|
| Interventions: |
DRUG: Metformin|DRUG: Insulin (NPH and Regular)
|
| Outcome Measures: |
Primary: The Number of Participants Who Achieved a Hemoglobin A1C <7%, The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes., during third trimester|The Number of Participants Who Achieved a Hemoglobin A1C <7%, The hemoglobin A1c level is an indicator of glycemic control-it indicates the average level of blood sugar over the past 2 to 3 months. Hemoglobin A1c levels 6.5% and higher indicate diabetes., at the time of delivery | Secondary: Body Mass Index, at the time of delivery|Number of Participants With Hypoglycemia, Defined as hypoglycemia as documented by neonatal chart based on health care provider description, During pregnancy|Number of Participants Who Failed Metformin Therapy, Those whose glucose levels were above target range thereby needing insulin therapy, Duration of pregnancy|Number of Participants Who Had a Cesarean Section, At the time of delivery|Number of Participants With Fetus With Macrosomia, At the time of delivery|Number of Participants With Shoulder Dystocia, At the time of delivery|Number of Participants Who Had a Newborn With Respiratory Distress Syndrome, Neonatal period|Number of Participants With Newborns Who Needed Neonatal Dextrose, Neonatal period
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center, Houston
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
|
| Enrollment: |
25
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-09
|
| Completion Date: |
2011-08
|
| Results First Posted: |
2018-11-28
|
| Last Update Posted: |
2018-11-28
|
| Locations: |
Valley Baptist Hospital, Brownsville, Texas, 78520, United States|Lyndon B Johnson Hospital, Houston, Texas, 77026, United States|Memorial Hermann Hospital, Houston, Texas, 77030, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00678080
|
