| Trial ID: | L3325 |
| Source ID: | NCT01329016
|
| Associated Drug: |
Glyburide
|
| Title: |
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
|
| Acronym: |
GDM
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Gestational Diabetes Mellitus
|
| Interventions: |
DRUG: Glyburide|DRUG: Metformin|DRUG: Glyburide-Metformin combination
|
| Outcome Measures: |
Primary: Study drug dosage in pregnancy, (1) Determination of metformin dosage in pregnancy needed to produce comparable concentrations to the approved dosage range in non-pregnant women. (2)To compare metformin apparent oral clearance in pregnant and non-pregnant women. (3)To evaluate the effect of GLY monotherapy, MET monotherapy, and GLY-MET combination on insulin sensitivity, beta-cell responsivity index and disposition index (response vectors) describing the mechanism and magnitude of effect., Completion of data collection (4-5mnths on average in GDM and healthy pregnant women and max of 6 months in newly diagnosed T2DMs) | Secondary: Determine GLY and MET PK parameters, Determining GLY \& MET PK parameters, including AUC, max concentration, time to max \& min concentrations, oral clearance, half-life, oral volume of distribution, umbilical cord plasma concentrations; correlation between CYP2C9, CYP3A5, BCRP, OATP2B1 genotypes \& GLY PK/PD; GLY \& MET PD parameters, including derived parameters from PK/PD modeling for pregnant \& nonpregnant subjects; duration of initiation of treatment to glycemic control; effects of GDM \& glycemic control on maternal \& umbilical cord EPC cells \& sFLT concentrations; GLY \& MET half-life in neonates; efficacy \& safety data., Conclusion of data collection (up to 6 months)
|
| Sponsor/Collaborators: |
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Collaborators: University of Washington|University of Pittsburgh|University of Texas|Indiana University School of Medicine|RTI International
|
| Gender: |
FEMALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
360
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-07
|
| Completion Date: |
2015-06
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-10
|
| Locations: |
Indiana University School of Medicine, Indianapolis, Indiana, 46202, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|University of Texas Medical Branch, Galveston, Texas, 77555, United States|University of Washington, Seattle, Washington, 98195, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01329016
|
