Trial · NCT01329016
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
NCT01329016, Phase 1, Phase 2, Completed, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glyburide and Metformin for Gestational Diabetes Mellitus (GDM). Trials, record NCT01329016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01329016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)
- NCT number
- NCT01329016
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 177 participants, actual
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Conditions
- Gestational Diabetes Mellitus
- Interventions
- Glyburide, Metformin, Glyburide-Metformin combination
- First posted
- 2011-04-05
- Last updated
- 2026-05-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study drug dosage in pregnancy | Completion of data collection (4-5mnths on average in GDM and healthy pregnant women and max of 6 months in newly diagnosed T2DMs) | (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. |
| Secondary | Determine GLY and MET PK parameters | Conclusion of data collection (up to 6 months) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01329016
GET https://conductscience.org/api/trials/v1/NCT01329016/registered