Trial · NCT00835861

Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes

NCT00835861, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2014-05-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes. Trials, record NCT00835861. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00835861

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness of Metformin Compared to Insulin in Pregnant Women With Mild Preexisting or Early Gestational Diabetes
NCT number: NCT00835861
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Non Insulin Dependent Diabetes, Pregnancy
Interventions: Metformin, Insulin
First posted: 2009-02-04
Last updated: 2017-04-25
Results first posted: 2014-05-26
Limitations and caveats: Unable to achieve enrollment goal before funding period expired because recruitment progressed more slowly than anticipated.

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Blood Glucose Measurements	Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery	Patients self monitored glucose measures throughout pregnancy to aid glycemic control. Fasting morning measures and postprandial measures were taken at 1 hour after breakfast, lunch, and dinner.
Secondary	Number of Patients With Obstetric Complications	Throughout pregnancy until hospital discharge following delivery.	Maternal complications were stillbirths, major malformations, shoulder dystocia, or postpartum hemorrhage requiring transfusion.
Secondary	Maternal Weight Gain	Baseline throughout pregnancy until last prenatal visit.
Secondary	Number of Babies With Neonatal Hypoglycemia	Time of delivery through hospital discharge	Initial neonatal glucose \< 40 mg/dL
Secondary	Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester	1st, 2nd, and 3rd trimester
Secondary	Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)	Baseline throughout pregnancy until time of delivery	NUMBER OF ASSESSMENTS OF FASTING GLUCOSE VALUES \<95
Secondary	Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)	Baseline throughout pregnancy until time of delivery	NUMBER OF ASSESSMENTS OF POSTPRANDIAL GLUCOSE VALUES \<130
Secondary	Number of Episodes Maternal Hypoglycemia	Baseline throughout pregnancy until time of delivery	Maternal glucose \< 60 mg/dL
Secondary	Number of Babies With Adverse Neonatal Outcomes	Delivery until hospital discharge	Resuscitation in the delivery room, preterm birth \< 37 weeks, neonatal intensive care unit care, birth injury or diagnosis of neonatal complication, glucose infusion, antibiotics, or phototherapy.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Blood Glucose Measurements	Daily fasting and 1-hr post prandial measures were taken from time of enrollment until delivery	For 1 infant in each group, the initial neonatal glucose value was missing.	mg/dL	MEDIAN
SECONDARY	Number of Patients With Obstetric Complications	Throughout pregnancy until hospital discharge following delivery.		participants	NUMBER
SECONDARY	Maternal Weight Gain	Baseline throughout pregnancy until last prenatal visit.		kg/week	MEDIAN
SECONDARY	Number of Babies With Neonatal Hypoglycemia	Time of delivery through hospital discharge	For 1 infant in each group, the initial neonatal glucose value was missing.	Number of babies	NUMBER
SECONDARY	Glycosylated Hemoglobin (HbA1c) by Pregnancy Trimester	1st, 2nd, and 3rd trimester		percentage of glycosolated hemoglobin	MEDIAN
SECONDARY	Percent of Glucose Values at or Below Fasting Goal (<95 mg/dL)	Baseline throughout pregnancy until time of delivery		percent of glucose values	NUMBER
SECONDARY	Percent of Glucose Values at or Below Postprandial Goal (<130 mg/dL)	Baseline throughout pregnancy until time of delivery		percent of glucose values	NUMBER
SECONDARY	Number of Episodes Maternal Hypoglycemia	Baseline throughout pregnancy until time of delivery		Number of episodes	NUMBER
SECONDARY	Number of Babies With Adverse Neonatal Outcomes	Delivery until hospital discharge	For 1 infant in the metformin group, the adverse neonatal outcome data was missing.	number of babies	NUMBER

Source ClinicalTrials.gov

Results by group48

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Blood Glucose Measurements	Metformin	Fasting throughout enrollment	97.38	Inter-Quartile Range 92 to 101	mg/dL
Blood Glucose Measurements	Insulin	Fasting throughout enrollment	95.04	Inter-Quartile Range 86 to 115	mg/dL
Blood Glucose Measurements	Metformin	Fasting 18-20 weeks	97.00	Inter-Quartile Range 93 to 100	mg/dL
Blood Glucose Measurements	Insulin	Fasting 18-20 weeks	92.38	Inter-Quartile Range 89 to 116	mg/dL
Blood Glucose Measurements	Metformin	Fasting 28-30 weeks	92.43	Inter-Quartile Range 90 to 98	mg/dL
Blood Glucose Measurements	Insulin	Fasting 28-30 weeks	90.64	Inter-Quartile Range 84 to 106	mg/dL
Blood Glucose Measurements	Metformin	Fasting 36-38 weeks	89.49	Inter-Quartile Range 82 to 96	mg/dL
Blood Glucose Measurements	Insulin	Fasting 36-38 weeks	85.18	Inter-Quartile Range 80 to 107	mg/dL
Blood Glucose Measurements	Metformin	Postprandial throughout enrollment	120.40	Inter-Quartile Range 115 to 129	mg/dL
Blood Glucose Measurements	Insulin	Postprandial throughout enrollment	128.62	Inter-Quartile Range 115 to 143	mg/dL

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metformin	15
Overall Study	STARTED	Insulin	16
Overall Study	COMPLETED	Metformin	14
Overall Study	COMPLETED	Insulin	14
Overall Study	NOT COMPLETED	Metformin	1
Overall Study	NOT COMPLETED	Insulin	2

Source ClinicalTrials.gov

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Intrauterine fetal demise	Pregnancy, puerperium and perinatal conditions	Metformin	1	14	1
serious	Intrauterine fetal demise	Pregnancy, puerperium and perinatal conditions	Insulin	0	14	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metformin
Total, all-cause mortality	Insulin
Total, other adverse events	Metformin	0	14
Total, other adverse events	Insulin	0	14
Total, serious adverse events	Metformin	1	14
Total, serious adverse events	Insulin	0	14

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23096052	DERIVED

Source PubMed

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 comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Metformin vs Insulin: Number of Patients With Obstetric Complications	Trial comparisons
Metformin vs Insulin: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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