Trial · NCT00678080
Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
NCT00678080, Not applicable, Completed, The University of Texas Health Science Center, Houston; results first posted 2018-11-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes. Trials, record NCT00678080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00678080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin Versus Insulin in Pregnant Women With Type 2 Diabetes
- NCT number
- NCT00678080
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 25 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Pregnancy Complications
- Interventions
- Metformin, Insulin (NPH and Regular)
- First posted
- 2008-05-15
- Last updated
- 2018-11-28
- Results first posted
- 2018-11-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants Who Achieved a Hemoglobin A1C <7% | during third trimester | 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. |
| Primary | The Number of Participants Who Achieved a Hemoglobin A1C <7% | at the time of delivery | 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. |
| Secondary | Body Mass Index | at the time of delivery | |
| Secondary | Number of Participants With Hypoglycemia | During pregnancy | Defined as hypoglycemia as documented by neonatal chart based on health care provider description |
| Secondary | Number of Participants Who Failed Metformin Therapy | Duration of pregnancy | Those whose glucose levels were above target range thereby needing insulin therapy |
| Secondary | Number of Participants Who Had a Cesarean Section | At the time of delivery | |
| Secondary | Number of Participants With Fetus With Macrosomia | At the time of delivery | |
| Secondary | Number of Participants With Shoulder Dystocia | At the time of delivery | |
| Secondary | Number of Participants Who Had a Newborn With Respiratory Distress Syndrome | Neonatal period | |
| Secondary | Number of Participants With Newborns Who Needed Neonatal Dextrose | Neonatal period |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants Who Achieved a Hemoglobin A1C <7% | during third trimester | During the third trimester, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 12 in the insulin arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Body Mass Index | at the time of delivery | kg/m^2 | MEAN | |
| SECONDARY | Number of Participants With Hypoglycemia | During pregnancy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Failed Metformin Therapy | Duration of pregnancy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Had a Cesarean Section | At the time of delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Fetus With Macrosomia | At the time of delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Shoulder Dystocia | At the time of delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Had a Newborn With Respiratory Distress Syndrome | Neonatal period | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Newborns Who Needed Neonatal Dextrose | Neonatal period | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | The Number of Participants Who Achieved a Hemoglobin A1C <7% | at the time of delivery | At the time of delivery, hemoglobin A1c levels were obtained for only 5 in the metformin arm and 8 in the insulin arm. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants Who Achieved a Hemoglobin A1C <7% | Metformin | 5 | Participants | ||
| The Number of Participants Who Achieved a Hemoglobin A1C <7% | Insulin | 12 | Participants | ||
| Body Mass Index | Metformin | 35.9 | Standard Deviation 5.2 | kg/m^2 | |
| Body Mass Index | Insulin | 40.1 | Standard Deviation 8.4 | kg/m^2 | |
| Number of Participants With Hypoglycemia | Metformin | 0 | Participants | ||
| Number of Participants With Hypoglycemia | Insulin | 0 | Participants | ||
| Number of Participants Who Failed Metformin Therapy | Metformin | 0 | Participants | ||
| Number of Participants Who Had a Cesarean Section | Metformin | 4 | Participants | ||
| Number of Participants Who Had a Cesarean Section | Insulin | 6 | Participants | ||
| Number of Participants With Fetus With Macrosomia | Metformin | 0 | Participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 11 | |
| Overall Study | STARTED | Insulin | 14 | |
| Overall Study | COMPLETED | Metformin | 8 | |
| Overall Study | COMPLETED | Insulin | 13 | |
| Overall Study | NOT COMPLETED | Metformin | 3 | |
| Overall Study | NOT COMPLETED | Insulin | 1 |
Source ClinicalTrials.gov
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 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 | 8 |
| Total, other adverse events | Insulin | 0 | 13 |
| Total, serious adverse events | Metformin | 0 | 8 |
| Total, serious adverse events | Insulin | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Metformin vs Insulin: The Number of Participants Who Achieved a Hemoglobin A1C <7% | Trial comparisons |
| Metformin vs Insulin: Number of Participants With Shoulder Dystocia | Trial comparisons |
| Metformin vs Insulin: Number of Participants With Fetus With Macrosomia | Trial comparisons |
| Metformin vs Insulin: Number of Participants With Hypoglycemia | Trial comparisons |
| Metformin vs Insulin: Number of Participants With Newborns Who Needed Neonatal Dextrose | Trial comparisons |
| Metformin vs Insulin: Number of Participants Who Had a Newborn With Respiratory Distress Syndrome | Trial comparisons |
| Metformin vs Insulin: Number of Participants Who Had a Cesarean Section | Trial comparisons |
| Metformin vs Insulin: The Number of Participants Who Achieved a Hemoglobin A1C <7% | 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.
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/NCT00678080
GET https://conductscience.org/api/trials/v1/NCT00678080/registered