Trial · NCT03106870
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
NCT03106870, Not applicable, Completed, Ain Shams University; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus. Trials, record NCT03106870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03106870
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
- NCT number
- NCT03106870
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 62 participants, actual
- Lead sponsor
- Ain Shams University
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Interventions
- Insulin Mixtard, Metformin
- First posted
- 2017-04-11
- Last updated
- 2017-06-14
- Results first posted
- 2017-06-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | from 20 weeks to 36 weeks gestation | Fasting and two-hours postprandial blood glucose every 48 hours, till reaching the target blood glucose concentrations: 60 - 95 mg/dl and \< 120 mg/dl (for fasting and two-hour postprandial status, respectively) If patient reached blood glucose concentrations, she considered as controlled Diabetes Mellitus If patient did not reach blood glucose concentrations, she considered as uncontrolled Diabetes Mellitus |
| Secondary | Number of Participants With a Macrosomic Baby | 24 hours after delivery | Fetal macrosomia has been defined birth weight greater than 4500 gm |
| Secondary | Number of Participants With Neonates Who Were Hypoglycemic | 24 hours after delivery | Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | from 20 weeks to 36 weeks gestation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Macrosomic Baby | 24 hours after delivery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neonates Who Were Hypoglycemic | 24 hours after delivery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | Oral Metformin and Insulin | 24 | Participants | ||
| Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | Insulin Therapy Only | 27 | Participants | ||
| Number of Participants With a Macrosomic Baby | Oral Metformin and Insulin | 5 | Participants | ||
| Number of Participants With a Macrosomic Baby | Insulin Therapy Only | 12 | Participants | ||
| Number of Participants With Neonates Who Were Hypoglycemic | Oral Metformin and Insulin | 5 | Participants | ||
| Number of Participants With Neonates Who Were Hypoglycemic | Insulin Therapy Only | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Metformin and Insulin | 31 | |
| Overall Study | STARTED | Insulin Therapy Only | 31 | |
| Overall Study | COMPLETED | Oral Metformin and Insulin | 31 | |
| Overall Study | COMPLETED | Insulin Therapy Only | 31 | |
| Overall Study | NOT COMPLETED | Oral Metformin and Insulin | 0 | |
| Overall Study | NOT COMPLETED | Insulin Therapy Only | 0 |
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 | Oral Metformin and Insulin | ||
| Total, all-cause mortality | Insulin Therapy Only | ||
| Total, other adverse events | Oral Metformin and Insulin | 0 | 31 |
| Total, other adverse events | Insulin Therapy Only | 0 | 31 |
| Total, serious adverse events | Oral Metformin and Insulin | 0 | 31 |
| Total, serious adverse events | Insulin Therapy Only | 0 | 31 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Metformin and Insulin vs Insulin Therapy Only: Number of Participants With a Macrosomic Baby | Trial comparisons |
| Oral Metformin and Insulin vs Insulin Therapy Only: Number of Participants With Neonates Who Were Hypoglycemic | Trial comparisons |
| Oral Metformin and Insulin vs Insulin Therapy Only: Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation | Trial comparisons |
| Oral Metformin and Insulin vs Insulin Therapy Only: 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/NCT03106870
GET https://conductscience.org/api/trials/v1/NCT03106870/registered