Trial · NCT03380546
Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
NCT03380546, Phase 3, Terminated, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus. Trials, record NCT03380546. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03380546
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acarbose and Prandial Insulin for the Treatment of Gestational Diabetes Mellitus.
- NCT number
- NCT03380546
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 341 participants, actual
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- Gestational Diabetes Mellitus in Pregnancy
- Interventions
- Acarbose, Prandial insulin
- First posted
- 2017-12-21
- Last updated
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite endpoint: birth weight ≥ 90th percentile for gestational age (large for gestational age: LGA) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth injury. | At delivery | LGA defined as birth weight greater than the 90th percentile for a standard French population * Neonatal hypoglycemia defined as at least a blood glucose value less than a 2.0 mmol/l during the two first days of life; * Shoulder dystocia, defined as vaginal cephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed. We will only consider rotational maneuvers such as Rubin II or Woods corkscrew or Jaquemier maneuvers * Birth injury defined as plexus injury or clavicle fracture. |
| Secondary | GLUCOSE CONTROL: Capillary glucose levels | From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery | The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary. |
| Secondary | GLUCOSE CONTROL: HbA1c | At delivery | Centralized measurement |
| Secondary | GLUCOSE CONTROL: Need for and dose/day of basal and prandial insulin in both arms | At delivery | This information will be retrieved from the glucose meter, and if not available, from the woman's diary. |
| Secondary | Neonatal complications : Birth weight and height, | At delivery | Birth weight ≥ 4000g Birth weight ≥ 4500g |
| Secondary | Neonatal complications : Small for gestational age infant | At delivery | SGA: birth weight lower than the 10th percentile for a standard French population |
| Secondary | Maternal complications : Preeclampsia | From two weeks after inclusion to delivery | Preeclampsia (blood pressure ≥ 140/90 mmHg on two measurements four hours apart and proteinuria of at least 300 mg/24 hours or 3+ or more on dipstick testing or proteinuria/creatininuria \>30 in a random urine sample). |
| Secondary | Maternal complications : Pregnancy-induced hypertension | From two weeks after inclusion : 14 and 37 (+6 days) weeks of amenorrhea to delivery | In women with no known hypertension before pregnancy, blood pressure ≥ 140/90 mmHg on two measurements four hours apart without proteinuria and having needed to begin anti-hypertensive therapy |
| Secondary | Neonatal complications : Preterm delivery | At delivery | * Late preterm infant (between 32 and 37 completed weeks' gestation) * Very preterm infant (28-31 completed weeks' gestation) * Extreme preterm infant (less than 28 completed weeks' gestation) |
| Secondary | Neonatal complications : Low Apgar score | At delivery | 5-min Apgar score \< 7 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
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.
Papers4
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/NCT03380546
GET https://conductscience.org/api/trials/v1/NCT03380546/registered