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Comparison · NCT03106870-dab816d8

Oral Metformin and Insulin vs Insulin Therapy Only: Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. 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, record NCT03106870-dab816d8. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03106870-dab816d8

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7740.6020.886wilson
Risk in group 20.8710.7110.949wilson
Risk difference, group 1 minus group 2-0.0968-0.2860.098newcombe hybrid score
Risk ratio, group 1 over group 20.8890.7041.12log
Odds ratio, group 1 over group 20.5080.1321.95log
Number needed to treat, for one fewer participant with the outcome on Oral Metformin and Insulin than on Insulin Therapy Only10.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Oral Metformin and Insulin
Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~* 0.7 IU/Kg (at the second trimester of pregnancy).~* 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
2431OG000
Group 2Insulin Therapy Only
Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~* 0.7 IU/Kg (at the second trimester of pregnancy).~* 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.
2731OG001

Outcome

Type
PRIMARY
Title
Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation
Description
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
Time frame
from 20 weeks to 36 weeks gestation
Population

Source ClinicalTrials.gov

Trial

Title
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
NCT number
NCT03106870
Phases
NA
Conditions
Gestational Diabetes Mellitus in Pregnancy
Interventions
Insulin Mixtard, Metformin
Lead sponsor
Ain Shams University
Results first posted
2017-06-14

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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