At a glance

ClinicalIndex Comparison Record

N/ACompleted· 62 enrolled

Drug / intervention

Insulin Mixtard +1 moredrug

Likely dose

Insulin Mixtard 0.7 IUfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03106870

NCT03106870N/ACompleted

Compare CT.gov

Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus and Improving Neonatal Outcome Regarding Birth Weight

Ain Shams University·interventional·Posted Apr 11, 2017·Updated Jun 14, 2017

In Brief

A clinical study evaluating Insulin Mixtard and Metformin for Gestational Diabetes Mellitus in Pregnancy. Completed, enrolled 62 participants.

Detailed Summary

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGestational Diabetes Mellitus in Pregnancy

Countries--

Collaborators--

Timeline

N/ACompletedFinished

2017201820192020202120222023202420252026

Enrollment StartJun 2016

Primary CompletionDec 2016

First PostedApr 2017

TodayJul 2026

First PostedApr 11, 2017

Enrollment StartJun 1, 2016

Primary CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 9.2 years ago

Interventions

Insulin Mixtarddrug

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.

Metformindrug

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.