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Completed

NCT Number: NCT03106870

Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

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

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.

All patients were subjected to:

  • History taking:
  • General and Abdominal Examination:

With particular emphasis on :

  • Body mass index
  • Blood pressure.
  • Fundal height .
  • Estimated fetal weight .
  • Insulin and metformin doses :

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 dose :

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.

  • Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

  • Group I: pregnant women who received oral metformin in addition to insulin therapy.
  • Group II: pregnant women who received insulin therapy only.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20 - 35 years.
  • Gestational age: 20- 36 weeks gestation.
  • Singleton pregnancy.
  • Women with pregestational or gestational diabetes mellitus

Exclusion criteria

  • Pregnant women with secondary diabetes (e.g. those on chronic steroid therapy).
  • Hypertensive patients.
  • Women with impaired liver or renal function
  • Non-compliant patients.

Treatment and study plan

Insulin Mixtard

Drug

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.

Other names: insulin mixtures

metformin

Drug

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.

Other names: Metformin Hydrocloride

Primary outcomes

  1. Number of Participants With Glycemic Control Over Period From 20 Weeks to 36 Weeks Gestation

    Time frame: 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 outcomes

  1. Number of Participants With a Macrosomic Baby

    Time frame: 24 hours after delivery

    Fetal macrosomia has been defined birth weight greater than 4500 gm

  2. Number of Participants With Neonates Who Were Hypoglycemic

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2017
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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