Effect of Adding Metformin to Insulin in Uncontrolled Diabetic Patients During the 3rd Trimester of Pregnancy

February 17, 2023 updated by: Ayman Hany, MD, Cairo University

Effect of Adding Metformin to Insulin in Uncontrolled Diabetic Patients During the 3rd Trimester of Pregnancy on Glycemic Control, Fetal and Neonatal Outcomes ,Randomized Controlled Trial

Background Diabetes mellitus (DM) is a significant contributor to adverse obstetric and perinatal outcome. There is now clear and unequivocal evidence that adverse pregnancy outcomes are strongly linked to maternal hyperglycemia, both in the peri-conception period and throughout gestation. Although strict glycemic control does improve outcomes, there is still a higher rate of complications in women with DM and poorer perinatal outcomes .

The incidence of type 2 diabetes is rising worldwide at a remarkable rate IDF When receiving large doses of insulin, patients complain of pain at the site of injection leading to compliance issues and poor glycemic control. This can be explained as when taking large doses of insulin it leads to alter absorption kinetics because very large doses are delivered to one site, resulting in a failure to reduce postprandial hyperglycemia, but with later hypoglycemia once the insulin is absorbed. This poor glycemic control in mothers with diabetes leads to an increased risk of severe respiratory distress syndrome, low Apgar scores, neonatal hypoglycemia and neonatal intensive care unit (NICU) admissions .

Infants of mothers with diabetes have high rates of being born large for gestational age (LGA) and macrosomic (>4 or 4.5 kg). Macrosomia is associated with increased rates of perinatal asphyxia, meconium aspiration, hypoglycemia, shoulder dystocia, brachial plexus injury, skeletal injuries, and fetal death .

Metformin is among the oldest and most well studied oral anti hyperglycemic agents. Its efficacy has been demonstrated both in the primary prevention of disease and secondary prevention of diabetes-related morbidity and mortality. Because of metformin's proven efficacy, low cost, and minimal side effect profile, it is largely recommended as the first line, initial monotherapy and as part of any combination therapy (included with insulin) for the treatment and prevention of type II diabetes .

Metformin produces euglycemia by reducing insulin resistance, improving insulin sensitivity, reducing hepatic gluconeogenesis, and increasing peripheral glucose uptake and utilization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives To determine whether the addition of metformin to a standard regimen of insulin is more effective in glycemic control , fetal and neonatal outcome than conventional insulin alone in uncontrolled diabetic patients during the 3rd trimester of pregnancy.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • • Diabetic pregnant patients with single living fetus

    • Patients with gestational or type 2 diabetes
    • Patients on insulin in the 3rd trimester of pregnancy HbA1c level between 7% to 11%
    • All patients require a dating ultrasound to confirm gestational age, viability and rule out multiple.

Exclusion Criteria:

  • Patients with type 1 diabetes

    • Patients with congestive heart failure or a history of congestive heart failure
    • Patients with renal insufficiency
    • Patients with intolerance or hypersensitivity to metformin
    • Patients having current significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization
    • Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a history of diabetic ketoacidosis or history of lactic acidosis
    • Patients with liver impairment
    • Patients with known higher order pregnancies (twins, triplets, etc.)
    • Patients having a known potentially fetal lethal anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin Group
will include 75 patients who will be treated with metformin ( 1gm with the 2 main meals ) combined with insulin therapy
Drug: Metformin
1gm tablet with the 2 main meals
Drug: Insulin
subcutaneous insulin daily administration
Experimental: Insulin alone group
will include 75 patients who will be treated with insulin alone
Drug: Insulin
subcutaneous insulin daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal glycemic control 3 months.
Time Frame: 3 months
blood glucose levels
3 months
Maternal insulin requirements
Time Frame: 3 months
Daily Insulin doses requirements
3 months
Maternal Blood glucose readings
Time Frame: 3 months
fasting and 2 hours post prandial blood sugar.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal weight gain
Time Frame: 3 months
measured by kilograms
3 months
weekly fetal weight gain
Time Frame: 3 months
measured by ultrasound in grams
3 months
increase of attacks of maternal hypoglycemia.
Time Frame: 3 months
maternal hypoglycemia defined by plasma glucose level below 65 mg/dl
3 months
fetal outcomes
Time Frame: 3 months
intra uterine fetal death (IUFD)
3 months
Neonatal outcomes
Time Frame: 1 week
RDS
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • reda-metformin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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