Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

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

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 Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Drug: Insulin Mixtard; Drug: Metformin

Detailed Description

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:

1. History taking:

2. General and Abdominal Examination:

   With particular emphasis on :

   • Body mass index
   • Blood pressure.
   • Fundal height .
   • Estimated fetal weight .

3. 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.

4. Investigations:

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

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

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: oral metformin and insulin; Intervention 'Insulin Mixtard' and Intervention 'metformin' had included	Drug: 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.; Other Names: insulin mixtures; Drug: 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.; Other Names: Metformin Hydrocloride
ACTIVE_COMPARATOR: insulin therapy only; Intervention 'Insulin Mixtard' had included	Drug: 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.; Other Names: insulin mixtures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Glycemic Control Over Period 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	from 20 weeks to 36 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Macrosomic Baby	Fetal macrosomia has been defined birth weight greater than 4500 gm	24 hours after delivery
Number of Participants With Neonates Who Were Hypoglycemic	Neonatal hypoglycemia defined as a plasma glucose level of less than 30 mg/dL in the first 24 hours after delivery	24 hours after delivery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: March 28, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Metformin; Insulin, pork; isophane insulin, pork drug combination 30:70
• Other Study ID Numbers: METFORMIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO