Maternal Weight Gain in Gestational Diabetes Controlled by Metformin Versus Insulin

NCT03841591 | Completed Phase 3

• 1 other identifier: MatWt-GDM
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Insulin has many disadvantages for mothers with GDM including the need to give injections, frequent daily testing for monitoring, and risks of hypoglycemia, increase in appetite, weight gain and high cost. Metformin, an oral biguanide, may be a more logical alternative to insulin for women with GDM who are unable to cope with the increasing insulin resistance of pregnancy. This study aim to compare maternal weight gain during pregnancy in women with gestational diabetes, treated by insulin versus metformin.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of maternal weight gain per week

  Maternal weight (in grams) will be measured monthly. Difference in measured weight between starting treatment and delivery will be divided by the number of weeks.

  4 months

Secondary Outcomes (5)

• 1-min APGAR score

  1 minute

• 5-min APGAR score

  5 minutes

• Incidence of neonatal hypoglycemia

  1 day

• Incidence of neonatal respiratory distress

  1 day

• Incidence of macrosomia

  1 hour

Study Arms (2)

Insulin Group

ACTIVE COMPARATOR

This includes women with GDM allocated to receive insulin treatment. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.

Drug: Insulin; Other: Assessment of weight gain

Metformin Group

ACTIVE COMPARATOR

This includes women with GDM allocated to receive metformin treatment. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.

Drug: Metformin; Other: Assessment of weight gain

Interventions

Insulin DRUG

Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.

Insulin Group

Metformin DRUG

Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.

Also known as: Cidophage

Metformin Group

Assessment of weight gain OTHER

Body weight will be measured monthly from the start of treatment till delivery.

Insulin Group; Metformin Group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged (19-35) years
• BMI 18-30 kg/m2
• Gestational age \>24 weeks
• Singleton pregnancy
• Gestational diabetes mellitus with failure to achieve adequate glucose control on diet therapy alone (FBG \> 105) OR patients with gestational diabetes who are controlled with either metformin alone or insulin alone.

You may not qualify if:

• Pregnant women with preexisting diabetes mellitus
• Women who have contraindication to take metformin e.g.: impaired renal function, hepatic cirrhosis, hepatitis).
• Patients with other medical disorders that could affect perinatal outcome (e.g., hypertension, SLE etc).
• Fetal anomalies identified on ultrasound prior to initiation of therapy.
• Patients who refused to participate

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Insulin; Metformin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Sinaa Hamdy, MBBCh

  S Hamdy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of O&G

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: February 1, 2018
• Primary Completion: December 25, 2018
• Study Completion: January 15, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

EG (1)