Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.

NCT03928340 | Completed Phase 4 DMC

• 1 other identifier: FMBSUREC/05032019/Abd Alaziz
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• HbA1c

  the change in level of glycosylated haemoglobin

  12 weeks

• capillary glucose

  the change in level of glucose in capillary blood

  12 weeks

• fasting blood sugar measurement.

  the change in level of glucose in venous blood after fasting for 8 hours

  12 weeks

• 2 hours post prandial blood sugar measurement.

  the change in level of glucose in venous blood 2 hours after meal

  12 weeks

Secondary Outcomes (10)

• Maternal weight gain

  12 weeks

• weekly fetal weight gain measured by ultrasound

  12 weeks

• insulin requirements

  12 weeks

• attacks of maternal hypoglycemia

  12 weeks

• intra uterine fetal death (IUFD)

  12 weeks

Study Arms (2)

combined metformin and insulin

ACTIVE COMPARATOR

Drug: Metformin; Drug: Insulin

Insulin only

OTHER

Drug: Insulin

Interventions

Metformin DRUG

40 patients will be treated with metformin (1 gm twice daily (with the 2 main meals)), combined with insulin therapy

combined metformin and insulin

Insulin DRUG

40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)

Insulin only; combined metformin and insulin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diabetic pregnant patients with type one diabetes and no other chronic disorders
• Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start of gestation)
• Patients pregnant in single living fetus with no apparent congenital anomalies
• Haemoglobin A 1 C (HbA1c) level between 7% to 11%
• All patients have done a dating ultrasound to confirm gestational age, viability and rule out any abnormality

You may not qualify if:

• Patients with type 2 or gestational diabetes
• Patients with intolerance or hypersensitivity to metformin
• Patients with congestive heart failure or a history of congestive heart failure
• Patients with renal insufficiency
• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead
• Amal Kotb Abdallah: collaborator
• Amir Gabr: collaborator
• Mohamed Abdeltawwab Mahmoud: collaborator

Study Sites (1)

Beniswef university hospital

Cairo, Egypt

Location

MeSH Terms

Interventions

Metformin; Insulin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amal kotb

  Beniswef university hospital

  PRINCIPAL INVESTIGATOR

• Amir Gabr

  Cairo university kasrelainy hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 20, 2019
• First Posted: April 26, 2019
• Study Start: April 29, 2019
• Primary Completion: March 29, 2020
• Study Completion: March 29, 2020
• Last Updated: May 28, 2020

Record last verified: 2020-05

Locations

EG (1)