The effect of Metformin in women with Type 2 diabetes during pregnancy

Not Applicable

Completed

• Conditions: Type 2 diabetes mellitus; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN00928792
• Lead Sponsor: The Centre for Mother, Infant, and Child Research (CMICR) (Canada)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32946820/ (added 29/01/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-26
• Study Completion: 2019-12-31
• Last Update Posted: 8 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 502

Inclusion Criteria

1. Women between the ages of 18-45
2. Women diagnosed with type 2 diabetes prior to pregnancy or women with undiagnosed type 2 diabetes diagnosed prior to 20 weeks gestation [defined as women presenting with gestational diabetes before 20 weeks gestation with an elevated glycosylated hemoglobin (HbA1c) which is 8% or more above the upper normal range (i.e. HbA1c of 6.5% if upper normal is 6.0%, or HbA1c 7% if upper normal is 6.5%) or fasting glucose >= 7.0 mmol/L]
3. Pregnancy gestation between 12 weeks 0 days - 22 weeks 6 days
4. Live singleton fetus

Exclusion Criteria

1. Women who are not on insulin
2. Women who are on oral hypoglycemic agents should be switched to insulin prior to randomization
3. Diabetes diagnosed after 20 weeks gestation
4. Type 1 diabetes
5. Known intolerance to metformin
6. Contraindications to metformin use which include:
6.1 Renal insufficiency (defined as serum creatinine of greater than 130 umol/L or creatinine clearance < 60 ml/min
6.2 Moderate to severe liver dysfunction (defined as liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT)) greater than three times the upper limit of normal)
6.3 Shock or sepsis
6.4 Previous hypersensitivity to metformin
7. Women with significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization, or active Crohn's or colitis
8. Previous participation in the trial
9. Patients who have a fetus with a known potentially lethal anomaly will be excluded. Information regarding congenital anomalies diagnosed after randomization will be recorded.
10. Known higher order pregnancies (twins, triplets, etc). These women will be excluded as they have a higher rate of adverse outcomes and we want to avoid any inequalities if they are unequally distributed between the groups
11. Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis
12. History of diabetic ketoacidosis or history of lactic acidosis
13. Presence of excessive alcohol intake, acute or chronic
14. Presence of congestive heart failure or history of congestive heart failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified