Metformin in mild gestational diabetes mellitus: a double-blind placebo-controlled randomised trial

Not Applicable

Completed

• Conditions: Mild gestational diabetes mellitus; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN10845466
• Lead Sponsor: niversity Malaya Medical Centre

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/33890319/ (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-07
• Study Completion: 2019-01-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 106

Inclusion Criteria

Current inclusion criteria as of 11/12/2017:
1. Aged 18 to 45 years
2. Singleton pregnancy
3. Gestational age at recruitment 16-30 weeks
4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT
5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L
6. Not on any hypoglycaemic drug treatment

Previous inclusion criteria:
1. Aged 18 to 45 years
2. Singleton pregnancy
3. Gestational age at recruitment 16-30 weeks
4. Confirmed GDM: Fasting plasma glucose = 5.1 mmol/L and/or the 2-hour = 7.8 mmol/L by 75g OGTT = 16 weeks of pregnancy
5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial = 5.3, post prandial 1 hour of = 7.8 or post prandial 2 hours of = 6.7 mmol/L
6. Not on any hypoglycaemic drug treatment

Exclusion Criteria

1. Any contraindication to metformin
2. History of prepregnant hyperglycaemia
2.1. Type 2 diabetes,
2.2. Impaired glucose tolerance
2.3. Fasting glycaemia
3. Diagnostic 75g OGTT: fasting plasma glucose = 7 or 2-hour glucose = 11.1 mmol/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c is measured using blood samples at baseline and 36 weeks