Pharmacokinetics of Metformin Intolerance

Diabetes Mellitus, Type 2 Clinical Trial

— POMI  

Official title:

Pharmacokinetics of Metformin Intolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361878
• Other study ID #: 2013DM06
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2017
• Last updated: November 29, 2017
• Start date: May 4, 2014
• Est. completion date: May 5, 2016

Study information

• Verified date: November 2017
• Source: NHS Tayside
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharmacokinetic study of metformin intolerance

Description:

This pharmacokinetic study recruited white European individuals with type 2 diabetes, who had previously been exposed to metformin and met the criteria for tolerance or intolerance. Intolerance was defined as previous exposure to metformin (maximum of 1000mg once daily for up to 8 weeks) but discontinued treatment with patient reported or documentation of gastrointestinal upset, leading to discontinuation (Criterion 1). Alternatively, intolerance was defined as inability to increase metformin dose above 500mg without experiencing gastrointestinal side-effects, despite having an HbA1c >53mmol/mol (Criterion 2). Tolerant individuals were defined as those taking 2000mg metformin daily in divided doses, with no side effects. Ten tolerant and ten intolerant individuals were recruited.

Participants gave written consent. They attended the research centre fasted from midnight. A baseline blood test was taken before a single dose of oral metformin was administered at 0900, with further bloods taken at 11 time points over the following 24 hours. A 24 hour urine collection was completed.

Blood samples were analysed for plasma metformin, and serum lactate concentrations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 5, 2016
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• White European

• Type 2 diabetes

• Meet criteria for tolerance or intolerance as described

Exclusion Criteria:

• Estimated glomerular filtration rate (eGFR) <60

• Cognitive impairment

• Pregnancy

• Concurrent treatment with: acarbose, cephalexin, cimetidine, pyrimethamine, or tyrosine kinase inhibitors

• History of gastric bypass

• Evidence of slowed gastric or intestinal motility

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metformin Adverse Reaction

Intervention

Drug:
• Metformin Hydrochloride
Single dose of 500mg oral metformin

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
NHS Tayside	Helmholtz Zentrum München, University of Dundee, University of Southern Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin AUC	Area under the metformin concentration-time curve	24 hours
Secondary	Lactate	Change in lactate concentration (incremental AUC)	24 hours