Impact of Genetics on Metformin Pharmacokinetics

NCT00187798 | Completed DMC

• 1 other identifier: 928
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Specific Aims: To compare metformin pharmacokinetics in monozygotic and dizygotic twin pairs. Comparing renal clearance of metformin in monozygotic and dizygotic twins will allow us to better understand the influence of heredity on variation in renal elimination. Furthermore, genotyping renal transporter genes in monozygotic and dizygotic twin pairs with significant differences in renal clearance of metformin may give us insight into the genes responsible for this variability.

Conditions

Other Conditions That May Be A Focus of Clinical Attention

Keywords

Healthy Control Twins

Outcome Measures

Primary Outcomes (1)

• To compare metformin pharmacokinetics in monozygotic and dizygotic twin pairs.

  Comparing renal clearance of metformin in monozygotic and dizygotic twins will allow us to better understand the influence of heredity on variation in renal elimination. Furthermore, genotyping renal transporter genes in monozygotic and dizygotic twin pairs with significant differences in renal clearance of metformin may give us insight into the genes responsible for this variability.

  24 hours

Study Arms (1)

Metformin

OTHER

Metformin HCl

Drug: Metformin HCl

Interventions

Metformin HCl DRUG

Subjects will be given a single oral dose in tablet form containing 850 mg of metformin

Also known as: GLUCOPHAGE

Metformin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part of either a monozygotic or dizygotic twin pair.
• Healthy (by medical history and laboratory values).
• Between 18 and 40 years old.

You may not qualify if:

• Taking regular medication other than vitamins.
• Individuals with anemia (hemoglobin \< 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL Pregnant at time of study.
• Diagnosis of hypoglycemia, phlebitis and/or stroke will be excluded.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francsico

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Leabman MK, Giacomini KM. Estimating the contribution of genes and environment to variation in renal drug clearance. Pharmacogenetics. 2003 Sep;13(9):581-4. doi: 10.1097/00008571-200309000-00007.

  PMID: 12972957 BACKGROUND

• Leabman MK, Huang CC, Stryke D, Johns SJ, Kawamoto M, Ferrin TE, DeYoung J, Taylor TR, De La Cruz M, Herskowitz I, Giacomini KM. PharmGKB update: I. Genetic variants of the organic cation transporter 2 (OCT2, SLC22A2). Pharmacol Rev. 2003 Sep;55(3):399. doi: 10.1124/pr.55.3.6. Epub 2003 Jul 17. No abstract available.

  PMID: 12869664 RESULT

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Kathleen Giacomini, PhD

  University of California San Francsico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

US (1)