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Trial Outcomes & Findings for Genetic Basis for Variation in the Renal Elimination of Metformin (NCT NCT00187720)

NCT ID: NCT00187720

Last Updated: 2013-01-10

Results Overview

To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours

Results posted on

2013-01-10

Participant Flow

Dates of recruitment were 5/2003 through 4/10/2007. Location was General Clinical Research Center (GCRC) at San Francisco General Hospital.

Participant milestones

Participant milestones
Measure
Organic Cation Transporter 2 (OCT2)-Variant Group
Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
Organic Cation Transporter 2 (OCT2)-Reference Group
Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
Overall Study
STARTED
9
14
Overall Study
COMPLETED
9
14
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genetic Basis for Variation in the Renal Elimination of Metformin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
OCT2-reference Group
n=14 Participants
Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
OCT2-variant Group
n=9 Participants
Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=5 Participants
9 Participants
n=7 Participants
23 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
27.3 years
STANDARD_DEVIATION 6.6 • n=5 Participants
31.2 years
STANDARD_DEVIATION 5.5 • n=7 Participants
28.8 years
STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male
Female
9 Participants
n=5 Participants
4 Participants
n=7 Participants
13 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
5 Participants
n=7 Participants
10 Participants
n=5 Participants
Region of Enrollment
United States
14 participants
n=5 Participants
9 participants
n=7 Participants
23 participants
n=5 Participants

PRIMARY outcome

Timeframe: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours

Population: Analysis was per protocol. The sample size of 23 subjects will enable us to detect a significant difference (at the p \< 0.05 level; α = 0.05, β = 0.80) in the renal clearance of metformin between individuals who are homozygous for the reference OCT2 and those who carry the OCT2 variant A270S allele.

To test whether individuals with genetic variants of the human organic cation transporter, OCT2, exhibit altered renal elimination of metformin we will measure the difference in renal clearance between reference and variant groups.

Outcome measures

Outcome measures
Measure
OCT2-variant Group
n=9 Participants
The renal clearance of metformin in subjects heterozygous for the variant OCT2 genotype (808G/T, \*3D) following a single oral dose of 850 mg of metformin.
OCT2-reference Group
n=14 Participants
The renal clearance of metformin in subjects homozygous for the reference OCT2 genotype (808G/G) following a single oral dose of 850 mg of metformin.
Renal Clearance of Metformin
614 mL/min
Standard Deviation 158
441 mL/min
Standard Deviation 108

Adverse Events

OCT2-reference Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

OCT2-variant Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathy Giacomini, Ph.D

UCSF

Phone: 4154761936

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place