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Genetic Variation in OCT1 and Metformin Response
NCT00588172Phase 4
Key facts
- Status
- Withdrawn
- Start
- Jun 2010
- Primary completion
- Jun 2010
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules
- Drugs
- metformin
- Conditions
- type 2 diabetes mellitus (T2DM)
01
Overview
Phase 4, open-label trial of metformin in type 2 diabetes mellitus (T2DM) (2 arms), sponsored by Mayo Clinic. Primary endpoint: Change in glucose area under the curve after a mixed meal at 1 week. Planned start Jun 2010; status: withdrawn.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Wild-type OCT1
Individuals with no nsSNPs
Variant OCT1
Individuals with nsSNPs
03
Who it enrols
Healthy volunteers aged 18-40 with specific OCT1 genotypes (wild-type or variant) and fasting glucose <= 100 mg/dL.
04
Endpoints
Primary
Change in glucose area under the curve after a mixed meal
Secondary
Change in glucose disappearance
Suppression of endogenous glucose production
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