Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

AstraZeneca1 site in 1 country18 target enrollmentMarch 2009

ConditionsType 2 Diabetes Mellitus

InterventionsDapagliflozin Glimepiride Sitagliptin

DrugsDapagliflozin Glimepiride Sitagliptin

Overview

Phase: Phase 1
Intervention: Dapagliflozin
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 18
Locations: 1
Primary Endpoint: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

May 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
•Body mass index (BMI) of 18 to 32 kg/m2, inclusive BMI = weight (kg)/\[height(m)\]2

Exclusion Criteria

•WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
•Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
•History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
•History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds
•Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1
•History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections