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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00842556

Enrollment

Registered

2009-02-12

Start date

2009-03-31

Completion date

2009-05-31

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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)

Interventions

DRUGDapagliflozin

Tablets, Oral, 20 mg, Single Dose

DRUGGlimepiride

Tablets, Oral, 4 mg, Single Dose

DRUGSitagliptin

Tablets, Oral, 100 mg, Single Dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs	72 hours after dosing

Secondary

Measure	Time frame
To assess the safety and tolerability in healthy subjects	15 time points up to 72 hours after dosing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026