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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Glimepiride; Drug: Dapagliflozin; Drug: Sitagliptin

• Registration Number: NCT00842556
• Lead Sponsor: AstraZeneca

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2009-03
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dapagliflozin + Sitagliptin	Sitagliptin	-
Glimepiride	Glimepiride	-
Sitagliptin	Sitagliptin	-
Dapagliflozin + Glimepiride	Glimepiride	-
Dapagliflozin	Dapagliflozin	-
Dapagliflozin + Glimepiride	Dapagliflozin	-
Dapagliflozin + Sitagliptin	Dapagliflozin	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ppd Development; 🇺🇸 Austin, Texas, United States