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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-05-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 20 mg, Single Dose

Glimepiride

Group Type ACTIVE_COMPARATOR

Glimepiride

Intervention Type DRUG

Tablets, Oral, 4 mg, Single Dose

Dapagliflozin + Glimepiride

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 20 mg, Single Dose

Glimepiride

Intervention Type DRUG

Tablets, Oral, 4 mg, Single Dose

Sitagliptin

Group Type ACTIVE_COMPARATOR

Sitagliptin

Intervention Type DRUG

Tablets, Oral, 100 mg, Single Dose

Dapagliflozin + Sitagliptin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 20 mg, Single Dose

Sitagliptin

Intervention Type DRUG

Tablets, Oral, 100 mg, Single Dose

Interventions

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Dapagliflozin

Tablets, Oral, 20 mg, Single Dose

Intervention Type DRUG

Glimepiride

Tablets, Oral, 4 mg, Single Dose

Intervention Type DRUG

Sitagliptin

Tablets, Oral, 100 mg, Single Dose

Intervention Type DRUG

Other Intervention Names

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BMS-512148 Amaryl Januvia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes