CompletedNCT00842556Updated Oct 17, 2016

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

A Phase 1 interventional study of Dapagliflozin and Glimepiride in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by AstraZeneca · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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)

Conditions studied

Type 2 Diabetes Mellitus

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Diabetes Mellitus, Type 2 9,589

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 18 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

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Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Phase 1
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 18 participants (actual)

Study arms

Active comparator
Dapagliflozin
Drug: Dapagliflozin
Active comparator
Glimepiride
Drug: Glimepiride
Active comparator
Dapagliflozin + Glimepiride
Drug: Dapagliflozin · Drug: Glimepiride
Active comparator
Sitagliptin
Drug: Sitagliptin
Active comparator
Dapagliflozin + Sitagliptin
Drug: Dapagliflozin · Drug: Sitagliptin

Interventions

DrugDapagliflozin
Tablets, Oral, 20 mg, Single Dose
Also known as: BMS-512148
DrugGlimepiride
Tablets, Oral, 4 mg, Single Dose
Also known as: Amaryl
DrugSitagliptin
Tablets, Oral, 100 mg, Single Dose
Also known as: Januvia

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Ppd Development
Austin, Texas 78744, United States

References and documents

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2009, a primary completion of May 2009 and a completion of May 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 11, 2009
First posted: Feb 12, 2009
Start: Mar 2009
Primary completionActual: May 2009
CompletionActual: May 2009
Last update: Oct 17, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00842556
Lead sponsor: AstraZeneca
Collaborators: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Feb 12, 2009
Start date: Mar 2009
Primary completion: May 2009
Completion: May 2009
Last update: Oct 17, 2016

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Dapagliflozin · Glimepiride · Sitagliptin

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