Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects - Full Text View

Sponsor:	Bristol-Myers Squibb
Collaborator:	AstraZeneca
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00842556

Purpose

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)

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Dapagliflozin Drug: Glimepiride Drug: Sitagliptin	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Drug Reactions

Drug Information available for: Glimepiride BMS 512148 Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability in healthy subjects [ Time Frame: 15 time points up to 72 hours after dosing ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	March 2009
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Dapagliflozin	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148
Active Comparator: Glimepiride	Drug: Glimepiride Tablets, Oral, 4 mg, Single Dose Other Name: Amaryl
Active Comparator: Dapagliflozin + Glimepiride	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: Glimepiride Tablets, Oral, 4 mg, Single Dose Other Name: Amaryl
Active Comparator: Sitagliptin	Drug: Sitagliptin Tablets, Oral, 100 mg, Single Dose Other Name: Januvia
Active Comparator: Dapagliflozin + Sitagliptin	Drug: Dapagliflozin Tablets, Oral, 20 mg, Single Dose Other Name: BMS-512148 Drug: Sitagliptin Tablets, Oral, 100 mg, Single Dose Other Name: Januvia

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842556

Locations

United States, Texas
Ppd Development
Austin, Texas, United States, 78744

Sponsors and Collaborators

Bristol-Myers Squibb

AstraZeneca

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00842556 History of Changes
Other Study ID Numbers:	MB102-037
Study First Received:	February 11, 2009
Last Updated:	February 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Sitagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

Immunosuppressive Agents
Immunologic Factors
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012