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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00842556
First received: February 11, 2009
Last updated: June 6, 2014
Last verified: June 2014
  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 1

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:


Further study details as provided by AstraZeneca:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Sitagliptin
Anti-Arrhythmia Agents
Cardiovascular Agents
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014