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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842556
First Posted: February 12, 2009
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • To assess the safety and tolerability in healthy subjects [ Time Frame: 15 time points up to 72 hours after dosing ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842556


Locations
United States, Texas
Ppd Development
Austin, Texas, United States, 78744
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00842556     History of Changes
Other Study ID Numbers: MB102-037
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: October 17, 2016
Last Verified: October 2016

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