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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842556
• Other study ID #: MB102-037
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2009
• Last updated: October 14, 2016
• Start date: March 2009
• Est. completion date: May 2009

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin
Tablets, Oral, 20 mg, Single Dose
• Glimepiride
Tablets, Oral, 4 mg, Single Dose
• Sitagliptin
Tablets, Oral, 100 mg, Single Dose

Locations

Country	Name	City	State
United States	Ppd Development	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs		72 hours after dosing	No
Secondary	To assess the safety and tolerability in healthy subjects		15 time points up to 72 hours after dosing	Yes

External Links

•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   MB102-037_Redacted _CSR _synopsis