A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose

Healthy Volunteers Clinical Trial

Official title:

An Open-label, Randomised, Two-period Crossover Study to Assess the Effect of Dapagliflozin on Percent Inhibition of Glucose Re-absorption When Administered Once a Day (10 mg OD) Versus Twice a Day (5 mg BID) in Healthy Male and Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072578
• Other study ID #: D1691C00004
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2010
• Last updated: May 31, 2012
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female healthy volunteers must be post-menopausal (cessation of menses >1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination

• Have normal physical exam, vital signs ECG findings, and laboratory values

Exclusion Criteria:

• Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization

• History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator

• Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dapagliflozin
Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
• Dapagliflozin
Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of derivation of pharmacokinetic variables		Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5	No
Secondary	Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP).		plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals	No
Secondary	To examine the safety and tolerability of the combination of dapagliflozin and metformin		Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later	Yes