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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01072578
First received: February 19, 2010
Last updated: May 31, 2012
Last verified: May 2012

February 19, 2010
May 31, 2012
February 2010
April 2010   (final data collection date for primary outcome measure)
Calculation of derivation of pharmacokinetic variables [ Time Frame: 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01072578 on ClinicalTrials.gov Archive Site
  • 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). [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • To examine the safety and tolerability of the combination of dapagliflozin and metformin [ Time Frame: Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: Dapagliflozin
    Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
  • Drug: Dapagliflozin
    Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days
  • Experimental: 1
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Dapagliflozin
  • Experimental: 2
    Interventions:
    • Drug: Dapagliflozin
    • Drug: Dapagliflozin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01072578
D1691C00004
No
AstraZeneca
AstraZeneca
Bristol-Myers Squibb
Principal Investigator: Georg Golor PAREXEL International GmbH
Study Director: Thomas Koernicke PAREXEL International GmbH
AstraZeneca
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP