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

NCT01072578 | Completed Phase 1

• 1 other identifier: D1691C00004
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers; Inhibition of glucose re-absorption; diabetes; dapagliflozin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Dapagliflozin

2

EXPERIMENTAL

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Research Site

Berlin, Germany

Location

Related Publications (1)

• Tang W, Reele S, Hamer-Maansson JE, Parikh S, de Bruin TW. Dapagliflozin twice daily or once daily: effect on pharmacokinetics and urinary glucose excretion in healthy subjects. Diabetes Obes Metab. 2015 Apr;17(4):423-5. doi: 10.1111/dom.12425. Epub 2015 Jan 12.

  PMID: 25511685 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Georg Golor

  Parexel

  PRINCIPAL INVESTIGATOR

• Thomas Koernicke

  Parexel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 1, 2012

Record last verified: 2012-05

Locations

DE (1)