Phase I Multiple-Ascending Dose (Japan)
MAD
A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following once daily oral doses of 2.5, 10, and 20 mg of dapagliflozin in diabetic Japanese subjects administered for 14 days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes-mellitus-type-2
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2007
CompletedFirst Posted
Study publicly available on registry
October 2, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMarch 23, 2015
March 1, 2015
6 months
October 1, 2007
March 20, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
AEs, vital signs & physical exam
scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21
ECGs
scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21
Clinical labs
scr, Days -1, 2, 7, 12, 14, 15, 21
Urine safety markers
Days -1, 1, 14
Secondary Outcomes (5)
24 hr PK blood & urine samples
Days 1 & 14
Serum glucose, serum insulin, serum c-peptide
Days -1, 1, 14
Serum fructosamine
Days -1, 14, 4 h
OGTT
Days -2, 13 (after 10 h fast)
24h urine
Days -1, 1 & 14 for glucose, creatinine & calcium
Study Arms (4)
Arm 1
EXPERIMENTAL2.5 mg
Arm 2
EXPERIMENTAL10 mg
Arm 3
EXPERIMENTAL20 mg
Arm 4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Japanese male and female subjects
- Ages 20 to 70 years old
- Established diagnosis of T2DM
- BMI \< 32 kg/m2
- Fasting glucose ≤ 240 mg/dL, while on antidiabetic diet alone
- HbA1C 6.0 - 10.0%
You may not qualify if:
- Symptomatic T2DM defined as polyuria and/or polydipsia within 2 months of enrollment
- History of diabetic ketoacidosis or hyperosmolar nonketotic syndrome
- History of incontinence or bladder dysfunction including nocturia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Local Institution
Suita, Osaka, 5650853, Japan
Related Publications (1)
Kasichayanula S, Chang M, Hasegawa M, Liu X, Yamahira N, LaCreta FP, Imai Y, Boulton DW. Pharmacokinetics and pharmacodynamics of dapagliflozin, a novel selective inhibitor of sodium-glucose co-transporter type 2, in Japanese subjects without and with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Apr;13(4):357-65. doi: 10.1111/j.1463-1326.2011.01359.x.
PMID: 21226818RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers K.K.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2007
First Posted
October 2, 2007
Study Start
November 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
March 23, 2015
Record last verified: 2015-03