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Phase I Multiple-Ascending Dose (Japan) (MAD)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00538174
First received: October 1, 2007
Last updated: October 9, 2008
Last verified: October 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Dapagliflozin
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • AEs, vital signs & physical exam [ Time Frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21 ] [ Designated as safety issue: Yes ]
  • ECGs [ Time Frame: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21 ] [ Designated as safety issue: No ]
  • Clinical labs [ Time Frame: scr, Days -1, 2, 7, 12, 14, 15, 21 ] [ Designated as safety issue: No ]
  • Urine safety markers [ Time Frame: Days -1, 1, 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 24 hr PK blood & urine samples [ Time Frame: Days 1 & 14 ] [ Designated as safety issue: No ]
  • Serum glucose, serum insulin, serum c-peptide [ Time Frame: Days -1, 1, 14 ] [ Designated as safety issue: No ]
  • Serum fructosamine [ Time Frame: Days -1, 14, 4 h ] [ Designated as safety issue: No ]
  • OGTT [ Time Frame: Days -2, 13 (after 10 h fast) ] [ Designated as safety issue: No ]
  • 24h urine [ Time Frame: Days -1, 1 & 14 for glucose, creatinine & calcium ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: November 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
2.5 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily up, to 14 days
Experimental: Arm 2
10 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily up, to 14 days
Experimental: Arm 3
20 mg
 Drug: Dapagliflozin
Tablets, Oral, once daily up, to 14 days
Placebo Comparator: Arm 4 Drug: placebo
Tablets, Oral, 0 mg, once daily, up to 14 days

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538174

Locations
Japan
Local Institution
Suita, Osaka, Japan, 5650853
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers K.K.
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00538174     History of Changes
Other Study ID Numbers: MB102-025
Study First Received: October 1, 2007
Last Updated: October 9, 2008
Health Authority: Japan: Pharmaceuticals and Medical Device Agency (PMDA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013