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

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ClinicalTrials.gov Identifier: NCT00538174
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. AEs, vital signs & physical exam [ Time Frame: scr, Days -3, -1, 1, 2, 7, 12, 13, 14, 15, 21 ]
  2. ECGs [ Time Frame: scr, Days -1, 1, 2, 7, 12, 13, 14, 15, 21 ]
  3. Clinical labs [ Time Frame: scr, Days -1, 2, 7, 12, 14, 15, 21 ]
  4. Urine safety markers [ Time Frame: Days -1, 1, 14 ]

Secondary Outcome Measures :
  1. 24 hr PK blood & urine samples [ Time Frame: Days 1 & 14 ]
  2. Serum glucose, serum insulin, serum c-peptide [ Time Frame: Days -1, 1, 14 ]
  3. Serum fructosamine [ Time Frame: Days -1, 14, 4 h ]
  4. OGTT [ Time Frame: Days -2, 13 (after 10 h fast) ]
  5. 24h urine [ Time Frame: Days -1, 1 & 14 for glucose, creatinine & calcium ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538174


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

Additional Information:
Publications of Results:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00538174     History of Changes
Other Study ID Numbers: MB102-025
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015

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