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Completed

NCT Number: NCT00538174

Phase I Multiple-Ascending Dose (Japan)

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Suita, Osaka, 5650853, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dapagliflozin

Drug

Tablets, Oral, once daily up, to 14 days

Placebo

Drug

Tablets, Oral, 0 mg, once daily, up to 14 days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Dapagliflozin in Diabetic Japanese Subjects

Acronym: MAD

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 2, 2007
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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