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

March 20, 2015 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 5650853
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Arm 4
Drug: placebo
Tablets, Oral, 0 mg, once daily, up to 14 days
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers K.K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria

October 1, 2007

First Posted (Estimate)

October 2, 2007

Study Record Updates

Last Update Posted (Estimate)

March 23, 2015

Last Update Submitted That Met QC Criteria

March 20, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB102-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Dapagliflozin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe