Evaluate Safety as Mono or Combination Therapies With Anti-diabetes Mellitus Drugs in Japanese Subjects With Type 2 Diabetes Mellitus

A Long Term Open Label Study to Evaluate the Safety and Efficacy of Dapagliflozin as Monotherapy or Combination Therapies With Anti-diabetic Drugs in Japanese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control

This is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in Japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes; High Blood Sugar
• Intervention / Treatment: Drug: Dapagliflozin

• Study Type: Interventional
• Enrollment (Actual): 728
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan
    • Research Site
  • Hiroshima, Japan
    • Research Site
  • Kochi, Japan
    • Research Site
  • Osaka, Japan
    • Research Site
  • Shizuoka, Japan
    • Research Site
  • Toyama, Japan
    • Research Site
  • Aichi
    • Nagoya, Aichi, Japan
      • Research Site
    • Owariasahi, Aichi, Japan
      • Research Site
    • Toyohashi, Aichi, Japan
      • Research Site
  • Aomori
    • Hirosaki, Aomori, Japan
      • Research Site
  • Ehime
    • Niihama, Ehime, Japan
      • Research Site
  • Fukuoka
    • Itoshima, Fukuoka, Japan
      • Research Site
    • Yukuhashi, Fukuoka, Japan
      • Research Site
  • Gunma
    • Annaka, Gunma, Japan
      • Research Site
    • OTA, Gunma, Japan
      • Research Site
  • Hiroshima
    • Aki-gun, Hiroshima, Japan
      • Research Site
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Research Site
  • Kagawa
    • Sanuki, Kagawa, Japan
      • Research Site
    • Takamatsu, Kagawa, Japan
      • Research Site
  • Kanagawa
    • Kamakura, Kanagawa, Japan
      • Research Site
    • Kawasaki, Kanagawa, Japan
      • Research Site
    • Yokohama, Kanagawa, Japan
      • Research Site
    • Yokohamashi, Kanagawa, Japan
      • Research Site
    • Zushi, Kanagawa, Japan
      • Research Site
  • Miyagi
    • Sendai, Miyagi, Japan
      • Research Site
  • Nagano
    • Matsumoto, Nagano, Japan
      • Research Site
  • Osaka
    • Suita, Osaka, Japan
      • Research Site
  • Shiga
    • Otsu, Shiga, Japan
      • Research Site
  • Shizuoka
    • Atami, Shizuoka, Japan
      • Research Site
  • Tokushima
    • Komatsushima, Tokushima, Japan
      • Research Site
  • Tokyo
    • Chiyoda, Tokyo, Japan
      • Research Site
    • Chuo, Tokyo, Japan
      • Research Site
    • Mitaka, Tokyo, Japan
      • Research Site
    • OTA, Tokyo, Japan
      • Research Site
    • Shibuya, Tokyo, Japan
      • Research Site
    • Shinjuku, Tokyo, Japan
      • Research Site
    • Taito, Tokyo, Japan
      • Research Site
  • Toyama
    • Takaoka, Toyama, Japan
      • Research Site
  • Yamaguchi
    • UBE, Yamaguchi, Japan
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures
• Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)
• diagnosed with type2 DM ; ≥6.5% and ≤10% at 1 week before treatment started

Exclusion Criteria:

• Type 1 diabetes mellitus,
• FPG >240 mg/dL before treatment started
• Subjects who have history of unstable or rapidly progressing renal disease
• Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
• Significant cardiovascular history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open label treatment	Drug: Dapagliflozin; Oral Dose 5 or 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Adverse Events	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to adverse events	Long-term treatment up to 52 weeks
Proportion of Participants With Serious Adverse Events	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to serious adverse events	Long-term treatment up to 52 weeks
Proportion of Participants With At Least One Episode of Hypoglycemia	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to occurrence of hypoglycemia	Long-term treatment up to 52 weeks
Mean Change in Hematocrit	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in hematocrit	Baseline to Week 52
Mean Change in Alanine Aminotransferase (ALT)	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in alanine aminotransferase	Baseline to Week 52
Mean Change in Aspartate Aminotransferase (AST)	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in aspartate aminotransferase	Baseline to Week 52
Mean Change in Blood Urea Nitrogen (BUN)	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood urea nitrogen	Baseline to Week 52
Mean Change in Magnesium	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in magnesium (1 mEq/L equivalent to 0.50 mmol/L)	Baseline to Week 52
Mean Change in Serum Uric Acid	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in serum uric acid	Baseline to Week 52
Mean Change in Seated Heart Rate	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in pulse	Baseline to Week 52
Mean Change in Seated Diastolic Blood Pressure	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure	Baseline to Week 52
Mean Change in Seated Systolic Blood Pressure	To evaluate the safety and tolerability of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in blood pressure	Baseline to Week 52

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in HbA1c Levels	To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in HbA1c	Baseline to Week 52
Mean Change in Body Weight	To evaluate the efficacy of long-term treatment up to 52 weeks with the dosing regimen of dapagliflozin, where it started with 5 mg and titrated up to 10 mg depending on participant's condition of glycemic control, in regard to the change in body weight	Baseline to Week 52

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Bristol-Myers Squibb
• Investigators: Study Director: Dr Jisin Yang, MD, AstraZeneca KK

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 11, 2011

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: November 22, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Clinical trial; Type 2 Diabetes Mellitus; Phase3
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: D1692C00012