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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01294436
First received: February 10, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Type2 Diabetes
High Blood Sugar
Drug: Dapagliflozin
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Proportion of Participants With Adverse Events [ Time Frame: Long-term treatment up to 52 weeks ] [ Designated as safety issue: Yes ]
    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

  • Proportion of Participants With Serious Adverse Events [ Time Frame: Long-term treatment up to 52 weeks ] [ Designated as safety issue: Yes ]
    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

  • Proportion of Participants With At Least One Episode of Hypoglycemia [ Time Frame: Long-term treatment up to 52 weeks ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Hematocrit [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Alanine Aminotransferase (ALT) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Aspartate Aminotransferase (AST) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Blood Urea Nitrogen (BUN) [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Magnesium [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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)

  • Mean Change in Serum Uric Acid [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Seated Heart Rate [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Seated Diastolic Blood Pressure [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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

  • Mean Change in Seated Systolic Blood Pressure [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • Mean Change in HbA1c Levels [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    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

  • Mean Change in Body Weight [ Time Frame: Baseline to Week 52 ] [ Designated as safety issue: No ]
    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


Enrollment: 728
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label treatment Drug: Dapagliflozin
Oral Dose 5 or 10 mg

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294436

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Owariasahi, Aichi, Japan
Research Site
Toyohashi, Aichi, Japan
Research Site
Hirosaki, Aomori, Japan
Research Site
Niihama, Ehime, Japan
Research Site
Itoshima, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Annaka, Gunma, Japan
Research Site
OTA, Gunma, Japan
Research Site
Aki-gun, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Sanuki, Kagawa, Japan
Research Site
Takamatsu, Kagawa, Japan
Research Site
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
Sendai, Miyagi, Japan
Research Site
Matsumoto, Nagano, Japan
Research Site
Suita, Osaka, Japan
Research Site
Otsu, Shiga, Japan
Research Site
Atami, Shizuoka, Japan
Research Site
Komatsushima, Tokushima, Japan
Research Site
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
Takaoka, Toyama, Japan
Research Site
UBE, Yamaguchi, Japan
Research Site
Fukuoka, Japan
Research Site
Hiroshima, Japan
Research Site
Kochi, Japan
Research Site
Osaka, Japan
Research Site
Shizuoka, Japan
Research Site
Toyama, Japan
Sponsors and Collaborators
AstraZeneca
Bristol-Myers Squibb
Investigators
Study Director: Dr Jisin Yang, MD AstraZeneca KK
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01294436     History of Changes
Other Study ID Numbers: D1692C00012
Study First Received: February 10, 2011
Results First Received: July 10, 2013
Last Updated: November 22, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Phase3
Clinical trial
Type 2 Diabetes Mellitus

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

ClinicalTrials.gov processed this record on November 23, 2014