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

Type2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294436
• Other study ID #: D1692C00012
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2011
• Last updated: November 22, 2013
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 728
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• High Blood Sugar
• Hyperglycemia
• Type2 Diabetes

Intervention

Drug:
• Dapagliflozin
Oral Dose 5 or 10 mg

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes