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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Dapagliflozin

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring Phase3, Clinical trial, Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label treatment

Arm Description

Outcomes

Primary Outcome Measures

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

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

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

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

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

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

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

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)

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01294436

First Posted

February 10, 2011

Last Updated

November 22, 2013

Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01294436

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type2 Diabetes, High Blood Sugar

Keywords

Phase3, Clinical trial, Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

728 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label treatment

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Intervention Description

Oral Dose 5 or 10 mg

Primary Outcome Measure Information:

Title

Proportion of Participants With Adverse Events

Description

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

Time Frame

Long-term treatment up to 52 weeks

Title

Proportion of Participants With Serious Adverse Events

Description

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

Time Frame

Long-term treatment up to 52 weeks

Title

Proportion of Participants With At Least One Episode of Hypoglycemia

Description

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

Time Frame

Long-term treatment up to 52 weeks

Title

Mean Change in Hematocrit

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Alanine Aminotransferase (ALT)

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Aspartate Aminotransferase (AST)

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Blood Urea Nitrogen (BUN)

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Magnesium

Description

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)

Time Frame

Baseline to Week 52

Title

Mean Change in Serum Uric Acid

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Seated Heart Rate

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Seated Diastolic Blood Pressure

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Seated Systolic Blood Pressure

Description

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

Time Frame

Baseline to Week 52

Other Pre-specified Outcome Measures:

Title

Mean Change in HbA1c Levels

Description

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

Time Frame

Baseline to Week 52

Title

Mean Change in Body Weight

Description

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

Time Frame

Baseline to Week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Jisin Yang, MD

Organizational Affiliation

AstraZeneca KK

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Nagoya

State/Province

Aichi

Country

Japan

Facility Name

Research Site

City

Owariasahi

State/Province

Aichi

Country

Japan

Facility Name

Research Site

City

Toyohashi

State/Province

Aichi

Country

Japan

Facility Name

Research Site

City

Hirosaki

State/Province

Aomori

Country

Japan

Facility Name

Research Site

City

Niihama

State/Province

Ehime

Country

Japan

Facility Name

Research Site

City

Itoshima

State/Province

Fukuoka

Country

Japan

Facility Name

Research Site

City

Yukuhashi

State/Province

Fukuoka

Country

Japan

Facility Name

Research Site

City

Annaka

State/Province

Gunma

Country

Japan

Facility Name

Research Site

City

OTA

State/Province

Gunma

Country

Japan

Facility Name

Research Site

City

Aki-gun

State/Province

Hiroshima

Country

Japan

Facility Name

Research Site

City

Sapporo

State/Province

Hokkaido

Country

Japan

Facility Name

Research Site

City

Sanuki

State/Province

Kagawa

Country

Japan

Facility Name

Research Site

City

Takamatsu

State/Province

Kagawa

Country

Japan

Facility Name

Research Site

City

Kamakura

State/Province

Kanagawa

Country

Japan

Facility Name

Research Site

City

Kawasaki

State/Province

Kanagawa

Country

Japan

Facility Name

Research Site

City

Yokohamashi

State/Province

Kanagawa

Country

Japan

Facility Name

Research Site

City

Yokohama

State/Province

Kanagawa

Country

Japan

Facility Name

Research Site

City

Zushi

State/Province

Kanagawa

Country

Japan

Facility Name

Research Site

City

Sendai

State/Province

Miyagi

Country

Japan

Facility Name

Research Site

City

Matsumoto

State/Province

Nagano

Country

Japan

Facility Name

Research Site

City

Suita

State/Province

Osaka

Country

Japan

Facility Name

Research Site

City

Otsu

State/Province

Shiga

Country

Japan

Facility Name

Research Site

City

Atami

State/Province

Shizuoka

Country

Japan

Facility Name

Research Site

City

Komatsushima

State/Province

Tokushima

Country

Japan

Facility Name

Research Site

City

Chiyoda

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

Chuo

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

Mitaka

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

OTA

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

Shibuya

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

Shinjuku

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

Taito

State/Province

Tokyo

Country

Japan

Facility Name

Research Site

City

Takaoka

State/Province

Toyama

Country

Japan

Facility Name

Research Site

City

UBE

State/Province

Yamaguchi

Country

Japan

Facility Name

Research Site

City

Fukuoka

Country

Japan

Facility Name

Research Site

City

Hiroshima

Country

Japan

Facility Name

Research Site

City

Kochi

Country

Japan

Facility Name

Research Site

City

Osaka

Country

Japan

Facility Name

Research Site

City

Shizuoka

Country

Japan

Facility Name

Research Site

City

Toyama

Country

Japan

Type2 Diabetes, High Blood Sugar

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial