A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca, Bristol-Myers Squibb

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01095653

First received: March 26, 2010

Last updated: December 13, 2016

Last verified: December 2016

History of Changes

Results First Received: September 30, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: Dapagliflozin Drug: Metformin Drug: Dapagliflozin Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of 1179 participants enrolled, 514 completed a qualification period. Of these 514 participants, 393 were randomized and received treatment. Of these 393 participants, 343 completed double-blind treatment period.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 5 mg	Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 10 mg	Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)

Participant Flow: Overall Study

	Placebo	Dapagliflozin 5 mg	Dapagliflozin 10 mg
STARTED	132	128	133
COMPLETED	113	113	117
NOT COMPLETED	19	15	16
Lack of Efficacy	3	0	0
Adverse Event	1	4	4
Lost to Follow-up	1	0	4
Withdrawal by Subject	4	5	3
non-compliance, not met criteria, etc.	10	6	5

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants who received at least 1 dose of study medication

Reporting Groups

	Description
Placebo	Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 5 mg	Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Dapagliflozin 10 mg	Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
Total	Total of all reporting groups

Baseline Measures

	Placebo	Dapagliflozin 5 mg	Dapagliflozin 10 mg	Total
Overall Participants Analyzed [Units: Participants]	132	128	133	393

Age [Units: Years] Mean (Standard Deviation)	49.9 (10.87)	53.0 (11.07)	51.2 (9.89)	51.3 (10.67)

Age, Customized [Units: Participants]
Younger than 65 years	120	108	123	351
65 to younger than 75 years	11	14	10	35
75 years and older	1	6	0	7

Gender, Customized [Units: Participants]
Male	87	84	86	257
Female	45	44	47	136

Race/Ethnicity, Customized [Units: Participants]
ASIAN INDIAN	8	8	9	25
CHINESE	117	114	117	348
JAPANESE	1	0	1	2
KOREAN	5	6	5	16
ASIAN OTHER	1	0	1	2

Weight [Units: Kg] Mean (Standard Deviation)	72.18 (13.234)	68.89 (11.429)	70.92 (11.637)	70.68 (12.177)

Body Mass Index (BMI) [Units: Kg/m^2] Mean (Standard Deviation)	25.93 (3.644)	25.17 (3.285)	25.76 (3.434)	25.62 (3.465)

Outcome Measures

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1. Primary:

Adjusted Mean Change From Baseline in Hemoglobin A1C (HbA1c) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

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2. Secondary:

Adjusted Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

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3. Secondary:

Adjusted Mean Change From Baseline in 2-hour Post Liquid Meal Glucose (PLMG) (mg/dL) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

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4. Secondary:

Adjusted Mean Change From Baseline in Total Body Weight (kg) at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

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5. Secondary:

Percentage of Participants Achieving a Therapeutic Glycemic Response (Hemoglobin A1c [HbA1C]) <7.0% at Week 24 (Last Observation Carried Forward [LOCF]) [ Time Frame: From Baseline to Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Anna Maria Langkilde
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01095653 History of Changes
Other Study ID Numbers:	MB102-054
Study First Received:	March 26, 2010
Results First Received:	September 30, 2016
Last Updated:	December 13, 2016

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