Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00316082

First received: April 18, 2006

Last updated: November 20, 2009

Last verified: November 2009

History of Changes

Results First Received: August 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Diabetes
Interventions:	Drug: Saxagliptin Drug: Placebo Drug: metformin

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
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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
Saxagliptin 2.5 mg Once in the Morning (QAM)	The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
Saxagliptin 5 mg QAM	The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
Saxagliptin 2.5/5 mg QAM	The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
Saxagliptin 5 mg Once in the Evening (QPM)	The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
Placebo	The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.

Participant Flow: Overall Study

	Saxagliptin 2.5 mg Once in the Morning (QAM)	Saxagliptin 5 mg QAM	Saxagliptin 2.5/5 mg QAM	Saxagliptin 5 mg Once in the Evening (QPM)	Placebo
STARTED	74	74	71	72	74
Completed Study Without Being Rescued	25	35	29	27	31
COMPLETED	41	52	44	46	48
NOT COMPLETED	33	22	27	26	26
Lack of Efficacy	2	3	3	4	6
Withdrawal of Consent by Subject	10	8	2	9	5
Lost to Follow-up	7	6	7	8	6
Poor/noncompliance	6	1	4	1	4
Adverse Event	4	2	5	1	3
Subject no longer meets study criteria	3	1	2	2	1
Physician Decision	1	1	2	1	1
Death	0	0	1	0	0
Administrative reason by sponsor	0	0	1	0	0

Baseline Characteristics

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Reporting Groups

	Description
Saxagliptin 2.5 mg Once in the Morning (QAM)	The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
Saxagliptin 5 mg QAM	The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
Saxagliptin 2.5/5 mg QAM	The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
Saxagliptin 5 mg Once in the Evening (QPM)	The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
Placebo	The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
Total	Total of all reporting groups

Baseline Measures

	Saxagliptin 2.5 mg Once in the Morning (QAM)	Saxagliptin 5 mg QAM	Saxagliptin 2.5/5 mg QAM	Saxagliptin 5 mg Once in the Evening (QPM)	Placebo	Total
Number of Participants [units: participants]	74	74	71	72	74	365
Age [units: years] Mean ± Standard Deviation	55.24 ± 10.44	54.66 ± 9.71	54.28 ± 10.93	55.11 ± 10.35	55.57 ± 10.32	54.98 ± 10.31
Gender [units: participants]
Female	49	36	34	39	39	197
Male	25	38	37	33	35	168

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1 (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]

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2. Secondary:

Change From Baseline in A1C at Week 24 - Saxagliptin 5 mg QPM [ Time Frame: Baseline, Week 24 ]

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3. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ]

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4. Secondary:

Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ]

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5. Secondary:

Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: clinical.trials@bms.com

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00316082 History of Changes
Other Study ID Numbers:	CV181-038
Study First Received:	April 18, 2006
Results First Received:	August 17, 2009
Last Updated:	November 20, 2009
Health Authority:	United States: Food and Drug Administration

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