A Study Assessing Saxagliptin Treatment in Type 2 Diabetic Subjects Who Are Not Controlled With TZD Therapy Alone

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00295633

First received: February 22, 2006

Last updated: August 4, 2010

Last verified: June 2010

History of Changes

Results First Received: August 17, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Type 2
Interventions:	Drug: Saxagliptin Drug: Placebo Drug: pioglitazone Drug: rosiglitazone 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 Plus Open-label Thiazolidinedione (TZD)	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
Saxagliptin 5 mg Plus Open-label TZD	The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
Placebo Plus Open-label TZD	The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.

Participant Flow: Overall Study

	Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)	Saxagliptin 5 mg Plus Open-label TZD	Placebo Plus Open-label TZD
STARTED	195	186	184
Completed Study Without Being Rescued	88	82	51
COMPLETED	133	119	108
NOT COMPLETED	62	67	76
Lack of Efficacy	19	7	16
Withdrawal of consent by subject	16	16	26
Adverse Event	9	17	9
Lost to Follow-up	6	11	7
Physician Decision	9	10	8
Poor/Noncompliance	2	2	6
Subject No Longer Meets Study Criteria	0	3	3
Death	1	1	0
Administrative reason by sponsor	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Saxagliptin 2.5 mg Plus Open-label TZD	The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
Saxagliptin 5 mg Plus Open-label TZD	The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
Placebo Plus Open-label TZD	The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
Total	Total of all reporting groups

Baseline Measures

	Saxagliptin 2.5 mg Plus Open-label TZD	Saxagliptin 5 mg Plus Open-label TZD	Placebo Plus Open-label TZD	Total
Number of Participants [units: participants]	195	186	184	565
Age [units: years] Mean ± Standard Deviation	54.85 ± 9.73	53.22 ± 10.56	54.01 ± 10.08	54.04 ± 10.13
Gender [units: participants]
Female	89	97	99	285
Male	106	89	85	280

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]

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2. Secondary:

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

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3. Secondary:

Percentage of Participants Achieving A1c <7% at Week 24 [ Time Frame: Week 24 ]

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4. 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

Publications:

Hollander P, Li J, Allen E, Chen R; CV181-013 Investigators. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone. J Clin Endocrinol Metab. 2009 Dec;94(12):4810-9. Epub 2009 Oct 28.

Publications automatically indexed to this study:

Karyekar C, Donovan M, Allen E, Fleming D, Ravichandran S, Chen R. Efficacy and safety of saxagliptin combination therapy in US patients with type 2 diabetes. Postgrad Med. 2011 Jul;123(4):63-70.

Hollander PL, Li J, Frederich R, Allen E, Chen R; CV181013 Investigators. Safety and efficacy of saxagliptin added to thiazolidinedione over 76 weeks in patients with type 2 diabetes mellitus. Diab Vasc Dis Res. 2011 Apr;8(2):125-35.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00295633 History of Changes
Other Study ID Numbers:	CV181-013
Study First Received:	February 22, 2006
Results First Received:	August 17, 2009
Last Updated:	August 4, 2010
Health Authority:	United States: Food and Drug Administration

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