A Study Assessing Saxagliptin Treatment 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:

NCT00374907

First received: September 7, 2006

Last updated: June 3, 2011

Last verified: June 2011

History of Changes

Results First Received: December 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacodynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: Saxagliptin Drug: Placebo Drug: Metformin (blinded) Drug: Metformin (open-label)

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
156 participants were enrolled in the study; 110 participants failed screening; 10 subjects entered lead-in and discontinued prior to randomization.

Reporting Groups

	Description
Saxagliptin 5 mg	Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
Placebo / Metformin	Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).

Participant Flow for 2 periods

Period 1: 12-Week Short-term Period

	Saxagliptin 5 mg	Placebo / Metformin
STARTED	20	16
COMPLETED	17	15
NOT COMPLETED	3	1
Subject Withdrew Consent	3	1

Period 2: 116-Week Short-term + Long-term Period

	Saxagliptin 5 mg	Placebo / Metformin
STARTED	20	16
Completed 12-week Short Term Period	17	15
COMPLETED	7	2
NOT COMPLETED	13	14
Subject Withdrew Consent	8	9
Lack of Efficacy	4	2
Adverse Event	0	2
Lost to Follow-up	1	1

Baseline Characteristics

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Reporting Groups

	Description
Saxagliptin 5 mg	Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
Placebo / Metformin	Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
Total	Total of all reporting groups

Baseline Measures

	Saxagliptin 5 mg	Placebo / Metformin	Total
Number of Participants [units: participants]	20	16	36
Age [units: years] Median ( Full Range )	58 ( 43 to 69 )	55 ( 45 to 69 )	55.5 ( 43 to 69 )
Gender [units: participants]
Female	12	10	22
Male	8	6	14
Race/Ethnicity, Customized [units: participants]
White	16	12	28
Black/African American	3	4	7
Other	1	0	1
Region of Enrollment [units: participants]
North America	20	16	36
Body Mass Index (BMI) [units: kg/m^2] Median ( Full Range )	33.36 ( 24.67 to 39.35 )	32.31 ( 25.56 to 38.55 )	33.01 ( 24.67 to 39.35 )

Outcome Measures

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1. Primary:

Insulin Secretion Rate Area Under the Curve (AUC) During Intravenous (IV)-Oral Hyperglycemic Clamp - Percent Change From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]

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2. Secondary:

Insulin Secretion Rate AUC During IV Hyperglycemic Clamp - Percent Change From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]

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3. Other Pre-specified:

Overall Summary of Adverse Events (AEs) Serious AEs (SAEs), Discontinuations, and Deaths During the ST + LT Treatment Period [ Time Frame: 116 weeks ]

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4. Other Pre-specified:

Marked Laboratory Abnormalities - During ST + LT Treatment Period [ Time Frame: 116 weeks ]

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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:	NCT00374907 History of Changes
Other Study ID Numbers:	CV181-041
Study First Received:	September 7, 2006
Results First Received:	December 26, 2010
Last Updated:	June 3, 2011
Health Authority:	United States: Food and Drug Administration

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