Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

This study has been completed.

Sponsor:

Collaborator:

Bristol-Myers Squibb

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00698932

First received: June 16, 2008

Last updated: August 17, 2011

Last verified: August 2011

History of Changes

Results First Received: September 20, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Type 2 Diabetes
Interventions:	Drug: Saxagliptin Drug: 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
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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 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Participant Flow: Overall Study

	Saxagliptin 5 mg	Placebo
STARTED	284 ^[1]	284 ^[1]
COMPLETED	262 ^[2]	248 ^[2]
NOT COMPLETED	22	36
Adverse Event	0	2
Incorrect enrollment	0	2
Study specific discontinuation criteria	3	4
Withdrawal by Subject	11	23
Lost to Follow-up	6	1
Severe non-compliance to protocol	1	2
Safety reasons	0	2
Death	1	0

[1]	Randomized and treated
[2]	Completed 24 Weeks of treatment

Baseline Characteristics

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Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks
Total	Total of all reporting groups

Baseline Measures

	Saxagliptin 5 mg	Placebo	Total
Number of Participants [units: participants]	284	284	568
Age [units: Years] Mean ± Standard Deviation	51.23 ± 10.04	51.57 ± 10.34	51.4 ± 10.18
Gender [units: Participants]
Female	124	129	253
Male	160	155	315

Outcome Measures

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1. Primary:

Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [ Time Frame: Baseline , Week 24 ]

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Measure Type	Primary
Measure Title	Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
Measure Description	Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. HbA1c data were excluded on and after rescue medication.
Time Frame	Baseline , Week 24
Safety Issue	No

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.
Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Wk 24 LOCF for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. If participant received rescue medication, that measurement must have been taken before rescue.

Reporting Groups

	Description
Saxagliptin 5 mg	Saxagliptin 5 mg tablet, once daily (OD) for 24 weeks
Placebo	Placebo tablet, once daily( OD) for 24 weeks

Measured Values

	Saxagliptin 5 mg	Placebo
Number of Participants Analyzed [units: participants]	277	274
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c) [units: percent] Mean ± Standard Error
Baseline	8.15 ± 0.050	8.14 ± 0.050
Week 24	7.25 ± 0.063	7.75 ± 0.076
Adjusted Mean Change from Baseline	-0.84 ± 0.067	-0.34 ± 0.065

Statistical Analysis 1 for Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001
Mean Difference (Net) ^[4]	-0.50
Standard Error of the mean	± 0.079
95% Confidence Interval	( -0.65 to -0.34 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
	*adjusted for baseline HbA1c
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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2. Secondary:

Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 24 ]

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3. Secondary:

Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 24 ]

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4. Secondary:

Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants [ Time Frame: Baseline , Week 24 ]

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5. Secondary:

Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants [ Time Frame: Baseline , Week 24 ]

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6. Secondary:

Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% 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: The Principal Investigator undertakes to provide AstraZeneca as soon as possible with preliminary data and drafts of proposed publications and disclosures, whether oral or in writing, and as soon as available, with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript for any publication or other disclosure to review it and may within such time require that submission for publication or disclosure of the manuscript be delayed

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: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	Peter Öhman, MD, PhD, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00698932 History of Changes
Other Study ID Numbers:	D1680C00005
Study First Received:	June 16, 2008
Results First Received:	September 20, 2010
Last Updated:	August 17, 2011
Health Authority:	China: Food and Drug Administration India: Drugs Controller General of India Philippines: Bureau of Food and Drugs South Korea: Korea Food and Drug Administration (KFDA)

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