Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00885378

First received: April 21, 2009

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

Results First Received: November 2, 2011

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 Mellitus
Interventions:	Drug: Saxagliptin plus metformin IR Drug: Placebo plus metformin IR

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Saxagliptin 2.5 mg + Metformin Immediate Release (IR)	Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
Placebo + Metformin IR	2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
Total	Total of all reporting groups

Baseline Measures

	Saxagliptin 2.5 mg + Metformin Immediate Release (IR)	Placebo + Metformin IR	Total
Number of Participants [units: participants]	74	86	160
Age [units: years] Mean ± Standard Deviation	53.90 ± 10.35	56.60 ± 9.97	55.4 ± 10.20
Gender [units: participants]
Female	34	41	75
Male	40	45	85
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	0	1	1
Asian	2	2	4
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	8	3	11
White	64	80	144
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment [units: participants]
United States	49	56	105
Hungary	8	8	16
Puerto Rico	8	10	18
Germany	9	12	21
Mean Height [units: cm] Mean ± Standard Deviation	168.38 ± 9.56	167.77 ± 8.99	168.05 ± 9.23
Mean Weight [units: kg] Mean ± Standard Deviation	95.85 ± 21.40	91.74 ± 19.87	93.64 ± 20.63
Mean Body Mass Index (BMI) [units: kg / m^2] Mean ± Standard Deviation	33.68 ± 5.94	32.51 ± 6.18	33.05 ± 6.08
Participant Body Mass Index [units: Participants]
< 30 kg / m^2	19	35	54
>= 30 kg / m^2	55	51	106
Mean Duration of Type 2 Diabetes Mellitus ^[1] [units: Years] Mean ± Standard Deviation	5.81 ± 6.37	6.17 ± 4.21	6.00 ± 5.30
Mean Metformin Dose at Baseline [units: mg] Mean ± Standard Deviation	1911.5 ± 376.59	1855.8 ± 330.19	1881.6 ± 352.38

[1]	Mean time since the time of diagnosis of Type 2 Diabetes Mellitus.

Outcome Measures

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1. Primary:

Mean Hemoglobin A1C (A1c) and Change From Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]

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2. Secondary:

Mean Baseline and Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline, Week 12 ]

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3. Secondary:

Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12 [ Time Frame: Week 12 ]

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4. Secondary:

Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12 [ Time Frame: Week 12 ]

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5. Other Pre-specified:

Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary [ Time Frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the double-blind (DB) period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period. ]

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6. Other Pre-specified:

Participants With Reported Hypoglycemia AEs During Double-Blind Treatment Period [ Time Frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period. ]

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7. Other Pre-specified:

Participants With Confirmed Hypoglycemia [ Time Frame: Week 1 to Week 12; AEs are included up to the last treatment day + 1 day or the last visit in the DB period. SAEs are included up to the last of 1) the last treatment day + 30 days or 2) the last visit day + 30 days in the DB period. ]

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8. Other Pre-specified:

Participant Electrocardiogram (ECG) Status at Baseline and Week 12 [ Time Frame: Baseline, Week 12 ]

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9. Other Pre-specified:

Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

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10. Other Pre-specified:

Baseline and Mean Change From Baseline in Participant Heart Rate (HR) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

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11. Other Pre-specified:

Participants Experiencing Changes From Baseline in Laboratory Parameters That Met the Marked Abnormality Criteria [ Time Frame: Baseline, Week 12 ]

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12. Other Pre-specified:

Participants Experiencing Changes From Baseline in Urinalysis Parameters That Met the Marked Abnormality Criteria [ Time Frame: Baseline, Week 12 ]

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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
No text entered.

Results Point of Contact:

Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00885378 History of Changes
Other Study ID Numbers:	CV181-080, EUDRACT #: 2009-010224-25
Study First Received:	April 21, 2009
Results First Received:	November 2, 2011
Last Updated:	December 22, 2011
Health Authority:	United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Germany: Ethics Commission Hungary: National Institute of Pharmacy Hungary: Medical Research Council Ethic Committee for Clinical Pharmacology (MRC-ECCP) Mexico: Federal Commission for Sanitary Risks Protection Mexico: Ethics Committee

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