MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00482729

First received: May 31, 2007

Last updated: February 3, 2015

Last verified: February 2015

History of Changes

Results First Received: December 9, 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:	Type 2 Diabetes Mellitus
Interventions:	Drug: sitagliptin phosphate (+) metformin hydrochloride 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
First Patient In: 26-Jun-2007; Last Patient Last Visit for end of study: 28-Apr-2009; Two-hundred four medical clinics in the United States (US) and 5 in Puerto Rico.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-78 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic control (hemoglobin A1c [A1C] >7.5% at screening visit) who were appropriate for treatment with oral antihyperglycemic therapy and had not been on an anti-hyperglycemic agent (AHA) in the last 4 months were eligible to participate.

Reporting Groups

Description

Sita/Met FDC

The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.

Metformin

The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.

Participant Flow: Overall Study

	Sita/Met FDC	Metformin
STARTED	626 ^[1]	624 ^[2]
Completed Phase A	484	482
Completed Phase B	409	406
COMPLETED	409	406
NOT COMPLETED	217	218
Adverse Event	29	33
Creatinine/Creatinine Clearance Criteria	0	2
Hyperglycemia Criteria	7	5
Lack of Efficacy	4	16
Lost to Follow-up	86	66
Physician Decision	10	7
Pregnancy	4	2
Protocol Violation	10	18
Withdrawal by Subject	67	69

[1]	Site 079011301 was identified as non-compliant and 1 patient was excluded from all analysis
[2]	Site 079011301 was identified as non-compliant and 3 patients were excluded from all analysis

Baseline Characteristics

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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.
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Reporting Groups

	Description
Sita/Met FDC	The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Metformin	The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
Total	Total of all reporting groups

Baseline Measures

	Sita/Met FDC	Metformin	Total
Number of Participants [units: participants]	625	621	1246
Age [units: years] Mean ± Standard Deviation	49.4 ± 10.5	50.0 ± 10.5	49.7 ± 10.5
Gender [units: participants]
Female	272	266	538
Male	353	355	708
Race/Ethnicity, Customized [units: Participants]
Asian	17	24	41
Black	82	88	170
White	508	489	997
Other	18	20	38
Hemoglobin A1c (A1C) [units: Percent] Mean ± Standard Deviation	9.91 ± 1.83	9.83 ± 1.77	9.87 ± 1.80

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1c (A1C) at Week 18 [ Time Frame: Baseline and Week 18 ]

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2. Secondary:

Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: Week 18 ]

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3. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ]

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4. Other Pre-specified:

Change From Baseline in A1C at Week 44 [ Time Frame: Baseline and Week 44 ]

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5. Other Pre-specified:

Number of Patients With A1C < 7.0% at Week 44 [ Time Frame: Week 44 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
Site 079011301 was non-compliant with Good Clinical Practice (GCP). Data from the 4 patients at this site are included in the Participant Flow summary, but are excluded from all other summaries and analyses.

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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact:

Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00482729 History of Changes
Other Study ID Numbers:	0431A-079, MK0431A-079, 2007_548
Study First Received:	May 31, 2007
Results First Received:	December 9, 2009
Last Updated:	February 3, 2015
Health Authority:	United States: Food and Drug Administration

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