MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00532935

First received: September 19, 2007

Last updated: January 5, 2011

Last verified: January 2011

History of Changes

Results First Received: September 23, 2010

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: Comparator: pioglitazone

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: 19-Mar-2008 Last Patient Last Visit: 23-Oct-2009 Seventy-four medical clinics worldwide (19 sites in the United States, 31 in Eastern Europe, and 24 in the rest of the world).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-78 years old with Type 2 Diabetes Mellitus (T2DM), drug-naïve (off antihyperglycemic agent [AHA] for at least 3 months prior to screening, and a maximum 4 weeks cumulative AHA therapy over the previous 3 years), hemoglobin A1C 7.5 to 12% were eligible. Eligible patients underwent a 2-week placebo run-in period prior to randomization.

Reporting Groups

Description

Sitagliptin/Metformin Fixed-Dose Combination

The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.

Pioglitazone

The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.

Participant Flow: Overall Study

	Sitagliptin/Metformin Fixed-Dose Combination	Pioglitazone
STARTED	261 ^[1]	256 ^[1]
COMPLETED	210	204
NOT COMPLETED	51	52
Adverse Event	11	12
Lack of Efficacy	0	3
Lost to Follow-up	10	6
Physician Decision	4	5
Pregnancy	1	0
Protocol Violation	4	2
Withdrawal by Subject	10	9
Protocol Specific Criteria	11	15

[1]	Excludes 1 patient who was randomized twice at different sites.

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin/Metformin Fixed-Dose Combination	The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC 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. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
Pioglitazone	The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
Total	Total of all reporting groups

Baseline Measures

	Sitagliptin/Metformin Fixed-Dose Combination	Pioglitazone	Total
Number of Participants [units: participants]	261	256	517
Age [units: years] Mean ± Standard Deviation	52.4 ± 10.7	52.2 ± 11	52.3 ± 10.8
Gender [units: participants]
Female	118	122	240
Male	143	134	277
Race/Ethnicity, Customized [units: participants]
White	168	167	335
Black	6	5	11
American Indian	2	0	2
Asian	58	55	113
Multi-racial	27	29	56
Hemoglobin A1C (A1C) [units: Percent of glycosylated hemoglobin (A1C)] Mean ± Standard Deviation	9.0 ± 1.3	8.9 ± 1.3	8.9 ± 1.3
Fasting Plasma Glucose (FPG) [units: mg/dL] Mean ± Standard Deviation	190.6 ± 53.4	188.9 ± 57.1	189.8 ± 55.2
2-Hour Post-Meal Glucose (2-HR PMG) [units: mg/dL] Mean ± Standard Deviation	273.7 ± 84.8	278.8 ± 86.4	276.2 ± 85.5

Outcome Measures

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1. Primary:

Change From Baseline in A1C at Week 32 [ Time Frame: Baseline and Week 32 ]

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2. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 [ Time Frame: Baseline and Week 1 ]

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3. Secondary:

Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 [ Time Frame: Baseline and Week 32 ]

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4. Secondary:

Change From Baseline in FPG at Week 32 [ Time Frame: Baseline and Week 32 ]

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5. Secondary:

Percent of Participants With A1C <7.0% at Week 32 [ Time Frame: Week 32 ]

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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: 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.

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
Unknown to the Sponsor and the investigators, two patients in the study were randomized twice (each at two different sites). Data for these patients were deemed unreliable and excluded from all analyses (efficacy and safety).

Results Point of Contact:

Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00532935 History of Changes
Other Study ID Numbers:	MK-0431A-066, 2007_510
Study First Received:	September 19, 2007
Results First Received:	September 23, 2010
Last Updated:	January 5, 2011
Health Authority:	United States: Food and Drug Administration

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