Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)(COMPLETED)

This study has been completed.

Study NCT00885352 Information provided by Merck

First Received on April 20, 2009. Last Updated on December 27, 2011 History of Changes

Results First Received: November 4, 2011

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 Drug: Comparator: Placebo Drug: Pioglitazone Drug: Metformin Drug: Glipizide

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
Lab abnormalities (the reason for discontinuation cited below) included creatinine, creatinine clearance, and estimated glomerular filtration rate.

Reporting Groups

	Description
Sitagliptin	Sitagliptin 100 mg once daily
Placebo	Placebo to sitagliptin once daily

Participant Flow: Overall Study

	Sitagliptin	Placebo
STARTED	157	156
COMPLETED	149	136
NOT COMPLETED	8	20
Adverse Event	2	3
Lost to Follow-up	2	2
Physician Decision	0	3
Protocol Violation	0	2
Withdrawal by Subject	1	5
Contradiction to study medication	0	2
Excluded medication	2	2
Lab abnormalities	1	1

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin	Sitagliptin 100 mg once daily
Placebo	Placebo to sitagliptin once daily

Baseline Measures

	Sitagliptin	Placebo	Total
Number of Participants [units: participants]	157	156	313
Age [units: years] Mean ± Standard Deviation	55.7 ± 8.7	56.4 ± 9.4	56.1 ± 9.0
Gender [units: participants]
Female	60	58	118
Male	97	98	195
Hemoglobin A1c (A1C) [units: Percent of gylcosylated hemoglobin] Mean ± Standard Deviation	8.8 ± 1.0	8.7 ± 1.0	8.7 ± 1.0
2-hour post-meal glucose (PMG) ^[1] [units: mg/dL] Mean ± Standard Deviation	275.5 ± 66.4	266.0 ± 62.4	270.8 ± 64.5
Fasting plasma glucose (FPG) [units: mg/dL] Mean ± Standard Deviation	179.3 ± 44.3	173.6 ± 38.9	176.5 ± 41.7

[1]	Participant population included 147 sitagliptin participants and 147 placebo participants.

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1c (A1C) at Week 26 [ Time Frame: Baseline and Week 26 ]

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2. Secondary:

Change From Baseline in 2-Hour Post-Meal Glucose (PMG) at Week 26 [ Time Frame: Baseline and Week 26 ]

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3. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 [ Time Frame: Baseline and Week 26 ]

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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 sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00885352 History of Changes
Other Study ID Numbers:	MK-0431-128, 2009_577
Study First Received:	April 20, 2009
Results First Received:	November 4, 2011
Last Updated:	December 27, 2011
Health Authority:	United States: Food and Drug Administration