Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00545584

First received: October 16, 2007

Last updated: April 19, 2011

Last verified: April 2011

History of Changes

Results First Received: April 19, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Diabetes Mellitus, Non-Insulin-Dependent
Interventions:	Drug: sitagliptin phosphate Behavioral: Comparator: Diet Behavioral: Comparator: Physical Activity

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
1512 subjects were selected/screened, 380 subjects failed screening, leaving 1132 subjects who were randomized.

Reporting Groups

Description

Sitagliptin With Standard of Care

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

No specific intervention (standard recommendation) on physical exercise and diet.

Sitagliptin With Diet Advice

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet which includes advice on diet with a leaflet and a diary

Sitagliptin With Diet and Physical Activity Advice

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

Participant Flow: Overall Study

	Sitagliptin With Standard of Care	Sitagliptin With Diet Advice	Sitagliptin With Diet and Physical Activity Advice
STARTED	412	414	306 ^[1]
COMPLETED	333	334	250
NOT COMPLETED	79	80	56
Only one reason for discontinuation	62	61	48
Two or more reasons for discontinuation	17	19	8

[1]	306 subjects were randomized but only 305 were treated.

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin With Standard of Care	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: No specific intervention (standard recommendation) on physical exercise and diet.
Sitagliptin With Diet Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet which includes advice on diet with a leaflet and a diary
Sitagliptin With Diet and Physical Activity Advice	Subjects received sitagliptin 100 mg once daily for 26 Weeks, and: Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.
Total	Total of all reporting groups

Baseline Measures

	Sitagliptin With Standard of Care	Sitagliptin With Diet Advice	Sitagliptin With Diet and Physical Activity Advice	Total
Number of Participants [units: participants]	362	358	265	985
Age ^[1] [units: years] Mean ± Standard Deviation	58.26 ± 10.04	57.47 ± 9.12	57.30 ± 9.90	57.71 ± 9.68
Gender ^[1] [units: participants]
Female	181	175	126	482
Male	181	183	139	503

[1]	The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin.

Outcome Measures

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1. Primary:

Hemoglobin A1c Measurement [ Time Frame: Baseline and Week 24 ]

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2. Secondary:

Fasting Plasma Glucose (FPG) Measurement [ Time Frame: Baseline and 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: 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
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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:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00545584 History of Changes
Other Study ID Numbers:	MK-0431-078, 2007_023
Study First Received:	October 16, 2007
Results First Received:	April 19, 2011
Last Updated:	April 19, 2011
Health Authority:	France: Ministry of Health

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