Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00509262

First received: July 27, 2007

Last updated: February 28, 2012

Last verified: February 2012

History of Changes

Results First Received: February 28, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic
Interventions:	Drug: Sitagliptin Drug: Glipizide Drug: Placebo for Sitagliptin Drug: Placebo for 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
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One site was identified as non-compliant with some of the requirements of Good Clinical Practice. For this reason, data from the 3 participants randomized at this site were deemed unreliable and were removed from all analyses.

Reporting Groups

	Description
Sitagliptin	Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
Glipizide	Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin

Participant Flow: Overall Study

	Sitagliptin	Glipizide
STARTED	211	212
COMPLETED	164	170
NOT COMPLETED	47	42
Adverse Event	16	18
Not specified	2	2
Lack of Efficacy	1	0
Lost to Follow-up	1	6
Physician Decision	1	3
Protocol Violation	2	2
Withdrawal by Subject	24	11

Baseline Characteristics

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Reporting Groups

	Description
Sitagliptin	Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
Glipizide	Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
Total	Total of all reporting groups

Baseline Measures

	Sitagliptin	Glipizide	Total
Number of Participants [units: participants]	211	212	423
Age [units: years] Mean ± Standard Deviation	64.2 ± 10.7	64.2 ± 9.4	64.2 ± 10.1
Gender [units: participants]
Female	80	90	170
Male	131	122	253

Outcome Measures

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1. Primary:

Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 [ Time Frame: Baseline to Week 54 ]

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Measure Type	Primary
Measure Title	Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54
Measure Description	A1C represents percentage of glycosylated hemoglobin.
Time Frame	Baseline to Week 54
Safety Issue	No

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.
The per protocol population required that a participant had measurements both at baseline and at Week 54, and did not have any major protocol violations (e.g. drug compliance <75%, addition of prohibited antihyperglycemic agent, or incorrect double-blind study medication). No missing data were imputed.

Reporting Groups

	Description
Sitagliptin	Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
Glipizide	Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin

Measured Values

	Sitagliptin	Glipizide
Number of Participants Analyzed [units: participants]	135	142
Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54 [units: Percent of glycosylated hemoglobin] Mean ± Standard Deviation
Baseline	7.76 ± 0.65	7.79 ± 0.70
Change from Baseline at Week 54	-0.70 ± 0.80	-0.62 ± 0.91

Statistical Analysis 1 for Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Difference in least squares mean ^[3]	-0.11
Standard Deviation	± 0.74
95% Confidence Interval	( -0.29 to 0.06 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	The pre-specified non-inferiority margin was 0.4%; i.e., non-inferiority required that the upper boundary of the 95% confidence interval for the treatment difference (sitagliptin minus glipizide) to be less than 0.4%.
[3]	Other relevant estimation information:
	Based on analysis of covariance with terms for treatment, renal insufficiency stratum at Visit 4/Week -2 (moderate, or severe), prior diabetes pharmacotherapy (on or not on oral antihyperglycemic agent), and a covariate for baseline A1C.

2. Primary:

Percentage of Participants With Hypoglycemic Events [ Time Frame: Baseline up to 28 days following the last dose of study therapy ]

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3. Secondary:

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54 [ Time Frame: Baseline to Week 54 ]

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4. Secondary:

Change From Baseline in Body Weight at Week 54 [ Time Frame: Baseline to Week 54 ]

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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
No text entered.

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:	NCT00509262 History of Changes
Other Study ID Numbers:	MK-0431-063, 2007_549
Study First Received:	July 27, 2007
Results First Received:	February 28, 2012
Last Updated:	February 28, 2012
Health Authority:	United States: Food and Drug Administration

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