The OBSTACLE Hypoglycemia Study (MK-0000-158)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00907881

First received: May 21, 2009

Last updated: October 20, 2011

Last verified: October 2011

History of Changes

Results First Received: October 20, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Type 2 Diabetes
Intervention:	Drug: Sulfonylurea

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
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Reporting Groups

	Description
All Participants	Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).

Participant Flow: Overall Study

	All Participants
STARTED	1069
COMPLETED	984
NOT COMPLETED	85
Lost to Follow-up	59
Noncompliance	5
Withdrawal by Subject	5
Protocol Violation	1
Missing discontinuation information	15

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).

Baseline Measures

	All Participants
Number of Participants [units: participants]	1069
Age ^[1] [units: years] Mean ± Standard Deviation	52.21 ± 10.70
Gender, Customized [units: participants]
Female	472
Male	589
Missing	8
Region of Enrollment [units: participants]
India	1069

[1]	Age was missing for 1 participant; therefore, the population for age included 1068 participants.

Outcome Measures

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1. Primary:

Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores [ Time Frame: Week 12 ]

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Measure Type	Primary
Measure Title	Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores
Measure Description	Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
Time Frame	Week 12
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.
Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.

Reporting Groups

	Description
All Participants	Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).

Measured Values

	All Participants
Number of Participants Analyzed [units: participants]	950
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores [units: Correlation coefficient] Number ( 95% Confidence Interval )	-0.1215 ( -0.1836 to -0.0583 )

Statistical Analysis 1 for Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores

Groups ^[1]	All Participants
Method ^[2]	Regression, Linear
P Value ^[3]	0.0002

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
	Pearson correlation coefficient
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Secondary:

Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) [ Time Frame: Week 12 ]

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3. Secondary:

Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) [ Time Frame: Week 12 ]

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4. Secondary:

Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 [ Time Frame: Baseline and Week 12 ]

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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 study 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 study 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:	NCT00907881 History of Changes
Other Study ID Numbers:	MK-0000-158, 2009_001
Study First Received:	May 21, 2009
Results First Received:	October 20, 2011
Last Updated:	October 20, 2011
Health Authority:	India: Ministry of Health

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