The OBSTACLE Hypoglycemia Study (MK-0000-158)
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|ClinicalTrials.gov Identifier: NCT00907881|
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : November 24, 2011
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes||Drug: Sulfonylurea|
|Study Type :||Observational|
|Actual Enrollment :||1069 participants|
|Official Title:||Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).
The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.
- Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores [ Time Frame: Week 12 ]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.
- Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) [ Time Frame: Week 12 ]Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12.
- Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) [ Time Frame: Week 12 ]Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa.
- Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 [ Time Frame: Baseline and Week 12 ]Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907881
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|