The OBSTACLE Hypoglycemia Study (MK-0000-158)

Study Overview
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Brief Summary
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This study will assess the correlation between glycemic control and the hypoglycemia symptom score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an ongoing regime of oral hypoglycemic agents.

Detailed Description
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Patients will be evaluated for participation in the study during their usual visit to participating diabetes care clinics. Addition of sulfonylurea will be an unbiased decision of the participating physicians based on the clinical needs of the participating patients.

Official Title
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Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Sulfonylurea


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 2 Diabetes, of either gender and aged between 18-75 years Patients being considered for addition of Sulfonylurea on background of at least one other oral hypoglycemic agent, on a usual visit (screening cum enrolment visit), as per the clinical situation judged by participating physician Willing to comply with study requirements Exclusion Criteria: Patients with type 1 Diabetes or gestational Diabetes Patients currently on insulin therapy or have received Insulin in last 6 months Patients currently on Sulfonylurea therapy or have received Sulfonylureas in last 6 months Patients currently on Meglitinides therapy or have received Meglitinides in last 6 months Patients initiated on Sulfonylurea monotherapy Patient on DPP-4 inhibitors, either as monotherapy or as combination therapy Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. Patients for whom it would be impossible to complete the questionnaire for whatever reason, in any feasible form Patients who are already participating in a clinical trial or other clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s). | Drug: Sulfonylurea<br>* The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores | 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | 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. | Week 12 | 
| Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | 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. | Week 12 | 
| Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at 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. | Baseline and Week 12 |