The OBSTACLE Hypoglycemia Study (MK-0000-158)

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

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