The OBSTACLE Hypoglycemia Study (MK-0000-158)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Drug: Sulfonylurea

Study type: Observational

Funder types: Industry

Identifiers

NCT00907881

0000-158

2009_001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,069 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,069 participants in 1 patient group

All participants

Description:

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

Treatment:

Drug: Sulfonylurea