Status:
COMPLETED
The OBSTACLE Hypoglycemia Study (MK-0000-158)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Brief 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 o...
Detailed 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 ph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
1069 Patients enrolled
Trial Details
Trial ID
NCT00907881
Start Date
August 1 2009
End Date
May 1 2010
Last Update
April 21 2015
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