Clinical trial NCT00907881: The OBSTACLE Hypoglycemia Study (MK-0000-158)
Official title: Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-05-25
Enrollment: 1069
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic clinic patients

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 oral hypoglycemic agents.

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 physicians based on the clinical needs of the participating patients.

Eligibility 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

Primary outcomes:
measure: Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores
timeFrame: Week 12
Secondary outcomes:
measure: Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
timeFrame: Week 12
measure: Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
timeFrame: Week 12
measure: Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kalra S, Deepak MC, Narang P, Singh V, Uvaraj MG, Agrawal N. Usage pattern, glycemic improvement, hypoglycemia, and body mass index changes with sulfonylureas in real-life clinical practice: results from OBSTACLE Hypoglycemia Study. Diabetes Technol Ther. 2013 Feb;15(2):129-35. doi: 10.1089/dia.2012.0237. Epub 2013 Jan 5.
citation: Kalra S, Deepak MC, Narang P, Singh V, Maheshwari A. Correlation between measures of hypoglycemia and glycemic improvement in sulfonylurea treated patients with type 2 diabetes in India: results from the OBSTACLE hypoglycemia study. J Postgrad Med. 2014 Apr-Jun;60(2):151-5. doi: 10.4103/0022-3859.132322.