The OBSTACLE Hypoglycemia Study (MK-0000-158)

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Sulfonylurea

• Registration Number: NCT00907881
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study First Submitted: 2009-05-21
• Study First Submitted QC: 2009-05-22
• Study First Posted: 2009-05-25
• Study Start: 2009-08
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-10-20
• Results First Submitted QC: 2011-10-20
• Results First Posted: 2011-11-24
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1069

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores	Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)	Week 12	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.
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)	Week 12	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.
Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12	Baseline and 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.