The OBSTACLE Hypoglycemia Study (MK-0000-158)

Type 2 Diabetes Clinical Trial

Official title:

Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907881
• Other study ID #: 0000-158
• Secondary ID: 2009_001
• Status: Completed
• Phase: N/A
• First received: May 21, 2009
• Last updated: April 1, 2015
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1069
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypoglycemia
• Type 2 Diabetes

Intervention

Drug:
• Sulfonylurea
The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores	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.	Week 12	No
Secondary	Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)	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.	Week 12	No
Secondary	Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)	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.	Week 12	No
Secondary	Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at 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.	Baseline and Week 12	No