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The OBSTACLE Hypoglycemia Study (MK-0000-158)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00907881
First received: May 21, 2009
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Drug: Sulfonylurea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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:
  • Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1069
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).
 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.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diabetic clinic patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907881

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00907881     History of Changes
Other Study ID Numbers: MK-0000-158, 2009_001
Study First Received: May 21, 2009
Results First Received: October 20, 2011
Last Updated: October 20, 2011
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013