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The OBSTACLE Hypoglycemia Study (MK-0000-158)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00907881
Recruitment Status : Completed
First Posted : May 25, 2009
Results First Posted : November 24, 2011
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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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.

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: Sulfonylurea

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 Design
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Study Type : Observational
Actual Enrollment : 1069 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores [ Time Frame: 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 :
  1. Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) [ Time Frame: 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.

  2. Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) [ Time Frame: 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.

  3. Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907881


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00907881    
Other Study ID Numbers: 0000-158
2009_001
First Posted: May 25, 2009    Key Record Dates
Results First Posted: November 24, 2011
Last Update Posted: April 21, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Hypoglycemia
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases