N/A
N=1,069
The OBSTACLE Hypoglycemia Study (MK-0000-158)
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00907881 ↗Enrolled (actual)
1,069
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcome: Primary: Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores — -0.1215 Correlation coefficient — p=0.0002
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sulfonylurea (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores |
-0.1215 | 0.0002 sig |
| SECONDARY Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) |
0.87; 1.12; 0.91; 0.87; 0.96; 1.18 | — |
| SECONDARY Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) |
-0.1654; -0.0756; -0.1636; -0.1034; -0.1222; -0.0984 | — |
| SECONDARY Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 |
0.0026 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00907881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.