The OBSTACLE Hypoglycemia Study (MK-0000-158)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1069 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All participants

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

Sulfonylurea

Intervention Type DRUG

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

Interventions

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Sulfonylurea

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No