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Completed

NCT Number: NCT00907881

The OBSTACLE Hypoglycemia Study (MK-0000-158)

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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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulfonylurea

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 25, 2009
Registry last updated
Apr 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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