The OBSTACLE Hypoglycemia Study (MK-0000-158)

NCT00907881 | Completed Results

• 2 other identifiers: 0000-1582009_001
• Study Type: observational
• Target: 1,069
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores

  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.

  Week 12

Secondary Outcomes (3)

• Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)

  Week 12

• Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)

  Week 12

• Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12

  Baseline and Week 12

Study Arms (1)

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

Interventions

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.

All participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic clinic patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Kalra S, Deepak MC, Narang P, Singh V, Uvaraj MG, Agrawal N. Usage pattern, glycemic improvement, hypoglycemia, and body mass index changes with sulfonylureas in real-life clinical practice: results from OBSTACLE Hypoglycemia Study. Diabetes Technol Ther. 2013 Feb;15(2):129-35. doi: 10.1089/dia.2012.0237. Epub 2013 Jan 5.

  PMID: 23289432 BACKGROUND

• Kalra S, Deepak MC, Narang P, Singh V, Maheshwari A. Correlation between measures of hypoglycemia and glycemic improvement in sulfonylurea treated patients with type 2 diabetes in India: results from the OBSTACLE hypoglycemia study. J Postgrad Med. 2014 Apr-Jun;60(2):151-5. doi: 10.4103/0022-3859.132322.

  PMID: 24823514 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 25, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 21, 2015
• Results First Posted: November 24, 2011

Record last verified: 2015-04