The OBSTACLE Hypoglycemia Study (MK-0000-158)

An observational study of Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Sulfonylurea
Type of treatment: Pill or oral medicine
How many people: 1,069 participants
Where: No sites listed yet
Study dates: Aug 2009to May 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Diabetic clinic patients

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

About this study

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

Read the 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.

Conditions: Type 2 Diabetes
Being tested: Sulfonylurea
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00907881
Study group	Role	What they receive
All participants		Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s). Receives: Drug: Sulfonylurea

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 12

Secondary outcomes (3)

Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
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.
Measured: Week 12
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
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.
Measured: Week 12
Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at 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.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009May 2010

First posted25 May 2009 (estimated)
Study startAug 2009
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,069 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00907881
Sponsor's protocol ID: 0000-158
Other IDs: 2009_001
Status last verified: Apr 2015
First submitted: 21 May 2009
Last updated: 21 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23289432
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.
PubMed 24823514

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Observational Study to Assess Correlation Between Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes Treated With Sulfonylurea
ClinicalTrials.gov ID: NCT00907881
Acronym / sponsor ID: 0000-158
Conditions: Type 2 Diabetes
Study type: Observational
Recruitment status: Completed
Enrolment: 1,069 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 25 May 2009 (estimated)
Results: Posted 24 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All participants	–	Drug: SulfonylureaParticipants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Diabetic clinic patients

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SulfonylureaThe dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.	Drug	All participants

Primary outcome

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.

3 secondary outcomes

Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters)
Time frame: Week 12
Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters)
Time frame: Week 12
Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 24 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	1,069	984

Primary outcome: Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores

Time frame: Week 12. Number (95% Confidence Interval). Unit: Correlation coefficient

Measure	All Participants n = 950
Value	-0.1215 (1.90)

All Participants: p = 0.0002, Regression, Linear

Population analysed: Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 1,069 (0%)	492 of 1,069 (46%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23289432Kalra 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.
Derived from this study: PubMed 24823514Kalra 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.

Related trials for Type 2 Diabetes

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Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00907881, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.