Type 2 Diabetes MellitusNEEDSNCT01278485
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-402)
An observational study of Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.
Trial summary
This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sulphonylurea and Metformn
- How many people
- 726 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jun 2012
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ merformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
Who may be able to join
- Participants diagnosed with type 2 diabetes mellitus (DM).
- Participants at least 30 years of age at time of type 2 DM diagnosis.
- Participants treated with SU monotherapy or SU + MF combination therapy for at least 6 months prior to enrollment.
- Participants receiving diabetes care from a cardiologist, nephrologist or family practitioner for at least 6 months.
- Participants with a clinical record in the health care center.
- Participants in whose medical records a minimum core data set can be found; core data defined as: age, gender, duration of diabetes/age at diagnosis, all glucose-lowering medications (branded and generic names, dosage, dosing frequency, starting and stopping dates) since the start of all antihyperglycemic medications.
Who cannot join
- Participants with Type 1 DM.
- Participants who are pregnant or with gestational DM.
- Participants receiving any anti-diabetic treatment from an endocrinologist/diabetologist in the previous 6 months.
- Participants requiring daily concomitant usage of insulin.
- Participants receiving any other oral diabetes medications other than SU or SU + MF.
- Participants who are already participating in a clinical trial or other clinical study.
- Participants for whom it would be impossible to complete the questionnaire.
About this study
Official title: Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects
This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment.
The purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM participants treated in cardiology, nephrology and family practice settings.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sulphonylurea, Metformn
- Keywords
- Diabetes complications
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulphonylureaDrug
SU administered according to usual practice.
MetformnDrug
Metformin administered according to usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Sulphonylurea (SU) Monotherapy or SU + Metformin | Participants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor. Receives: Drug: Sulphonylurea; Drug: Metformn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment
The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.
Measured: Up to 6 Months Prior to Enrollment
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.
Measured: Up to 6 Months Prior to Enrollment
Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment
Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
Measured: Day of Enrollment
Secondary outcomes (7)
Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment
The EQ-5D is a questionnaire that assesses participant quality of life in 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has 3 levels: no problems, some problems, extreme problems for which participants are asked to self-rate their experience. The EQ-5D total score ranges from -0.171 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
Measured: Day of Enrollment
Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment
Participant health status was self-reported in 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and was analyzed by using visual analog scale (VAS) which records participant responses on a scale of 0 (poor health) to 100 (excellent health).
Measured: Day of Enrollment
Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment
The TSQM is a treatment satisfaction questionnaire containing 14 items covering the following dimensions: side effects, effectiveness, convenience, and global satisfaction. Participants were asked to respond in a yes or no fashion, or by using a 5- or 7-point Likert scale. The score for each dimension ranges from 0 to 100, with a higher score expressing a better quality of life.
Measured: Day of Enrollment
Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment
The self-reported adherence and barriers questionnaire to measure treatment compliance asked participants to rate their responses to 5 questions: How often do you take your diabetes medicines exactly as your healthcare provider prescribes them?; During the past 4 weeks, how often were you unsure about some of the things your doctor suggested you do for your diabetes?; During the past 4 weeks, how often were you unable to do what was necessary to follow your doctor's treatment plans for your diabetes?; During the past 4 weeks, how often were you bothered by side effects from your medicines?; and During the past 4 weeks, how often did you have problems getting your prescriptions filled? Participants responded using a scale of 1 to 5, where 1=always, 2=usually, 3=sometimes, 4=rarely, and 5=never.
Measured: Day of Enrollment
Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment
Fear about hypoglycemia during 6 months prior to enrollment was evaluated using the Worry Scale of the HFS II. Responses to the 18-item questionnaire were recorded on a 0 to 4 scale, with 0=never, 1=rarely, 2=sometimes, 3=often, 4=almost always. The total score ranges from 0 to 72, with higher scores indicating increasing fear of hypoglycemia.
Measured: Day of Enrollment
Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment
Participants were asked to rate their weight change experience in the 12 months prior to enrollment as: weight increased, weight decreased, or weight remained stable.
Measured: Up to 12 Months Prior to Enrollment
Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment
On the day of enrollment, participants were asked to rate their fear of gaining weight in the 12 months prior to enrollment using a self-administered questionnaire. The questionnaire elicited responses to 3 statements (I worry about gaining weight; I worry that my diabetic treatment makes me gain weight; and I worry about not being able to stabilize my weight) and relied on a scale of 0 to 4, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=almost always.
Measured: Up to 12 Months Prior to Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
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.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Retrospective
- Enrolment
- 726 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278485
- Sponsor's protocol ID
- 0431-402
- Acronym
- NEEDS
- Status last verified
- Jul 2015
- First submitted
- 13 Jan 2011
- Last updated
- 28 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects
- ClinicalTrials.gov ID
- NCT01278485
- Acronym / sponsor ID
- NEEDS / 0431-402
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 726 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Posted 26 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment.
The purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM participants treated in cardiology, nephrology and family practice settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulphonylurea (SU) Monotherapy or SU + Metformin | – | Drug: Sulphonylurea, Drug: MetformnParticipants with Type 2 diabetes that have been treated with SU monotherapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ merformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
Key inclusion criteria (6 listed)
- Participants diagnosed with type 2 diabetes mellitus (DM).
- Participants at least 30 years of age at time of type 2 DM diagnosis.
- Participants treated with SU monotherapy or SU + MF combination therapy for at least 6 months prior to enrollment.
- Participants receiving diabetes care from a cardiologist, nephrologist or family practitioner for at least 6 months.
- Participants with a clinical record in the health care center.
Key exclusion criteria (7 listed)
- Participants with Type 1 DM.
- Participants who are pregnant or with gestational DM.
- Participants receiving any anti-diabetic treatment from an endocrinologist/diabetologist in the previous 6 months.
- Participants requiring daily concomitant usage of insulin.
- Participants receiving any other oral diabetes medications other than SU or SU + MF.
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 |
|---|---|---|
| SulphonylureaSU administered according to usual practice. | Drug | Sulphonylurea (SU) Monotherapy or SU + Metformin |
| MetformnMetformin administered according to usual practice. | Drug | Sulphonylurea (SU) Monotherapy or SU + Metformin |
Primary outcome
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment
Time frame: Up to 6 Months Prior to Enrollment
The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe.
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
Time frame: Up to 6 Months Prior to Enrollment
At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category.
Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment
Time frame: Day of Enrollment
Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
7 secondary outcomes
Participant Mean Score on the EuroQol-5 Dimension (EQ-5D) Quality-of-Life Questionnaire At the Time of Enrollment
Time frame: Day of Enrollment
Participant Mean Score on the EuroQol Visual Analog Scale (EQ-VAS) Quality-of-Life Questionnaire At the Time of Enrollment
Time frame: Day of Enrollment
Participant Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) At the Time of Enrollment
Time frame: Day of Enrollment
Participant Mean Score on the Self-Reported Adherence and Barriers Questionnaire At the Time of Enrollment
Time frame: Day of Enrollment
Participant Mean Score on the Worry Scale of Hypoglycemia Fear Survey (HFS II) At the Time of Enrollment
Time frame: Day of Enrollment
Number of Participants Experiencing a Change in Body Weight in the 12 Months Prior to Enrollment
Time frame: Up to 12 Months Prior to Enrollment
Number of Participants Reporting Body Weight Fears in the 12 Months Prior to Enrollment
Time frame: Up to 12 Months Prior to Enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, 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 6 inclusion and 7 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 28 Jul 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 26 Aug 2013). 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?
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment (time frame: Up to 6 Months Prior to Enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2015.