Type 2 Diabetes MellitusNEEDSNCT01285076
Evaluation of Low Blood Sugar Events in Participants With Diabetes (MK-0431-401)
An observational study of Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC at 1 site in Taiwan.
Trial summary
This is a multi-center, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus (DM) 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?
- Other: Retrospective chart review; one participant encounter visit.
- How many people
- 834 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jan 2011to 27 Dec 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 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
Who may be able to join
- Participants diagnosed with Type 2 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, neurologist, or family practice doctor 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)
This is a multi-center, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, neurologist, or family practice doctor for at least 6 months prior to Study Enrollment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Other: Retrospective chart review; one participant encounter visit.
- 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.
Other: Retrospective chart review; one participant encounter visit.Other
Participants will be selected based on medical record review in the office of their treating cardiologist, nephrologist, neurologist, or family practice doctor. Participants will have one encounter visit to fill out questionnaires and have a blood draw and recording of weight, blood pressure and waist circumference.
| Study group | Role | What they receive |
|---|---|---|
| All Enrolled Participants | Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor. Receives: Other: Other: Retrospective chart review; one participant encounter visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%
HbA1c is measured as a percent.
Measured: 6 months
Number of Participants With Hypoglycemic Episodes
Participants self-reported hypoglycemic (low blood sugar) episodes.
Measured: 6 months
Secondary outcomes (8)
Score on the Quality of Life (EQ-5D) Questionnaire
The EQ-5D is a standardised instrument for use as a measure of general health outcome. The EQ-5D contains 5 items to be answered using a 3-point Likert scale plus a Visual Analog Scale (VAS). The EQ-5D covers the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Total possible score ranges from 0 (worst) to 100 (best).
Measured: 1 day (the day of the encounter visit)
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)
TSQM is a treatment satisfaction questionnaire. The questionnaire consisted of the following dimensions: side effects (4 items), effectiveness (3 items), convenience (3 items) and global satisfaction scale (3 items). Each dimension was measured as a score on a scale. Total possible score ranges from 0 to 100 with a lower score representing a better quality of life.
Measured: 1 day (the day of the encounter visit)
Number of Adherence Days on the Self-reported Adherence Questionnaire
The self-report adherence questionnaire contains the following items: diabetic diet, exercise, and no missed medication doses during the past week. Total possible score ranges from 0 days (complete non-adherence) to 7 days (complete adherence).
Measured: 7 days (during the 7-day period prior to the encounter visit)
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire
The experience of low blood sugar questionnaire was developed by the Sponsor to measure the participant's experience of hypoglycemia during the previous 6 months. The questionnaire contains 6 items answered by yes/no or by using a 5-point Likert scale.
Measured: 6 months (during the 6-month period prior to the encounter visit)
Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II
This questionnaire measures a diabetic participant's fear of hypoglycemia. Items were answered using a 5-point Likert scale; range: 1 (never) to 5 (very often). Total possible scores ranged from 18 (least) to 90 (most).
Measured: 6 months (during the 6-month period prior to the encounter visit)
Experience of Weight Gain Questionnaire
Participants completed a questionnaire regarding weight (wt) gain during the previous year (measured in kilograms[kg]). The questionnaire contained 4 parts: wt gain, subjective severity of wt gain, bothered by wt gain, and difficulty maintaining wt. Percentages presented below are rounded.
Measured: 1 year (during the 12-month period prior to the encounter visit)
Fear of Weight Gain Questionnaire
Participants completed a questionnaire regarding their fear of wt gain during the previous year. The questionnaire contained 3 parts: worried about wt gain, worried that diabetic treatment causes wt gain (worried diab tx and wt gain), and worried about not being able to stabilize wt (worried not stabilize wt).
Measured: 1 year (during the 12-month period prior to the encounter visit)
Self-reported Barrier Questionnaire
The self-report barrier questionnaire contains 4 items: difficulty filling prescriptions, unsure about physician instructions, unable to follow plan for diabetes, and bothered by adverse effects during the prior month.
Measured: 30 days (during the 30-day period prior to the encounter visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study start10 Jan 2011
- Primary completion27 Dec 2012
- Study completion27 Dec 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
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285076
- Sponsor's protocol ID
- 0431-401
- Acronym
- NEEDS
- Status last verified
- Apr 2024
- First submitted
- 26 Jan 2011
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects (NEEDS Study)
- ClinicalTrials.gov ID
- NCT01285076
- Acronym / sponsor ID
- NEEDS / 0431-401
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2011 (actual)
- Primary completion
- 27 Dec 2012 (actual)
- Study completion
- 27 Dec 2012 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Posted 24 Mar 2014
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 multi-center, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with Type 2 diabetes mellitus (DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, neurologist, or family practice doctor for at least 6 months prior to Study Enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Enrolled Participants | – | Other: Other: Retrospective chart review; one participant encounter visit.Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, 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 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
Key inclusion criteria (6 listed)
- Participants diagnosed with Type 2 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, neurologist, or family practice doctor 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 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 |
|---|---|---|
| Other: Retrospective chart review; one participant encounter visit.Participants will be selected based on medical record review in the office of their treating cardiologist, nephrologist, neurologist, or family practice doctor. Participants will have one encounter visit to fill out questionnaires and have a blood draw and recording of weight, blood pressure and waist circumference. | Other | All Enrolled Participants |
Primary outcome
Number of Participants Achieving Hemoglobin A1C (HbA1C) <7%
Time frame: 6 months
HbA1c is measured as a percent.
Number of Participants With Hypoglycemic Episodes
Time frame: 6 months
Participants self-reported hypoglycemic (low blood sugar) episodes.
8 secondary outcomes
Score on the Quality of Life (EQ-5D) Questionnaire
Time frame: 1 day (the day of the encounter visit)
Score on the Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: 1 day (the day of the encounter visit)
Number of Adherence Days on the Self-reported Adherence Questionnaire
Time frame: 7 days (during the 7-day period prior to the encounter visit)
Experience of Low Blood Sugar (Hypoglycemia) Questionnaire
Time frame: 6 months (during the 6-month period prior to the encounter visit)
Score on the Worry Scale of Hypoglycemia Fear Survey (HFS) II
Time frame: 6 months (during the 6-month period prior to the encounter visit)
Experience of Weight Gain Questionnaire
Time frame: 1 year (during the 12-month period prior to the encounter visit)
Fear of Weight Gain Questionnaire
Time frame: 1 year (during the 12-month period prior to the encounter visit)
Self-reported Barrier Questionnaire
Time frame: 30 days (during the 30-day period prior to the encounter visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC at 1 site in Taiwan.
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 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mar 2014). 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 Achieving Hemoglobin A1C (HbA1C) <7% (time frame: 6 months). The study lists 2 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 21 May 2024.