Type 2 Diabetes MellitusNCT01176656
Hypoglycemia: Physician and Patient Perspectives
An observational study of Type 2 Diabetes Mellitus and Hypoglycemia, run by AstraZeneca.
Trial summary
The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypoglycemia
- Type of treatment
- Pill or oral medicine
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with T2DM will be identified from a large U.S. administrative claims database using a claims-based algorithm for T2DM. Patients and their associated physicians will be recruited via mail into the survey portion of this study. Survey results will be linked to actual patient care using the claims records.
Who may be able to join
- T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug
- at least 1 HbA1c test recorded during the identification period
- continuous enrollment in the health plan for at least 12 months prior to survey date
Who cannot join
- Type 1 Diabetes Mellitus
- pregnancy or gestational diabetes
About this study
The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.
- Conditions
- Type 2 Diabetes Mellitus, Hypoglycemia
- Keywords
- Type 2 Diabetes Mellitus, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SU | T2DM patients with a prescription for a sulfonylurea but no insulin | |
| Antidiabetic without SU | T2DM patients with an oral antidiabetic drug other than an SU, and no insulin | |
| Insulin | T2DM patients using insulin, with or without other oral antidiabetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of hypoglycemia and impact of hypoglycemia
Measured: October 2009-October 2010
Secondary outcomes (2)
Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)
Measured: October 2009-October 2010
Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization
Measured: October 2009-October 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Setareh Williams, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176656
- Sponsor's protocol ID
- NIS-CUS-DUM-2010/1
- Status last verified
- Sep 2011
- First submitted
- 4 Aug 2010
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia: Physician and Patient Perspectives
- ClinicalTrials.gov ID
- NCT01176656
- Acronym / sponsor ID
- NIS-CUS-DUM-2010/1
- Conditions
- Type 2 Diabetes Mellitus, Hypoglycemia
- Keywords
- Type 2 Diabetes Mellitus, Hypoglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the burden of hypoglycemia and identify unmet need related to the management of hypoglycemia among Type 2Diabetes Mellitus (T2DM) patients on OADs and/or insulin. This is an observational study which will identify patients with T2DM in an administrative claims database and will link claims data with results of patient and physician surveys concerning hypoglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SU | – | –T2DM patients with a prescription for a sulfonylurea but no insulin |
| Antidiabetic without SU | – | –T2DM patients with an oral antidiabetic drug other than an SU, and no insulin |
| Insulin | – | –T2DM patients using insulin, with or without other oral antidiabetics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with T2DM will be identified from a large U.S. administrative claims database using a claims-based algorithm for T2DM. Patients and their associated physicians will be recruited via mail into the survey portion of this study. Survey results will be linked to actual patient care using the claims records.
Key inclusion criteria (3 listed)
- T2DM claims diagnosis (algorithm-based) with at least 2 pharmacy claims for an antidiabetic drug
- at least 1 HbA1c test recorded during the identification period
- continuous enrollment in the health plan for at least 12 months prior to survey date
Key exclusion criteria (2 listed)
- Type 1 Diabetes Mellitus
- pregnancy or gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prevalence of hypoglycemia and impact of hypoglycemia
Time frame: October 2009-October 2010
2 secondary outcomes
Patient Reported Outcomes of Hypoglycemia (including fear, awareness, behavioral modification and recovery from hypoglycemia)
Time frame: October 2009-October 2010
Treatment adherence and modification related to hypoglycemia, including health status, glycemic control and healthcare utilization
Time frame: October 2009-October 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
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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.
Setareh Williams, PhD study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Hypoglycemia, run by AstraZeneca.
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 2 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 13 Sep 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of hypoglycemia and impact of hypoglycemia (time frame: October 2009-October 2010). 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 13 Sep 2011.