Type 2 Diabetes MellitusPhase 4NCT02029846
Glycemia in Diabetic Elders Trial
A Phase 4 study testing Standard Treatment and Incretin-Based Treatment in people with Type 2 Diabetes Mellitus, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Standard Treatment and Incretin-Based Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Feb 2017
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Type 2 diabetics diagnosed for at least 6 months
- Patients ages ≥ 65 years and older
- Active patients in the Bay West Endocrinology practice
- Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
- Eligible for randomization to either treatment group
- Patients willing to follow either treatment arm including regimen using one or more injectables
- Patients to have an English Reading Level of Grade 6 or above
- Patients residing at home
Who cannot join
- Unwilling to use a regimen that may contain using one or more injections
- Using short acting insulin prior to the study
- Using GLP-1 in past 10 weeks
- History of hypoglycemia unawareness or episodes needing emergency intervention
- End-stage renal disease
- Dementia
- Blindness
- Terminal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Bay West Endocrinology Associates
Baltimore, Maryland, 21204
About this study
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Standard Treatment, Incretin-Based Treatment
- 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.
Standard TreatmentDrug
Also called insulin, metformin, sulfonylureas, TZDs
traditional drugs only
Incretin-Based TreatmentDrug
Also called GLP-1 analogues and receptor agonists,, DPP-4 inhibitors,, amylin analogues
incretin-based drugs
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Active comparator | A regimen with traditional drugs only Receives: Drug: Standard Treatment |
| Incretin-based Treatment | Experimental | A regimen including incretin-based drugs Receives: Drug: Incretin-Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve Glycemic Target (HbA1c <7.5%).
Data not analyzed due to n=1 each arm.
Measured: 6 months
Secondary outcomes (1)
Overall Hypoglycemia Measured by Glucose Meter
Data not analyzed due to n=1 each arm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: No sufficient numbers of eligible participants
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 Johns Hopkins UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsin-Chieh Yeh, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029846
- Sponsor's protocol ID
- NA_00052707
- Status last verified
- Feb 2018
- First submitted
- 6 Jan 2014
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemia in Diabetic Elders Trial
- ClinicalTrials.gov ID
- NCT02029846
- Acronym / sponsor ID
- NA_00052707
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No sufficient numbers of eligible participants
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 25 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Active comparator | Drug: Standard TreatmentA regimen with traditional drugs only |
| Incretin-based Treatment | Experimental | Drug: Incretin-Based TreatmentA regimen including incretin-based drugs |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetics diagnosed for at least 6 months
- Patients ages ≥ 65 years and older
- Active patients in the Bay West Endocrinology practice
- Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
- Eligible for randomization to either treatment group
Key exclusion criteria (8 listed)
- Unwilling to use a regimen that may contain using one or more injections
- Using short acting insulin prior to the study
- Using GLP-1 in past 10 weeks
- History of hypoglycemia unawareness or episodes needing emergency intervention
- End-stage renal disease
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 |
|---|---|---|
| Standard TreatmentAlso: insulin, metformin, sulfonylureas, TZDstraditional drugs only | Drug | Standard Treatment |
| Incretin-Based TreatmentAlso: GLP-1 analogues and receptor agonists,, DPP-4 inhibitors,, amylin analoguesincretin-based drugs | Drug | Incretin-based Treatment |
Primary outcome
Time to Achieve Glycemic Target (HbA1c <7.5%).
Time frame: 6 months
Data not analyzed due to n=1 each arm.
1 secondary outcome
Overall Hypoglycemia Measured by Glucose Meter
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
Hsin-Chieh Yeh, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard Treatment and Incretin-Based Treatment in people with Type 2 Diabetes Mellitus, run by Johns Hopkins University at 1 site in United States.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Apr 2023. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2017). 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?
Time to Achieve Glycemic Target (HbA1c <7.5%). (time frame: 6 months). 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 18 Apr 2023.