Type 2 Diabetes MellitusPhase 4NCT03660553
Simplified Insulin Regimen for the Elderly
A Phase 4 study testing Insulin Glargine, Insulin Aspart and Insulin Lispro in people with Type 2 Diabetes Mellitus, run by University of Miami at 1 site in United States.
Trial summary
Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each… 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?
- Insulin Glargine, Insulin Aspart and Insulin Lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 30 Jun 2022
- 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
- -Age >65 years
Who cannot join
- Unable to provide informed consent
- Enrollment in another research study
- History of hypoglycemia unawareness
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes
Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age >65 years) with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Insulin Glargine, Insulin Aspart, Insulin Lispro
- Keywords
- Diabetes, Elderly, Insulin treatment, Quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
0.40 units/kg body weight
Insulin GlargineDrug
0.20 units/kg body weight
Insulin AspartDrug
0.20 units/kg body weight
Insulin LisproDrug
0.20 units/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Multiple Subcutaneous Injection (MSI) | Active comparator | MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. Receives: Drug: Insulin Glargine; Drug: Insulin Aspart; Drug: Insulin Lispro |
| Basal Insulin (BI) | Experimental | BI group will receive only one injection of insulin glargine in the morning. Receives: Drug: Insulin Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
Measured: 6 months
Secondary outcomes (2)
Incidence of Any Hypoglycemia
Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups
Measured: 6 months
Incidence of Severe Hypoglycemia
Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups.
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 posted6 Sep 2018
- Study start10 Oct 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: PI left University of Miami
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.
- 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
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajesh Garg, University of Miami
- Investigators
- Rajesh Garg, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660553
- Sponsor's protocol ID
- 20180541
- Status last verified
- Nov 2023
- First submitted
- 4 Sep 2018
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simplified Insulin Regimen on Glycemic Control and Quality of Life in an Elderly Population With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03660553
- Acronym / sponsor ID
- 20180541
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Elderly, Insulin treatment, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left University of Miami
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 12 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age >65 years) with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Subcutaneous Injection (MSI) | Active comparator | Drug: Insulin Glargine, Drug: Insulin Aspart, Drug: Insulin LisproMSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. |
| Basal Insulin (BI) | Experimental | Drug: Insulin GlargineBI group will receive only one injection of insulin glargine in the morning. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- -Age >65 years
Key exclusion criteria (5 listed)
- Unable to provide informed consent
- Enrollment in another research study
- History of hypoglycemia unawareness
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Insulin Glargine0.40 units/kg body weight | Drug | Basal Insulin (BI) |
| Insulin Glargine0.20 units/kg body weight | Drug | Multiple Subcutaneous Injection (MSI) |
| Insulin Aspart0.20 units/kg body weight | Drug | Multiple Subcutaneous Injection (MSI) |
| Insulin Lispro0.20 units/kg body weight | Drug | Multiple Subcutaneous Injection (MSI) |
Primary outcome
Hemoglobin A1c (HbA1c)
Time frame: 6 months
The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group
2 secondary outcomes
Incidence of Any Hypoglycemia
Time frame: 6 months
Incidence of Severe Hypoglycemia
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 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rajesh Garg, MD principal investigator
University of Miami
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 Insulin Glargine, Insulin Aspart and Insulin Lispro in people with Type 2 Diabetes Mellitus, run by University of Miami 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 1 inclusion and 5 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 12 Dec 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 12 Dec 2023). 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?
Hemoglobin A1c (HbA1c) (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 12 Dec 2023.