DiabetesPhase 4DMElderlyNCT01131052
Diabetes in the Elderly: Prospective Study
A Phase 4 study testing Insulin Glargine, Insulin and Insulin glulisine in people with Diabetes and Hyperglycemia, run by Guillermo Umpierrez at 1 site in United States.
Trial summary
Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes, Hyperglycemia
- What is being tested?
- Insulin Glargine, Insulin and Insulin glulisine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 2013
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females > 60 years of age.
- Blood glucose > 150 mg/dl and A1C > 7.5%.
- A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin).
- Patients admitted for non-cardiac elective or emergency surgery or trauma.
Who cannot join
- Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diabetes Care in Nursing Home Residents: A Randomized Controlled Study
Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing.
Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. In addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes.
Read more
There are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes.
Accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with T2DM.
- Conditions
- Diabetes, Hyperglycemia
- Being tested
- Insulin Glargine, Insulin, Insulin glulisine
- Keywords
- elderly populations, diabetes
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin GlargineDrug
Also called Lantus
glargine once a day
InsulinDrug
Also called Novolin R
sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
Insulin glulisineDrug
Also called Apridra
glulisine given as needed before meals
| Study group | Role | What they receive |
|---|---|---|
| BASAL PLUS | Active comparator | Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed Receives: Drug: Insulin Glargine; Drug: Insulin glulisine |
| sliding scale regular insulin (SSRI) | Active comparator | Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
Mean weekly blood glucose concentration less than 70 mg/dL at 3 months
Measured: 3 months
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL
Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
Measured: 3 months
Mean of Weekly Fasting Blood Glucose Concentration
Mean weekly blood glucose concentration at 3 months
Measured: 3 months
Secondary outcomes (5)
Mean Blood Glucose Concentration
Mean blood glucose concentration at baseline
Measured: Baseline
Mean of Glycosylated Hemoglobin (hbA1c)
Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.
Measured: Baseline
Mean of Daily Blood Glucose Concentration
Mean of daily blood glucose concentration at baseline
Measured: Baseline
Mean of Glycosylated Hemoglobin (hbA1c)
Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.
Measured: 3 months
Mean of Glycosylated Hemoglobin (hbA1c)
Mean glycosylated hemoglobin (hbA1c) at baseline. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.
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 posted26 May 2010 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guillermo Umpierrez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131052
- Sponsor's protocol ID
- IRB00038789
- Acronym
- DMElderly
- Status last verified
- Dec 2014
- First submitted
- 19 May 2010
- Last updated
- 31 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pasquel FJ, Powell W, Peng L, Johnson TM, Sadeghi-Yarandi S, Newton C, Smiley D, Toyoshima MT, Aram P, Umpierrez GE. A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities. BMJ Open Diabetes Res Care. 2015 Aug 28;3(1):e000104. doi: 10.1136/bmjdrc-2015-000104. eCollection 2015.
PubMed 26336609
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Care in Nursing Home Residents: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01131052
- Acronym / sponsor ID
- DMElderly / IRB00038789
- Conditions
- Diabetes, Hyperglycemia
- Keywords
- elderly populations, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Guillermo UmpierrezUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 May 2010 (estimated)
- Results
- Posted 31 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing.
Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. In addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes.
There are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes.
Accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with T2DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BASAL PLUS | Active comparator | Drug: Insulin Glargine, Drug: Insulin glulisineDiabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed |
| sliding scale regular insulin (SSRI) | Active comparator | Drug: InsulinDiabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females > 60 years of age.
- Blood glucose > 150 mg/dl and A1C > 7.5%.
- A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin).
- Patients admitted for non-cardiac elective or emergency surgery or trauma.
Key exclusion criteria (4 listed)
- Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
- Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
- Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
- Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism
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 GlargineAlso: Lantusglargine once a day | Drug | BASAL PLUS |
| InsulinAlso: Novolin Rsliding scale regular insulin (SSRI) given before meals and at bedtime as needed | Drug | sliding scale regular insulin (SSRI) |
| Insulin glulisineAlso: Apridraglulisine given as needed before meals | Drug | BASAL PLUS |
Primary outcome
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
Time frame: 3 months
Mean weekly blood glucose concentration less than 70 mg/dL at 3 months
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL
Time frame: 3 months
Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
Mean of Weekly Fasting Blood Glucose Concentration
Time frame: 3 months
Mean weekly blood glucose concentration at 3 months
5 secondary outcomes
Mean Blood Glucose Concentration
Time frame: Baseline
Mean of Glycosylated Hemoglobin (hbA1c)
Time frame: Baseline
Mean of Daily Blood Glucose Concentration
Time frame: Baseline
Mean of Glycosylated Hemoglobin (hbA1c)
Time frame: 3 months
Mean of Glycosylated Hemoglobin (hbA1c)
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 31 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26336609Pasquel FJ, Powell W, Peng L, Johnson TM, Sadeghi-Yarandi S, Newton C, Smiley D, Toyoshima MT, Aram P, Umpierrez GE. A randomized controlled trial comparing treatment with oral agents and basal insulin in elderly patients with type 2 diabetes in long-term care facilities. BMJ Open Diabetes Res Care. 2015 Aug 28;3(1):e000104. doi: 10.1136/bmjdrc-2015-000104. eCollection 2015.
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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.
Guillermo Umpierrez, MD principal investigator
Emory SOM
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 and Insulin glulisine in people with Diabetes and Hyperglycemia, run by Guillermo Umpierrez 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 4 inclusion and 4 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 31 Dec 2014. 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 31 Dec 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?
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT01131052, which also lists 1 linked publication.
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 31 Dec 2014.