DiabetesPhase 4NCT02061969
ADA Linagliptin in Long Term Care
A Phase 4 study testing linagliptin and insulin glargine in people with Diabetes, run by Emory University at 4 sites in United States.
Trial summary
This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- linagliptin and insulin glargine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Apr 2014to 10 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
- Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL
Who cannot join
- Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
- Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
- Recurrent severe hypoglycemia or hypoglycemic unawareness.
- Subjects with history of gastrointestinal obstruction or gastroparesis.
- Patients with acute or chronic pancreatitis or pancreatic cancer.
- Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 45 ml/min).
- Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
- Mental condition rendering the subject unable to understand the nature and scope of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Crestvew Nursing Home
Atlanta, Georgia, 30315
Budd Terrace Nursing Home
Atlanta, Georgia, 30322
Wesley Woods Nursing Home
Atlanta, Georgia, 30322
VA Nursing Home
Decatur, Georgia, 30033
About this study
Official title: A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
- Conditions
- Diabetes
- Being tested
- linagliptin, insulin glargine
- Keywords
- nursing home facility, long-term care facility, older patients, elderly patients, hyperglycemia, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linagliptinDrug
Also called Tradjenta
5mg linagliptin tablets
insulin glargineDrug
Also called Lantus
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine | Active comparator | Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. Receives: Drug: insulin glargine |
| linagliptin | Experimental | Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. Receives: Drug: linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Fasting Blood Glucose Level
The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
Measured: 6 months
Secondary outcomes (11)
HbA1c
HbA1c at 6 month
Measured: 6 months
Number of Hypoglycemic Events < 70mg/dl
total number of hypoglycemic events (<70 mg/dl)
Measured: over 6 months
Number of Hypoglycemic Events < 40mg/dl
total number of severe hypoglycemia (< 40 mg/dl).
Measured: over 6 months
Total Daily Dose of Insulin
Total daily dose of insulin (units)
Measured: over 6 months
Changes in Cognitive Function
Data on changes in cognitive function were not collected
Measured: over 6 months
Number of Participants With Acute Complications
Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).
Measured: over 6 months
Total Number of Emergency Room Visits
Total number of emergency room visits during the study period
Measured: 6 months
Total Number of Hospital Visits
Total number of hospital visits during the study period
Measured: 6 months
Total Number of Complications
Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality.
Measured: 6 months
Incidence of Acute Kidney Injury
Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy
Measured: over 6 months
Mortality
Mortality is defined as death occurring during admission at the LTC facility
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study start25 Apr 2014
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
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.
- More trials run by Emory 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Guillermo Umpierrez, MD, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061969
- Sponsor's protocol ID
- IRB00071545
- Other IDs
- IRB00071946
- Status last verified
- Jul 2018
- First submitted
- 11 Feb 2014
- Last updated
- 22 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Umpierrez GE, Cardona S, Chachkhiani D, Fayfman M, Saiyed S, Wang H, Vellanki P, Haw JS, Olson DE, Pasquel FJ, Johnson TM 2nd. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27.
PubMed 29289540
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02061969
- Acronym / sponsor ID
- IRB00071545
- Conditions
- Diabetes
- Keywords
- nursing home facility, long-term care facility, older patients, elderly patients, hyperglycemia, type 2 diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 25 Apr 2014
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 22 Aug 2018
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 study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine | Active comparator | Drug: insulin glargineInsulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. |
| linagliptin | Experimental | Drug: linagliptinOral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
- Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL
Key exclusion criteria (8 listed)
- Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
- Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
- Recurrent severe hypoglycemia or hypoglycemic unawareness.
- Subjects with history of gastrointestinal obstruction or gastroparesis.
- Patients with acute or chronic pancreatitis or pancreatic cancer.
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 |
|---|---|---|
| linagliptinAlso: Tradjenta5mg linagliptin tablets | Drug | linagliptin |
| insulin glargineAlso: Lantus | Drug | Insulin glargine |
Primary outcome
Mean Fasting Blood Glucose Level
Time frame: 6 months
The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
11 secondary outcomes
HbA1c
Time frame: 6 months
Number of Hypoglycemic Events < 70mg/dl
Time frame: over 6 months
Number of Hypoglycemic Events < 40mg/dl
Time frame: over 6 months
Total Daily Dose of Insulin
Time frame: over 6 months
Changes in Cognitive Function
Time frame: over 6 months
Number of Participants With Acute Complications
Time frame: over 6 months
Total Number of Emergency Room Visits
Time frame: 6 months
Total Number of Hospital Visits
Time frame: 6 months
Total Number of Complications
Time frame: 6 months
Incidence of Acute Kidney Injury
Time frame: over 6 months
Mortality
Time frame: over 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29289540Umpierrez GE, Cardona S, Chachkhiani D, Fayfman M, Saiyed S, Wang H, Vellanki P, Haw JS, Olson DE, Pasquel FJ, Johnson TM 2nd. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27.
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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 University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing linagliptin and insulin glargine in people with Diabetes, run by Emory University at 4 sites 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 2 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: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 22 Aug 2018). 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?
Mean Fasting Blood Glucose Level (time frame: 6 months). 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 NCT02061969, 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 22 Aug 2018.