Type 2 DiabetesPhase 4NCT02004366
Linagliptin Inpatient Trial
A Phase 4 study testing Linagliptin, Basal Bolus and Linagliptin + 50% Glargine dose on discharge in people with Type 2 Diabetes, run by Emory University at 5 sites in United States.
Trial summary
This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Linagliptin, Basal Bolus and Linagliptin + 50% Glargine dose on discharge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or female surgical non-ICU patients ages between18 and 80 years
- A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
- Subjects with a BG >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones)
Who cannot join
- Age < 18 or > 80 years.
- Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
- Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
- Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
- Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Show all 14Show fewer
- Patients with clinically relevant pancreatic or gallbladder disease.
- Patients with previous history of pancreatitis
- Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
- Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Pregnancy or breast feeding at time of enrollment into the study.
- Patients who received supplemental sliding scale insulin >72 hours prior to randomization
- Patients who received basal insulin > 48 hours prior to randomization
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Emory University Hospital
Atlanta, Georgia, 30322
Grady Memorial Hospital
Atlanta, Georgia
Boston Medical Center
Boston, Massachusetts, 02118
Rush University Medical Center
Chicago, Illinois, 60612
University of Colorado
Denver, Colorado, 80220
About this study
Official title: Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes
This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.
The patients will be monitored for their blood sugars while the hospital.
If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
Read the detailed description
Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily glucose concentration and frequency of hypoglycemic events, is different between treatment with linagliptin (Tradjenta®) plus correction doses with a rapid-acting insulin analog before meals and a basal bolus regimen with glargine once daily and rapid-acting insulin analog before meals in general surgery patients with T2D.
Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital arm (Aim 1) will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 3 months.
- Conditions
- Type 2 Diabetes
- Being tested
- Linagliptin, Basal Bolus, Linagliptin + 50% Glargine dose on discharge, Linagliptin + 80% Glargine
- Keywords
- Diabetes, Linagliptin, hospital hyperglycemia, inpatient diabetes
- 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.
LinagliptinDrug
Also called Tradjenta
Linagliptin once daily + correction doses of rapid acting insulin if needed
Basal BolusDrug
Also called Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)
Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
LinagliptinDrug
Also called Trajenta
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
Linagliptin + 50% Glargine dose on dischargeDrug
Also called Trajenta, Lantus
Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.
Linagliptin + 80% GlargineDrug
Also called Trajenta, Lantus
Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Linagliptin In-hospital | Experimental | Linagliptin once daily+ correction doses of aspart or lispro if needed Receives: Drug: Linagliptin |
| Basal Bolus In-hospital | Active comparator | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Receives: Drug: Basal Bolus |
| Linagliptin on discharge | Experimental | Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily. Receives: Drug: Linagliptin |
| Linagliptin+50%Glargine dose on d/c | Experimental | Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day. Receives: Drug: Linagliptin + 50% Glargine dose on discharge |
| Linagliptin+80%Glargine dose on d/c | Experimental | Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day. Receives: Drug: Linagliptin + 80% Glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Glycemic Control
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Measured: Inpatient (average 5 days) and outpatient up to 12 weeks
Secondary outcomes (15)
Hypoglycemia <70 mg/dl
Subjects with Hypoglycemia <70 mg/dl
Measured: Inpatient (average 5 days) and outpatient up to 12 weeks
Hyperglycemia
Subjects with BG > 300 mg/dl
Measured: Inpatient (average 5 days) and outpatient up to 12 weeks
Daily Dose of Insulin
Total daily dose of insulin
Measured: Inpatient (average 5 days) and outpatient up to 12 weeks
Length of Hospital Stay
Length of hospital stay (ONLY for inpatient arms 1 and 2)
Measured: During Hospitalization
Number of Participants Requiring ICU Care During Hospitalization
Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization
Measured: During Hospitalization-average 5 days
Hospital Complications
Subjects with composite complication (ONLY for inpatient arms 1 and 2)
Measured: During Hospitalization-average 5 days
Acute Renal Failure During Hospitalization
Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)
Measured: During Hospitalization-average 5 days
Hospital Mortality
Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.
Measured: During Hospitalization-average 5 days
Fasting BG Concentration
Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)
Measured: During Hospitalization (average 5 days) and outpatient up to 12 weeks
Subjects With Wound and Other Infections
Subjects with wound and other infections.
Measured: During Hospitalization and outpatient up to 12 weeks
HbA1c Level
HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).
Measured: Admission to the hospital and 12-week follow-up outpatient visit
Hypoglycemia < 40 mg/dl
Subjects with Hypoglycemia < 40 mg/dl
Measured: Inpatient and up to 12 weeks outpatient
Emergency Room Visits
Number of ER visits ONLY for outpatient arms 3,4, and 5.
Measured: 3 months after discharge
Subjects With Surgical Reinterventions
Subjects with surgical re-interventions.
Measured: Inpatient and up to 12 weeks outpatient
Outpatient Mortality
Deaths among patients after hospital discharge.
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionFeb 2017
- Study completionMar 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.
- Other trials for Type 2 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
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, Rush University, University of Denver
- Responsible party
- Principal investigator, Guillermo Umpierrez, MD, Emory University
- Investigators
- Guillermo E Umpierrez, MD, Principal investigator, Emory University SOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004366
- Sponsor's protocol ID
- IRB00066548
- Status last verified
- Feb 2019
- First submitted
- 19 Nov 2013
- Last updated
- 20 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02004366
- Acronym / sponsor ID
- IRB00066548
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes, Linagliptin, hospital hyperglycemia, inpatient diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Boston Medical Center, Rush University, University of Denver
- Study start
- Jan 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 30 Oct 2018
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 prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.
The patients will be monitored for their blood sugars while the hospital.
If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
Detailed description
Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily glucose concentration and frequency of hypoglycemic events, is different between treatment with linagliptin (Tradjenta®) plus correction doses with a rapid-acting insulin analog before meals and a basal bolus regimen with glargine once daily and rapid-acting insulin analog before meals in general surgery patients with T2D.
Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital arm (Aim 1) will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Linagliptin In-hospital | Experimental | Drug: LinagliptinLinagliptin once daily+ correction doses of aspart or lispro if needed |
| Basal Bolus In-hospital | Active comparator | Drug: Basal BolusGlargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed |
| Linagliptin on discharge | Experimental | Drug: LinagliptinPatients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily. |
| Linagliptin+50%Glargine dose on d/c | Experimental | Drug: Linagliptin + 50% Glargine dose on dischargePatients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day. |
| Linagliptin+80%Glargine dose on d/c | Experimental | Drug: Linagliptin + 80% GlarginePatients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or female surgical non-ICU patients ages between18 and 80 years
- A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
- Subjects with a BG >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones)
Key exclusion criteria (14 listed)
- Age < 18 or > 80 years.
- Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
- Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
- Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
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: TradjentaLinagliptin once daily + correction doses of rapid acting insulin if needed | Drug | Linagliptin In-hospital |
| Basal BolusAlso: Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | Drug | Basal Bolus In-hospital |
| LinagliptinAlso: TrajentaPatients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | Drug | Linagliptin on discharge |
| Linagliptin + 50% Glargine dose on dischargeAlso: Trajenta, LantusPatients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months. | Drug | Linagliptin+50%Glargine dose on d/c |
| Linagliptin + 80% GlargineAlso: Trajenta, LantusPatients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months. | Drug | Linagliptin+80%Glargine dose on d/c |
Primary outcome
Differences in Glycemic Control
Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
15 secondary outcomes
Hypoglycemia <70 mg/dl
Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Hyperglycemia
Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Daily Dose of Insulin
Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Length of Hospital Stay
Time frame: During Hospitalization
Number of Participants Requiring ICU Care During Hospitalization
Time frame: During Hospitalization-average 5 days
Hospital Complications
Time frame: During Hospitalization-average 5 days
Acute Renal Failure During Hospitalization
Time frame: During Hospitalization-average 5 days
Hospital Mortality
Time frame: During Hospitalization-average 5 days
Fasting BG Concentration
Time frame: During Hospitalization (average 5 days) and outpatient up to 12 weeks
Subjects With Wound and Other Infections
Time frame: During Hospitalization and outpatient up to 12 weeks
HbA1c Level
Time frame: Admission to the hospital and 12-week follow-up outpatient visit
Hypoglycemia < 40 mg/dl
Time frame: Inpatient and up to 12 weeks outpatient
Emergency Room Visits
Time frame: 3 months after discharge
Subjects With Surgical Reinterventions
Time frame: Inpatient and up to 12 weeks outpatient
Outpatient Mortality
Time frame: 3 months after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- 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.
Guillermo E Umpierrez, MD principal investigator
Emory University SOM
5 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, Basal Bolus and Linagliptin + 50% Glargine dose on discharge in people with Type 2 Diabetes, run by Emory University at 5 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 3 inclusion and 14 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 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 30 Oct 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?
Differences in Glycemic Control (time frame: Inpatient (average 5 days) and outpatient up to 12 weeks). 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 20 Feb 2019.