Linagliptin Inpatient Trial
Study Details
Study Description
Brief 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. 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Linagliptin In-hospital Linagliptin once daily+ correction doses of aspart or lispro if needed |
Drug: Linagliptin
Linagliptin once daily + correction doses of rapid acting insulin if needed
Other Names:
|
Active Comparator: Basal Bolus In-hospital Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed |
Drug: Basal Bolus
Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
Other Names:
|
Experimental: Linagliptin on discharge 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. |
Drug: Linagliptin
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
Other Names:
|
Experimental: Linagliptin+50%Glargine dose on d/c 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. |
Drug: Linagliptin + 50% Glargine dose on discharge
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.
Other Names:
|
Experimental: Linagliptin+80%Glargine dose on d/c 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. |
Drug: Linagliptin + 80% Glargine
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Differences in Glycemic Control [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.
Secondary Outcome Measures
- Hypoglycemia <70 mg/dl [Inpatient (average 5 days) and outpatient up to 12 weeks]
Subjects with Hypoglycemia <70 mg/dl
- Hyperglycemia [Inpatient (average 5 days) and outpatient up to 12 weeks]
Subjects with BG > 300 mg/dl
- Daily Dose of Insulin [Inpatient (average 5 days) and outpatient up to 12 weeks]
Total daily dose of insulin
- Length of Hospital Stay [During Hospitalization]
Length of hospital stay (ONLY for inpatient arms 1 and 2)
- Number of Participants Requiring ICU Care During Hospitalization [During Hospitalization-average 5 days]
Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization
- Hospital Complications [During Hospitalization-average 5 days]
Subjects with composite complication (ONLY for inpatient arms 1 and 2)
- Acute Renal Failure During Hospitalization [During Hospitalization-average 5 days]
Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)
- Hospital Mortality [During Hospitalization-average 5 days]
Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.
- Fasting BG Concentration [During Hospitalization (average 5 days) and outpatient up to 12 weeks]
Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)
- Subjects With Wound and Other Infections [During Hospitalization and outpatient up to 12 weeks]
Subjects with wound and other infections.
- HbA1c Level [Admission to the hospital and 12-week follow-up outpatient visit]
HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).
- Hypoglycemia < 40 mg/dl [Inpatient and up to 12 weeks outpatient]
Subjects with Hypoglycemia < 40 mg/dl
- Emergency Room Visits [3 months after discharge]
Number of ER visits ONLY for outpatient arms 3,4, and 5.
- Subjects With Surgical Reinterventions [Inpatient and up to 12 weeks outpatient]
Subjects with surgical re-interventions.
- Outpatient Mortality [3 months after discharge]
Deaths among patients after hospital discharge.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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)
Exclusion Criteria:
-
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.
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Colorado | Denver | Colorado | United States | 80220 |
2 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
3 | Grady Memorial Hospital | Atlanta | Georgia | United States | |
4 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
5 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
Sponsors and Collaborators
- Emory University
- Boston Medical Center
- Rush University
- University of Denver
Investigators
- Principal Investigator: Guillermo E Umpierrez, MD, Emory University SOM
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB00066548
Study Results
Participant Flow
Recruitment Details | Participants were recruited between February 2014 and October 2016. Patients who participated in the in-hospital study period were invited to enroll in the prospective outpatient study. Of 250 in-patient participants, 224 accepted enrollment into outpatient study. |
---|---|
Pre-assignment Detail | Of the 295 subjects consented, there were 15 screen failures. 30 (out of remaining 280 patients) were excluded from participation: 11 patients stayed <24 hours, 1 patient received corticosteroids, and 18 patients didn't receive medication. Therefore, 250 patients started the study. |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Period Title: In-hospital | |||||
STARTED | 128 | 122 | 0 | 0 | 0 |
COMPLETED | 128 | 122 | 0 | 0 | 0 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Period Title: In-hospital | |||||
STARTED | 0 | 0 | 92 | 93 | 39 |
COMPLETED | 0 | 0 | 92 | 93 | 39 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c | Total |
---|---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily+ correction doses of aspart or lispro if needed Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. | Total of all reporting groups |
Overall Participants | 128 | 122 | 92 | 93 | 39 | 474 |
Age (years) [Mean (Standard Deviation) ] | ||||||
In-hospital |
58
(11)
|
58
(12)
|
NA
(NA)
|
NA
(NA)
|
NA
(NA)
|
57.8
(11.3)
|
Discharge |
NA
(NA)
|
NA
(NA)
|
58.8
(10.0)
|
57.1
(11.7)
|
50.7
(11.5)
|
56.7
(11.3)
|
Sex: Female, Male (Count of Participants) | ||||||
Female |
66
51.6%
|
58
47.5%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
Male |
62
48.4%
|
64
52.5%
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
NA
NaN
|
Female |
NA
NaN
|
NA
NaN
|
54
58.7%
|
49
52.7%
|
7
17.9%
|
NA
NaN
|
Male |
NA
NaN
|
NA
NaN
|
38
41.3%
|
44
47.3%
|
32
82.1%
|
NA
NaN
|
Race/Ethnicity, Customized (Count of Participants) | ||||||
In-hospital Black |
59
46.1%
|
58
47.5%
|
0
0%
|
0
0%
|
0
0%
|
117
24.7%
|
In-hospital White |
44
34.4%
|
46
37.7%
|
0
0%
|
0
0%
|
0
0%
|
90
19%
|
In-hospital Hispanic |
21
16.4%
|
12
9.8%
|
0
0%
|
0
0%
|
0
0%
|
33
7%
|
In-hospital Other |
4
3.1%
|
6
4.9%
|
0
0%
|
0
0%
|
0
0%
|
10
2.1%
|
Discharge Black |
0
0%
|
0
0%
|
42
45.7%
|
46
49.5%
|
23
59%
|
111
23.4%
|
Discharge White |
0
0%
|
0
0%
|
36
39.1%
|
33
35.5%
|
6
15.4%
|
75
15.8%
|
Discharge Hispanic |
0
0%
|
0
0%
|
13
14.1%
|
10
10.8%
|
5
12.8%
|
28
5.9%
|
Discharge Other |
0
0%
|
0
0%
|
1
1.1%
|
2
2.2%
|
4
10.3%
|
7
1.5%
|
Region of Enrollment (Count of Participants) | ||||||
In-hospital |
128
100%
|
122
100%
|
0
0%
|
0
0%
|
0
0%
|
250
52.7%
|
Discharged |
0
0%
|
0
0%
|
92
100%
|
93
100%
|
39
100%
|
224
47.3%
|
Outcome Measures
Title | Differences in Glycemic Control |
---|---|
Description | Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group. |
Time Frame | Inpatient (average 5 days) and outpatient up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Mean (Standard Deviation) [mg/dl] |
171
(47)
|
159
(41)
|
126
(22)
|
132
(28)
|
142
(24)
|
Title | Hypoglycemia <70 mg/dl |
---|---|
Description | Subjects with Hypoglycemia <70 mg/dl |
Time Frame | Inpatient (average 5 days) and outpatient up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Count of Participants [Participants] |
2
1.6%
|
14
11.5%
|
8
8.7%
|
15
16.1%
|
10
25.6%
|
Title | Hyperglycemia |
---|---|
Description | Subjects with BG > 300 mg/dl |
Time Frame | Inpatient (average 5 days) and outpatient up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Count of Participants [Participants] |
22
17.2%
|
18
14.8%
|
6
6.5%
|
11
11.8%
|
7
17.9%
|
Title | Daily Dose of Insulin |
---|---|
Description | Total daily dose of insulin |
Time Frame | Inpatient (average 5 days) and outpatient up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Mean (Standard Deviation) [units/kg/day] |
0.09
(0.17)
|
0.31
(0.15)
|
0.23
(0.1)
|
0.18
(0.1)
|
0.24
(0.1)
|
Title | Length of Hospital Stay |
---|---|
Description | Length of hospital stay (ONLY for inpatient arms 1 and 2) |
Time Frame | During Hospitalization |
Outcome Measure Data
Analysis Population Description |
---|
Length of hospital stay is applicable ONLY for inpatient arms (1 and 2) |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 0 | 0 | 0 |
Median (Inter-Quartile Range) [Days] |
4
|
3
|
Title | Number of Participants Requiring ICU Care During Hospitalization |
---|---|
Description | Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization |
Time Frame | During Hospitalization-average 5 days |
Outcome Measure Data
Analysis Population Description |
---|
Transfer to ICU is applicable ONLY for inpatient arms (1 and 2) |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily+ correction doses of aspart or lispro if needed Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 0 | 0 | 0 |
Count of Participants [Participants] |
1
0.8%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Hospital Complications |
---|---|
Description | Subjects with composite complication (ONLY for inpatient arms 1 and 2) |
Time Frame | During Hospitalization-average 5 days |
Outcome Measure Data
Analysis Population Description |
---|
Composite complication during hospitalization is applicable ONLY for inpatient arms (1 and 2) |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 0 | 0 | 0 |
Count of Participants [Participants] |
14
10.9%
|
11
9%
|
Title | Acute Renal Failure During Hospitalization |
---|---|
Description | Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2) |
Time Frame | During Hospitalization-average 5 days |
Outcome Measure Data
Analysis Population Description |
---|
Acute renal failure during hospitalization is applicable ONLY for inpatient arms (1 and 2) |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 0 | 0 | 0 |
Count of Participants [Participants] |
6
4.7%
|
4
3.3%
|
Title | Hospital Mortality |
---|---|
Description | Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay. |
Time Frame | During Hospitalization-average 5 days |
Outcome Measure Data
Analysis Population Description |
---|
Hospital mortality is applicable ONLY for inpatients arms (1 and 2) |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 0 | 0 | 0 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Fasting BG Concentration |
---|---|
Description | Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups) |
Time Frame | During Hospitalization (average 5 days) and outpatient up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Mean (Standard Deviation) [mg/dl] |
160
(44)
|
167
(44)
|
125
(22)
|
133
(27)
|
141
(25)
|
Title | Subjects With Wound and Other Infections |
---|---|
Description | Subjects with wound and other infections. |
Time Frame | During Hospitalization and outpatient up to 12 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Count of Participants [Participants] |
7
5.5%
|
3
2.5%
|
3
3.3%
|
5
5.4%
|
4
10.3%
|
Title | HbA1c Level |
---|---|
Description | HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms). |
Time Frame | Admission to the hospital and 12-week follow-up outpatient visit |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Mean (Standard Deviation) [% DCCT] |
7.6
(1.9)
|
8.0
(2.0)
|
6.6
(0.8)
|
7.0
(1.0)
|
8.6
(2.7)
|
Title | Hypoglycemia < 40 mg/dl |
---|---|
Description | Subjects with Hypoglycemia < 40 mg/dl |
Time Frame | Inpatient and up to 12 weeks outpatient |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Count of Participants [Participants] |
1
0.8%
|
0
0%
|
1
1.1%
|
0
0%
|
1
2.6%
|
Title | Emergency Room Visits |
---|---|
Description | Number of ER visits ONLY for outpatient arms 3,4, and 5. |
Time Frame | 3 months after discharge |
Outcome Measure Data
Analysis Population Description |
---|
Emergency visits reported only for outpatient time. Inpatient (hospital) patients cannot have ER visits |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 0 | 0 | 92 | 93 | 39 |
Number [Visits] |
11
|
11
|
9
|
Title | Subjects With Surgical Reinterventions |
---|---|
Description | Subjects with surgical re-interventions. |
Time Frame | Inpatient and up to 12 weeks outpatient |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 128 | 122 | 92 | 93 | 39 |
Count of Participants [Participants] |
6
4.7%
|
4
3.3%
|
5
5.4%
|
3
3.2%
|
3
7.7%
|
Title | Outpatient Mortality |
---|---|
Description | Deaths among patients after hospital discharge. |
Time Frame | 3 months after discharge |
Outcome Measure Data
Analysis Population Description |
---|
Deaths after hospital discharge are applicable ONLY for outpatient arms (3, 4 and 5). |
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c |
---|---|---|---|---|---|
Arm/Group Description | Linagliptin once daily+ correction doses of aspart or lispro if needed Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. |
Measure Participants | 0 | 0 | 92 | 93 | 39 |
Count of Participants [Participants] |
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Adverse Events
Time Frame | 13 weeks (average 5 days in hospital and 12 weeks after discharge) | |||||||||
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Adverse Event Reporting Description | Adverse Events were monitored/assessed without regard to the specific Adverse Event Term | |||||||||
Arm/Group Title | Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c | |||||
Arm/Group Description | Linagliptin once daily + correction doses of aspart or lispro if needed. Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed | Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed | 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. Linagliptin: Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months. | 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. Linagliptin + 50% Glargine dose on discharge: 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. | 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. Linagliptin + 80% Glargine: 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. | |||||
All Cause Mortality |
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Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/128 (0%) | 0/122 (0%) | 0/92 (0%) | 0/93 (0%) | 0/39 (0%) | |||||
Serious Adverse Events |
||||||||||
Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/128 (0.8%) | 0/122 (0%) | 12/92 (13%) | 14/93 (15.1%) | 9/39 (23.1%) | |||||
Gastrointestinal disorders | ||||||||||
Gastrointestinal | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 2/92 (2.2%) | 2 | 2/93 (2.2%) | 2 | 0/39 (0%) | 0 |
Infections and infestations | ||||||||||
Infection | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 3/92 (3.3%) | 3 | 5/93 (5.4%) | 6 | 4/39 (10.3%) | 4 |
Metabolism and nutrition disorders | ||||||||||
ICU admission | 1/128 (0.8%) | 1 | 0/122 (0%) | 0 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Metabolic | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 2/39 (5.1%) | 2 |
Musculoskeletal and connective tissue disorders | ||||||||||
Musculoskeletal | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 0/92 (0%) | 0 | 4/93 (4.3%) | 4 | 0/39 (0%) | 0 |
Renal and urinary disorders | ||||||||||
Genitourinary | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 1/92 (1.1%) | 1 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
Pulmonary | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 1/92 (1.1%) | 1 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Surgical and medical procedures | ||||||||||
Resurgery | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 5/92 (5.4%) | 5 | 3/93 (3.2%) | 7 | 3/39 (7.7%) | 3 |
Other (Not Including Serious) Adverse Events |
||||||||||
Linagliptin In-hospital | Basal Bolus In-hospital | Linagliptin on Discharge | Linagliptin+50%Glargine Dose on d/c | Linagliptin+80%Glargine Dose on d/c | ||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 25/128 (19.5%) | 15/122 (12.3%) | 3/92 (3.3%) | 1/93 (1.1%) | 0/39 (0%) | |||||
Blood and lymphatic system disorders | ||||||||||
Hematologic | 3/128 (2.3%) | 3 | 2/122 (1.6%) | 2 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Gastrointestinal disorders | ||||||||||
Gastrointestinal | 1/128 (0.8%) | 1 | 2/122 (1.6%) | 2 | 1/92 (1.1%) | 1 | 1/93 (1.1%) | 1 | 0/39 (0%) | 0 |
Infections and infestations | ||||||||||
Infections | 7/128 (5.5%) | 7 | 3/122 (2.5%) | 3 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||||||
Musculoskeletal | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 1/92 (1.1%) | 1 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Renal and urinary disorders | ||||||||||
Renal | 6/128 (4.7%) | 6 | 4/122 (3.3%) | 4 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||||
Pulmonary | 2/128 (1.6%) | 2 | 0/122 (0%) | 0 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||||
Skin | 0/128 (0%) | 0 | 0/122 (0%) | 0 | 1/92 (1.1%) | 1 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Surgical and medical procedures | ||||||||||
Surgical Reintervention | 6/128 (4.7%) | 6 | 4/122 (3.3%) | 4 | 0/92 (0%) | 0 | 0/93 (0%) | 0 | 0/39 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Priyathama Vellanki |
---|---|
Organization | Emory University |
Phone | 404-778-1665 |
priyathama.vellanki@emory.edu |
- IRB00066548