Trial Outcomes & Findings for Linagliptin Inpatient Trial (NCT NCT02004366)
NCT ID: NCT02004366
Last Updated: 2019-02-20
Results Overview
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
295 participants
Primary outcome timeframe
Inpatient (average 5 days) and outpatient up to 12 weeks
Results posted on
2019-02-20
Participant Flow
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.
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.
Participant milestones
| Measure |
Linagliptin In-hospital
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
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
|
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|---|---|
|
In-hospital
STARTED
|
128
|
122
|
0
|
0
|
0
|
|
In-hospital
COMPLETED
|
128
|
122
|
0
|
0
|
0
|
|
In-hospital
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
On Discharge
STARTED
|
0
|
0
|
92
|
93
|
39
|
|
On Discharge
COMPLETED
|
0
|
0
|
92
|
93
|
39
|
|
On Discharge
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Linagliptin Inpatient Trial
Baseline characteristics by cohort
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily+ correction doses of aspart or lispro if needed
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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
n=474 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
In-hospital
|
58 years
STANDARD_DEVIATION 11 • n=5 Participants
|
58 years
STANDARD_DEVIATION 12 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=4 Participants
|
NA years
STANDARD_DEVIATION NA • n=21 Participants
|
57.8 years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
|
Age, Continuous
Discharge
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
50.7 years
STANDARD_DEVIATION 11.5 • n=21 Participants
|
56.7 years
STANDARD_DEVIATION 11.3 • n=10 Participants
|
|
Sex: Female, Male
In-hospital · Female
|
66 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
|
Sex: Female, Male
In-hospital · Male
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
NA Participants
n=5 Participants
|
NA Participants
n=4 Participants
|
NA Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
|
Sex: Female, Male
Discharge · Female
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
|
Sex: Female, Male
Discharge · Male
|
NA Participants
n=5 Participants
|
NA Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
NA Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
In-hospital Black
|
59 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
117 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
In-hospital White
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
90 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
In-hospital Hispanic
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
33 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
In-hospital Other
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Discharge Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
111 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Discharge White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
75 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Discharge Hispanic
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Discharge Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
United States · In-hospital
|
128 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
250 Participants
n=10 Participants
|
|
Region of Enrollment
United States · Discharged
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
224 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Inpatient (average 5 days) and outpatient up to 12 weeksDetermine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Differences in Glycemic Control
|
171 mg/dl
Standard Deviation 47
|
159 mg/dl
Standard Deviation 41
|
126 mg/dl
Standard Deviation 22
|
132 mg/dl
Standard Deviation 28
|
142 mg/dl
Standard Deviation 24
|
SECONDARY outcome
Timeframe: Inpatient (average 5 days) and outpatient up to 12 weeksSubjects with Hypoglycemia \<70 mg/dl
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Hypoglycemia <70 mg/dl
|
2 Participants
|
14 Participants
|
8 Participants
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Inpatient (average 5 days) and outpatient up to 12 weeksSubjects with BG \> 300 mg/dl
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Hyperglycemia
|
22 Participants
|
18 Participants
|
6 Participants
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Inpatient (average 5 days) and outpatient up to 12 weeksTotal daily dose of insulin
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Daily Dose of Insulin
|
0.09 units/kg/day
Standard Deviation 0.17
|
0.31 units/kg/day
Standard Deviation 0.15
|
0.23 units/kg/day
Standard Deviation 0.1
|
0.18 units/kg/day
Standard Deviation 0.1
|
0.24 units/kg/day
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: During HospitalizationPopulation: Length of hospital stay is applicable ONLY for inpatient arms (1 and 2)
Length of hospital stay (ONLY for inpatient arms 1 and 2)
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|---|---|
|
Length of Hospital Stay
|
4 Days
Interval 3.0 to 5.0
|
3 Days
Interval 3.0 to 6.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During Hospitalization-average 5 daysPopulation: Transfer to ICU is applicable ONLY for inpatient arms (1 and 2)
Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|---|---|
|
Number of Participants Requiring ICU Care During Hospitalization
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During Hospitalization-average 5 daysPopulation: Composite complication during hospitalization is applicable ONLY for inpatient arms (1 and 2)
Subjects with composite complication (ONLY for inpatient arms 1 and 2)
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|---|---|
|
Hospital Complications
|
14 Participants
|
11 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During Hospitalization-average 5 daysPopulation: Acute renal failure during hospitalization is applicable ONLY for inpatient arms (1 and 2)
Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|---|---|
|
Acute Renal Failure During Hospitalization
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During Hospitalization-average 5 daysPopulation: Hospital mortality is applicable ONLY for inpatients arms (1 and 2)
Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
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.
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.
|
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.
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.
|
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.
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.
|
|---|---|---|---|---|---|
|
Hospital Mortality
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During Hospitalization (average 5 days) and outpatient up to 12 weeksAverage - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Fasting BG Concentration
|
160 mg/dl
Standard Deviation 44
|
167 mg/dl
Standard Deviation 44
|
125 mg/dl
Standard Deviation 22
|
133 mg/dl
Standard Deviation 27
|
141 mg/dl
Standard Deviation 25
|
SECONDARY outcome
Timeframe: During Hospitalization and outpatient up to 12 weeksSubjects with wound and other infections.
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Subjects With Wound and Other Infections
|
7 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Admission to the hospital and 12-week follow-up outpatient visitHbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
HbA1c Level
|
7.6 % DCCT
Standard Deviation 1.9
|
8.0 % DCCT
Standard Deviation 2.0
|
6.6 % DCCT
Standard Deviation 0.8
|
7.0 % DCCT
Standard Deviation 1.0
|
8.6 % DCCT
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Inpatient and up to 12 weeks outpatientSubjects with Hypoglycemia \< 40 mg/dl
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Hypoglycemia < 40 mg/dl
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: Emergency visits reported only for outpatient time. Inpatient (hospital) patients cannot have ER visits
Number of ER visits ONLY for outpatient arms 3,4, and 5.
Outcome measures
| Measure |
Linagliptin In-hospital
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Emergency Room Visits
|
—
|
—
|
11 Visits
|
11 Visits
|
9 Visits
|
SECONDARY outcome
Timeframe: Inpatient and up to 12 weeks outpatientSubjects with surgical re-interventions.
Outcome measures
| Measure |
Linagliptin In-hospital
n=128 Participants
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 Participants
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Subjects With Surgical Reinterventions
|
6 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 months after dischargePopulation: Deaths after hospital discharge are applicable ONLY for outpatient arms (3, 4 and 5).
Deaths among patients after hospital discharge.
Outcome measures
| Measure |
Linagliptin In-hospital
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
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
|
Linagliptin on Discharge
n=92 Participants
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 Participants
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 Participants
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.
|
|---|---|---|---|---|---|
|
Outpatient Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Linagliptin In-hospital
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Basal Bolus In-hospital
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Linagliptin on Discharge
Serious events: 12 serious events
Other events: 3 other events
Deaths: 0 deaths
Linagliptin+50%Glargine Dose on d/c
Serious events: 14 serious events
Other events: 1 other events
Deaths: 0 deaths
Linagliptin+80%Glargine Dose on d/c
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Linagliptin In-hospital
n=128 participants at risk
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 participants at risk
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
|
Linagliptin on Discharge
n=92 participants at risk
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 participants at risk
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 participants at risk
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.
|
|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
ICU admission
|
0.78%
1/128 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.1%
1/92 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Surgical and medical procedures
Resurgery
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
5.4%
5/92 • Number of events 5 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
3.2%
3/93 • Number of events 7 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
7.7%
3/39 • Number of events 3 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Infections and infestations
Infection
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
3.3%
3/92 • Number of events 3 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
5.4%
5/93 • Number of events 6 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
10.3%
4/39 • Number of events 4 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
2.2%
2/92 • Number of events 2 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
2.2%
2/93 • Number of events 2 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Renal and urinary disorders
Genitourinary
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.1%
1/92 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Metabolism and nutrition disorders
Metabolic
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
5.1%
2/39 • Number of events 2 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
4.3%
4/93 • Number of events 4 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
Other adverse events
| Measure |
Linagliptin In-hospital
n=128 participants at risk
Linagliptin once daily + correction doses of aspart or lispro if needed.
Linagliptin: Linagliptin once daily + correction doses of rapid acting insulin if needed
|
Basal Bolus In-hospital
n=122 participants at risk
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
|
Linagliptin on Discharge
n=92 participants at risk
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.
|
Linagliptin+50%Glargine Dose on d/c
n=93 participants at risk
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.
|
Linagliptin+80%Glargine Dose on d/c
n=39 participants at risk
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.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
0.78%
1/128 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.6%
2/122 • Number of events 2 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.1%
1/92 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.1%
1/93 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Blood and lymphatic system disorders
Hematologic
|
2.3%
3/128 • Number of events 3 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.6%
2/122 • Number of events 2 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
1.6%
2/128 • Number of events 2 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Skin and subcutaneous tissue disorders
Skin
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.1%
1/92 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
0.00%
0/128 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/122 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
1.1%
1/92 • Number of events 1 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Surgical and medical procedures
Surgical Reintervention
|
4.7%
6/128 • Number of events 6 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
3.3%
4/122 • Number of events 4 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Renal and urinary disorders
Renal
|
4.7%
6/128 • Number of events 6 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
3.3%
4/122 • Number of events 4 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Infections and infestations
Infections
|
5.5%
7/128 • Number of events 7 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
2.5%
3/122 • Number of events 3 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/92 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/93 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/39 • 13 weeks (average 5 days in hospital and 12 weeks after discharge)
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place