Linagliptin Inpatient Trial

Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT02004366
Collaborator
Boston Medical Center (Other), Rush University (Other), University of Denver (Other)
295
5
5
37.9
59
1.6

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

Study Type:
Interventional
Actual Enrollment :
295 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Mar 1, 2017

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:
  • Tradjenta
  • 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:
  • Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)
  • 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:
  • Trajenta
  • 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:
  • Trajenta, Lantus
  • 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:
  • Trajenta, Lantus
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Hypoglycemia <70 mg/dl [Inpatient (average 5 days) and outpatient up to 12 weeks]

      Subjects with Hypoglycemia <70 mg/dl

    2. Hyperglycemia [Inpatient (average 5 days) and outpatient up to 12 weeks]

      Subjects with BG > 300 mg/dl

    3. Daily Dose of Insulin [Inpatient (average 5 days) and outpatient up to 12 weeks]

      Total daily dose of insulin

    4. Length of Hospital Stay [During Hospitalization]

      Length of hospital stay (ONLY for inpatient arms 1 and 2)

    5. 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

    6. Hospital Complications [During Hospitalization-average 5 days]

      Subjects with composite complication (ONLY for inpatient arms 1 and 2)

    7. Acute Renal Failure During Hospitalization [During Hospitalization-average 5 days]

      Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)

    8. Hospital Mortality [During Hospitalization-average 5 days]

      Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.

    9. 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)

    10. Subjects With Wound and Other Infections [During Hospitalization and outpatient up to 12 weeks]

      Subjects with wound and other infections.

    11. 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).

    12. Hypoglycemia < 40 mg/dl [Inpatient and up to 12 weeks outpatient]

      Subjects with Hypoglycemia < 40 mg/dl

    13. Emergency Room Visits [3 months after discharge]

      Number of ER visits ONLY for outpatient arms 3,4, and 5.

    14. Subjects With Surgical Reinterventions [Inpatient and up to 12 weeks outpatient]

      Subjects with surgical re-interventions.

    15. Outpatient Mortality [3 months after discharge]

      Deaths among patients after hospital discharge.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Males or female surgical non-ICU patients ages between18 and 80 years

    2. 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.

    3. 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:
    1. Age < 18 or > 80 years.

    2. Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).

    3. 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).

    4. Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.

    5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.

    6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.

    7. Patients with clinically relevant pancreatic or gallbladder disease.

    8. Patients with previous history of pancreatitis

    9. Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).

    10. Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day

    11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

    12. Pregnancy or breast feeding at time of enrollment into the study.

    13. Patients who received supplemental sliding scale insulin >72 hours prior to randomization

    14. 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.
    Responsible Party:
    Guillermo Umpierrez, MD, Professor of Medicine, Emory University
    ClinicalTrials.gov Identifier:
    NCT02004366
    Other Study ID Numbers:
    • IRB00066548
    First Posted:
    Dec 9, 2013
    Last Update Posted:
    Feb 20, 2019
    Last Verified:
    Feb 1, 2019
    Keywords provided by Guillermo Umpierrez, MD, Professor of Medicine, Emory University
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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)
    2. Secondary Outcome
    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%
    3. Secondary Outcome
    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%
    4. Secondary Outcome
    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)
    5. Secondary Outcome
    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
    6. Secondary Outcome
    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%
    7. Secondary Outcome
    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%
    8. Secondary Outcome
    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%
    9. Secondary Outcome
    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%
    10. Secondary Outcome
    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)
    11. Secondary Outcome
    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%
    12. Secondary Outcome
    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)
    13. Secondary Outcome
    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%
    14. Secondary Outcome
    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
    15. Secondary Outcome
    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%
    16. Secondary Outcome
    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]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame 13 weeks (average 5 days in hospital and 12 weeks after discharge)
    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
    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

    [Not Specified]

    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
    Email priyathama.vellanki@emory.edu
    Responsible Party:
    Guillermo Umpierrez, MD, Professor of Medicine, Emory University
    ClinicalTrials.gov Identifier:
    NCT02004366
    Other Study ID Numbers:
    • IRB00066548
    First Posted:
    Dec 9, 2013
    Last Update Posted:
    Feb 20, 2019
    Last Verified:
    Feb 1, 2019