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ADA Linagliptin in Long Term Care

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ClinicalTrials.gov Identifier: NCT02061969
Recruitment Status : Completed
First Posted : February 13, 2014
Results First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Tracking Information
First Submitted Date  ICMJE February 11, 2014
First Posted Date  ICMJE February 13, 2014
Results First Submitted Date  ICMJE May 8, 2018
Results First Posted Date  ICMJE August 22, 2018
Last Update Posted Date August 22, 2018
Study Start Date  ICMJE April 25, 2014
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
Mean Fasting Blood Glucose Level [ Time Frame: 6 months ]
The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Change in A1c at 6 months [ Time Frame: 6 months ]
The primary endpoint of the study is change in HbA1c over a 6-month treatment period between treatment with basal plus insulin regimen and aDDP4 inhibitor in LTC residents with poorly controlled diabetes.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2018)
  • HbA1c [ Time Frame: 6 months ]
    HbA1c at 6 month
  • Number of Hypoglycemic Events < 70mg/dl [ Time Frame: over 6 months ]
    total number of hypoglycemic events (<70 mg/dl)
  • Number of Hypoglycemic Events < 40mg/dl [ Time Frame: over 6 months ]
    total number of severe hypoglycemia (< 40 mg/dl).
  • Total Daily Dose of Insulin [ Time Frame: over 6 months ]
    Total daily dose of insulin (units)
  • Changes in Cognitive Function [ Time Frame: over 6 months ]
    Data on changes in cognitive function were not collected
  • Number of Participants With Acute Complications [ Time Frame: over 6 months ]
    Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).
  • Total Number of Emergency Room Visits [ Time Frame: 6 months ]
    Total number of emergency room visits during the study period
  • Total Number of Hospital Visits [ Time Frame: 6 months ]
    Total number of hospital visits during the study period
  • Total Number of Complications [ Time Frame: 6 months ]
    Total number of complications including urinary tract infections, pneumonia, diabetic foot infection, cardiac complications including myocardial infarction and heart failure, cerebrovascular accidents, and acute kidney injury and mortality.
  • Incidence of Acute Kidney Injury [ Time Frame: over 6 months ]
    Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy
  • Mortality [ Time Frame: over 6 months ]
    Mortality is defined as death occurring during admission at the LTC facility
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • change from baseline in fasting blood glucose between treatment groups [ Time Frame: at 6 months ]
    differences between treatment groups in change from baseline in fasting blood glucose between treatment groups.
  • change from baseline in mean blood glucose between treatment groups [ Time Frame: at 6 months ]
    differences between treatment groups in change from baseline in mean blood glucose between treatment groups.
  • Percentage with HbA1c ≤ 7.5% [ Time Frame: at 3 and 6 months ]
    Percentage of HbA1c ≤ 7.5% at 3 or 6 month independent of the occurrence of hypoglycemia.
  • Number of Hypoglycemic Events < 70mg/dl [ Time Frame: over 6 months ]
    total number of hypoglycemic events (<70 mg/dl)
  • Number of Hypoglycemic Events < 40mg/dl [ Time Frame: over 6 months ]
    total number of severe hypoglycemia (< 40 mg/dl).
  • Total Daily Dose of Insulin [ Time Frame: over 6 months ]
    Total daily dose of insulin (units)
  • Changes in Cognitive Function [ Time Frame: over 6 months ]
    5. Changes in cognitive function assessed by mini-mental examination
  • Prevalence of acute complications [ Time Frame: over 6 months ]
    Prevalence of acute complications (urinary tract infections, pneumonia), bedsores, diabetic foot infection.
  • number of emergency room visits [ Time Frame: 6 months ]
    emergency room visits during the study period
  • number of hospital visits [ Time Frame: 6 months ]
    hospital visits during the study period
  • Number of cardiac complications [ Time Frame: 6 months ]
    Cardiac complications are defined as myocardial infarction, cardiac arrhythmia and heart failure.
  • incidence of acute renal failure [ Time Frame: over 6 months ]
    Acute renal failure defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment > 0.5 mg/dL from baseline).
  • Mortality [ Time Frame: over 6 months ]
    Mortality is defined as death occurring during admission at the LTC facility
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ADA Linagliptin in Long Term Care
Official Title  ICMJE A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
Brief Summary This is a study to determine whether glycemic control, as measured by change in HbA1c and frequency of hypoglycemia, is different between treatment with linagliptin (Tradjenta®) and basal insulin in long term care residents(LTC) with Type 2 diabetes(T2D). Patients with poorly controlled diabetes (HbA1c >7.5%) will be randomized to a 6-month intervention with linagliptin or glargine insulin (± metformin for both treatments). Our hypothesis is that treatment with linagliptin, a once daily DPP4-inhibitor, will result in similar improvement in glucose control but in a lower rate of hypoglycemia than insulin treatment in LTC residents with T2D. We will also determine differences in clinical outcome, resource utilization, and hospitalization costs between LTC residents with T2D treated with linagliptin and basal and correction insulin. We will compare differences in complications (infectious and non-infectious, neurological and cardiovascular events), emergency room visits and hospitalizations between groups during the 6 months of intervention.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes
Intervention  ICMJE
  • Drug: linagliptin
    5mg linagliptin tablets
    Other Name: Tradjenta
  • Drug: insulin glargine
    Other Name: Lantus
Study Arms  ICMJE
  • Active Comparator: Insulin glargine
    Insulin glargine starting at 0.1 unit/kg/day added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.
    Intervention: Drug: insulin glargine
  • Experimental: linagliptin
    Oral linagliptin 5mg once daily added to ongoing metformin if the patient is already on it. The duration will be for a 6-month period.
    Intervention: Drug: linagliptin
Publications * Umpierrez GE, Cardona S, Chachkhiani D, Fayfman M, Saiyed S, Wang H, Vellanki P, Haw JS, Olson DE, Pasquel FJ, Johnson TM 2nd. A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial. J Am Med Dir Assoc. 2018 May;19(5):399-404.e3. doi: 10.1016/j.jamda.2017.11.002. Epub 2017 Dec 27. Erratum in: J Am Med Dir Assoc. 2019 Jul;20(7):925.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2018)
140
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
150
Actual Study Completion Date  ICMJE April 10, 2017
Actual Primary Completion Date April 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males or females with known history of type 2 diabetes, treated with diet, OADs as monotherapy or in combination therapy (excluding DPP4 inhibitors), or sliding scale insulin.
  2. Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

Exclusion Criteria:

  1. Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
  2. Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
  3. Recurrent severe hypoglycemia or hypoglycemic unawareness.
  4. Subjects with history of gastrointestinal obstruction or gastroparesis.
  5. Patients with acute or chronic pancreatitis or pancreatic cancer.
  6. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 45 ml/min).
  7. Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
  8. Mental condition rendering the subject unable to understand the nature and scope of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061969
Other Study ID Numbers  ICMJE IRB00071545
IRB00071946 ( Other Identifier: VA site IRB number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guillermo Umpierrez, MD, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Guillermo Umpierrez, MD Emory University
PRS Account Emory University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP