ADA Linagliptin in Long Term Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061969
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : August 16, 2017
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: linagliptin Drug: insulin glargine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes
Study Start Date : April 25, 2014
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : April 10, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: insulin glargine
Other Name: Lantus
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.
Drug: linagliptin
5mg linagliptin tablets
Other Name: Tradjenta

Primary Outcome Measures :
  1. change from baseline in mean blood glucose between treatment groups [ Time Frame: 6 months ]
    The primary endpoint of the study is differences between treatment groups in change from baseline in fasting blood aDDP4 inhibitor in LTC residents with poorly controlled diabetes.

Secondary Outcome Measures :
  1. 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.

  2. Number of hypoglycemic events < 70mg/dl [ Time Frame: over 6 months ]
    total number of hypoglycemic events (<70 mg/dl)

  3. Number of hypoglycemic events < 40mg/dl [ Time Frame: over 6 months ]
    total number of severe hypoglycemia (< 40 mg/dl).

  4. Total daily dose of insulin [ Time Frame: over 6 months ]
    Total daily dose of insulin (units)

  5. Changes in cognitive function [ Time Frame: over 6 months ]
    Changes in cognitive function assessed by mini-mental examination

  6. Prevalence of acute complications [ Time Frame: over 6 months ]
    Prevalence of acute complications (urinary tract infections, pneumonia), bedsores, diabetic foot infection.

  7. number of emergency room visits [ Time Frame: 6 months ]
    emergency room visits during the study period

  8. number of hospital visits [ Time Frame: 6 months ]
    hospital visits during the study period

  9. Number of cardiac complications [ Time Frame: 6 months ]
    Cardiac complications are defined as myocardial infarction, cardiac arrhythmia and heart failure.

  10. 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).

  11. Mortality [ Time Frame: over 6 months ]
    Mortality is defined as death occurring during admission at the LTC facility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02061969

United States, Georgia
Crestvew Nursing Home
Atlanta, Georgia, United States, 30315
Budd Terrace Nursing Home
Atlanta, Georgia, United States, 30322
Wesley Woods Nursing Home
Atlanta, Georgia, United States, 30322
VA Nursing Home
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
American Diabetes Association
Principal Investigator: Guillermo Umpierrez, MD Emory University

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University Identifier: NCT02061969     History of Changes
Other Study ID Numbers: IRB00071545
IRB00071946 ( Other Identifier: VA site IRB number )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017

Keywords provided by Guillermo Umpierrez, Emory University:
nursing home facility
long-term care facility
older patients
elderly patients
type 2 diabetes

Additional relevant MeSH terms:
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action