ADA Linagliptin in Long Term Care

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Emory University
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT02061969
First received: February 11, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes
Drug: linagliptin
Drug: insulin glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in A1c at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • change from baseline in fasting blood glucose between treatment groups [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    total number of hypoglycemic events (<70 mg/dl)

  • Number of hypoglycemic events < 40mg/dl [ Time Frame: over 6 months ] [ Designated as safety issue: Yes ]
    total number of severe hypoglycemia (< 40 mg/dl).

  • Total daily dose of insulin [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
    Total daily dose of insulin (units)

  • Changes in cognitive function [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
    5. Changes in cognitive function assessed by mini-mental examination

  • Prevalence of acute complications [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
    Prevalence of acute complications (urinary tract infections, pneumonia), bedsores, diabetic foot infection.

  • number of emergency room visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    emergency room visits during the study period

  • number of hospital visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    hospital visits during the study period

  • Number of cardiac complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cardiac complications are defined as myocardial infarction, cardiac arrhythmia and heart failure.

  • incidence of acute renal failure [ Time Frame: over 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Mortality is defined as death occurring during admission at the LTC facility


Estimated Enrollment: 150
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061969

Contacts
Contact: Guillermo E Umpierrez, MD 4047781665 geumpie@emory.edu
Contact: Dawn Smiley, MD, MSCR dsmiley@emory.edu

Locations
United States, Georgia
Budd Terrace Nursing Home Not yet recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Guillermo Umpierrez, MD         
Crestvew Nursing Home Not yet recruiting
Atlanta, Georgia, United States, 30315
Sub-Investigator: Dawn Smiley, MD, MSCR         
Wesley Woods Nursing Home Not yet recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Guillermo Umpierrez         
VA Nursing Home Not yet recruiting
Decatur, Georgia, United States, 30033
Sub-Investigator: Darin Olson, MD, PhD         
Sponsors and Collaborators
Emory University
American Diabetes Association
Investigators
Principal Investigator: Guillermo Umpierrez, MD Emory University
  More Information

No publications provided

Responsible Party: Guillermo Umpierrez, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT02061969     History of Changes
Other Study ID Numbers: IRB0071545
Study First Received: February 11, 2014
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Linagliptin
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014