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OpenTrials
Completed

NCT Number: NCT02061969

ADA Linagliptin in Long Term Care

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Budd Terrace Nursing Home, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Subjects with HbA1c > 7.5% and/or any blood glucose greater than or equal to 180 mg/dL

Exclusion criteria

  • Subjects with a history of type 1 diabetes or with a history of diabetic ketoacidosis
  • Treatment with insulin or GLP1 analogs during the past 3 months prior to admission.
  • Recurrent severe hypoglycemia or hypoglycemic unawareness.
  • Subjects with history of gastrointestinal obstruction or gastroparesis.
  • Patients with acute or chronic pancreatitis or pancreatic cancer.
  • 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).
  • Treatment with corticosteroids, parenteral nutrition and immunosuppressive treatment.
  • Mental condition rendering the subject unable to understand the nature and scope of the study.

Treatment and study plan

Linagliptin

Drug

5mg linagliptin tablets

Other names: Tradjenta

insulin glargine

Drug

Other names: Lantus

Primary outcomes

  1. 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.

Secondary outcomes

  1. HbA1c

    Time frame: 6 months

    HbA1c at 6 month

  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

    Data on changes in cognitive function were not collected

  6. 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).

  7. Total Number of Emergency Room Visits

    Time frame: 6 months

    Total number of emergency room visits during the study period

  8. Total Number of Hospital Visits

    Time frame: 6 months

    Total number of hospital visits during the study period

  9. 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.

  10. Incidence of Acute Kidney Injury

    Time frame: over 6 months

    Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy

  11. Mortality

    Time frame: over 6 months

    Mortality is defined as death occurring during admission at the LTC facility

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Long-Term Care Residents With Type 2 Diabetes

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2014
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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