ADA Linagliptin in Long Term Care

NCT ID: NCT02061969

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-25
• Study Completion Date: 2017-04-10

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

insulin glargine

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

linagliptin

Intervention Type: DRUG

5mg linagliptin tablets

Interventions

linagliptin

5mg linagliptin tablets

Intervention Type: DRUG

insulin glargine

Intervention Type: DRUG

Other Intervention Names

Tradjenta; Lantus

Eligibility 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% 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Diabetes Association

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Crestvew Nursing Home

Atlanta, Georgia, United States

Budd Terrace Nursing Home

Atlanta, Georgia, United States

Wesley Woods Nursing Home

Atlanta, Georgia, United States

VA Nursing Home

Decatur, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29289540 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00071946

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00071545

Identifier Type: -

Identifier Source: org_study_id