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ADA Linagliptin in Long Term Care
Phase 4 trial testing linagliptin in Diabetes in 140 participants. Completed in 10 April 2017.
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 25 April 2014 |
| Primary completion | 10 April 2017 |
| Estimated completion | 10 April 2017 |
| Sites | 4 locations across United States |
Emory University
18 and older, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary endpoint of the study is differences between treatment groups in mean fasting blood glucose level in LTC residents with poorly controlled diabetes.
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 136.4 | ± 35 |
| Linagliptin | 131.2 | ± 27 |
HbA1c at 6 month
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 6.58 | ± 0.7 |
| Linagliptin | 6.82 | ± 0.6 |
total number of hypoglycemic events (\<70 mg/dl)
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 136 | |
| Linagliptin | 3 |
total number of severe hypoglycemia (\< 40 mg/dl).
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 3 | |
| Linagliptin | 0 |
Total daily dose of insulin (units)
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 12.0 | ± 9.9 |
| Linagliptin | 4.03 | ± 1.7 |
Number of Participants with Acute Complications (urinary tract infections, pneumonia, bedsores, diabetic foot infection).
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 8 | |
| Linagliptin | 5 |
Total number of emergency room visits during the study period
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 3 | |
| Linagliptin | 0 |
Total number of hospital visits during the study period
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 6 | |
| Linagliptin | 7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 22 | |
| Linagliptin | 16 |
Acute kidney injury in LTC Residents Treated with Basal Insulin and Linagliptin Therapy
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 2 | |
| Linagliptin | 1 |
Mortality is defined as death occurring during admission at the LTC facility
| Group | Value | 95% CI |
|---|---|---|
| Insulin Glargine | 0 | |
| Linagliptin | 2 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Insulin Glargine | Linagliptin |
|---|---|---|---|
| Hospitalized for Altered Mental Status | Psychiatric disorders | — | — |
| Hospitalized for repair craninectomy | Surgical and medical procedures | — | — |
| Hospitalized for aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Hospitalization for pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Hospitalization for congestive heart failure ( exacerbation | Cardiac disorders | — | — |
| Right stump infection | Infections and infestations | — | — |
| Hospitalized for brain edema | Nervous system disorders | — | — |
| Hospitalized for severe aortic stenosis | Cardiac disorders | — | — |
| Amputation of the left 2nd toe | Surgical and medical procedures | — | — |
| Wound infection | Infections and infestations | — | — |
| Reaction | System | Insulin Glargine | Linagliptin |
|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | — | — |
| Acute renal failure | Renal and urinary disorders | — | — |
| Shingels | Skin and subcutaneous tissue disorders | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Chest pain | Cardiac disorders | — | — |
| Hematuria | Renal and urinary disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — |
| Bradicardia | Cardiac disorders | — | — |
| Hypotension | Cardiac disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Penile infection | Reproductive system and breast disorders | — | — |
| Fall | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Hospitalized for Altered Mental Status, Hospitalized for repair craninectomy, Hospitalized for aspiration pneumonia, Hospitalization for pleural effusion, Hospitalization for congestive heart failure ( exacerbation, Right stump infection, Hospitalized for brain edema, Hospitalized for severe aortic stenosis.
Data from ClinicalTrials.gov NCT02061969 adverse events section.
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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