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Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes
This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are \> 140 mg/dl. The patients will be monitored for their blood sugars while the hospital. If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.
Details
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 295 |
| Start date | 2014-01 |
| Completion | 2017-03 |
Conditions
- Type 2 Diabetes
Interventions
- Linagliptin
- Basal Bolus
- Linagliptin
- Linagliptin + 50% Glargine dose on discharge
- Linagliptin + 80% Glargine
Primary outcomes
- Differences in Glycemic Control — Inpatient (average 5 days) and outpatient up to 12 weeks
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Countries
United States