Phase 4
N=250
Linagliptin Inpatient Trial
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02004366 ↗Enrolled (actual)
250
Serious AEs
7.6%
Results posted
Oct 2018
Primary outcome: Primary: Differences in Glycemic Control — 171; 159; 126; 132 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Linagliptin (Drug); Basal Bolus (Drug); Linagliptin + 50% Glargine dose on discharge (Drug); Linagliptin + 80% Glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences in Glycemic Control |
171; 159; 126; 132; 142 | — |
| SECONDARY Hypoglycemia <70 mg/dl |
2; 14; 8; 15; 10 | — |
| SECONDARY Hyperglycemia |
22; 18; 6; 11; 7 | — |
| SECONDARY Daily Dose of Insulin |
0.09; 0.31; 0.23; 0.18; 0.24 | — |
| SECONDARY Length of Hospital Stay |
4; 3 | — |
| SECONDARY Number of Participants Requiring ICU Care During Hospitalization |
1; 0; 0; 0; 0 | — |
| SECONDARY Hospital Complications |
14; 11 | — |
| SECONDARY Acute Renal Failure During Hospitalization |
6; 4 | — |
| SECONDARY Hospital Mortality |
0; 0 | — |
| SECONDARY Fasting BG Concentration |
160; 167; 125; 133; 141 | — |
| SECONDARY Subjects With Wound and Other Infections |
7; 3; 3; 5; 4 | — |
| SECONDARY HbA1c Level |
7.6; 8.0; 6.6; 7.0; 8.6 | — |
| SECONDARY Hypoglycemia < 40 mg/dl |
1; 0; 1; 0; 1 | — |
| SECONDARY Emergency Room Visits |
11; 11; 9 | — |
| SECONDARY Subjects With Surgical Reinterventions |
6; 4; 5; 3; 3 | — |
| SECONDARY Outpatient Mortality |
0; 0; 0; 0; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Males or female surgical non-ICU patients ages between18 and 80 years
- A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
- Subjects with a BG >140 mg and 80 years.
- Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
- Subjects with a history of type 1 diabetes (suggested by BMI 5 mg/day
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Pregnancy or breast feeding at time of enrollment into the study.
- Patients who received supplemental sliding scale insulin >72 hours prior to randomization
- Patients who received basal insulin > 48 hours prior to randomization
Data sourced from ClinicalTrials.gov (NCT02004366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.