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Randomized Controlled Trial on the Safety and Efficacy of Sitagliptin Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes
High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Glargine (Lantus®) insulin injection is the most common treatment of diabetes in the hospital. Sitagliptin (Januvia®)is effective in lowering blood glucose. In a recent pilot study aiming to determine differences in glycemic control between treatment with sitagliptin (Januvia®) alone or in combination with basal insulin and basal bolus regimen in general medicine and surgery patients with type 2 diabetes (T2D). The investigators found that treatment with sitagliptin alone or in combination with basal insulin resulted in similar glycemic control compared to basal bolus regimen. The investigators will conduct a prospective RCT aimed to determine the safety and efficacy of sitagliptin therapy for in-hospital and post-discharge management of general medicine and surgical patients with T2D. A total of 280 patients with known history of diabetes will be randomized to receive sitagliptin plus basal (glargine) insulin once daily (group 1), or basal bolus regimen with glargine once daily and aspart or lispro insulin before meals (group 2). If needed, patients in the treatment groups will receive correction doses of rapid-acting insulin in the presence of hyperglycemia (BG \> 140 mg/dl). The overall hypothesis is that treatment with sitagliptin in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in hospital and post-discharge glycemic control and in a lower frequency of hypoglycemic events than treatment with basal bolus insulin regimen with glargine once daily and lispro insulin before meals. Patients will be recruited at Grady Memorial Hospital, Emory University Hospital, University of Michigan, Ohio State University and Temple University
Details
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 292 |
| Start date | 2013-08 |
| Completion | 2016-04 |
Conditions
- Type 2 Diabetes
Interventions
- Sitagliptin
- Basal Bolus
- Metformin and Sitagliptin
- Glargine
- Glargine 50%
- Glargine 80%
Primary outcomes
- Mean Blood Glucose Concentration After First Day of Treatment — Duration of Hospitalization (Up to 10 Days)
The average blood glucose (BG) concentration after the first day of treatment - Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L — Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D. - Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L — Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D. - Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L — Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D. - Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L — Duration of Hospitalization (Up to 10 Days)
Differences in glycemic control as measured by mean daily blood glucose (BG) concentration between sitagliptin once daily and basal bolus therapy with glargine once daily plus supplemental lispro insulin in hospitalized patients with T2D. - Change in HbA1C — Post Hospital Discharge Month 3, Month 6
The mean HbA1C measured at 3 months and 6 months post hospitalization. HbA1C is an indicator of diabetes control; below 6.0% is normal, 6.0% to 6.4% indicates prediabetes, and 6.5% or over indicates diabetes.
Countries
United States