NCT01378117

Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes

Randomized Controlled Study of Dipeptidyl Peptidase-4 (DPP4) Inhibitor (Sitagliptin) Therapy in the Inpatient Management of Patients With Type 2 Diabetes

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, prospective, open-label, randomized pilot study to investigate the safety and efficacy of sitagliptin (Januvia) for the inpatient management of type 2 diabetes (T2D) in general medicine and surgery patients.

Detailed description

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, but has not been tested in the hospital. It is not known if sitagliptin is as effective in controlling blood sugars in the hospital. This study will compare sitagliptin by mouth, insulin (glargine) injection, and the combination of sitagliptin and lantus insulin in controlling blood sugar in hospitalized patients with diabetes. In this pilot study, patients with known history of diabetes treated with diet and/or oral anti-diabetics or with low total daily dose insulin therapy (\<0.4 unit/kg/day) will be randomized to receive sitagliptin once daily (group 1), sitagliptin plus basal (glargine) insulin once daily (group 2), or basal bolus regimen with glargine once daily and lispro insulin before meals (group 3). If needed, patients in the 3 treatment groups will receive correction doses of rapid-acting lispro (Humalog®) insulin in the presence of hyperglycemia (BG \> 140 mg/dl) per sliding scale. The overall hypothesis is that treatment with sitagliptin once daily alone or in combination with basal insulin in patients with type 2 diabetes will result in a similar improvement in 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. A total of 90 subjects with type 2 diabetes will be recruited in this study. Patients will be recruited at Grady Memorial Hospital and Emory University Hospital.

Conditions

• Type 2 Diabetes Mellitus
• Hospitalization
• Hyperglycemia

Interventions

Type	Name	Description
DRUG	Sitagliptin	Sitagliptin 50-100mg po once daily
DRUG	glargine	glargine once daily
DRUG	lispro	lispro before meals

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2011-06-22
• Last updated: 2018-12-07
• Results posted: 2014-06-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study