Phase 4
N=279
Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01845831 ↗Enrolled (actual)
279
Serious AEs
6.9%
Results posted
May 2017
Primary outcome: Primary: Mean Blood Glucose Concentration After First Day of Treatment — 9.5; 9.4 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin (Drug); Basal Bolus (Drug); Metformin and Sitagliptin (Drug); Glargine (Drug); Glargine 50% (Drug); Glargine 80% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Blood Glucose Concentration After First Day of Treatment |
9.5; 9.4 | — |
| PRIMARY Mean Percentage of Blood Glucose Readings Between 3.9 - 7.8 mmol/L |
30.7; 29.7 | — |
| PRIMARY Mean Percentage of Blood Glucose Readings Between 3.9 - 10.0 mmol/L |
57.0; 59.6 | — |
| PRIMARY Mean Percentage of Blood Glucose Readings Between 5.6 - 7.8 mmol/L |
23.3; 23.5 | — |
| PRIMARY Mean Percentage of Blood Glucose Readings Greater Than 13.3 mmol/L |
14.8; 16.7 | — |
| PRIMARY Change in HbA1C |
6.3; 8.0; 11.3; 6.3; 7.3; 8.0 | — |
| SECONDARY Number of Participants With a Hypoglycemic Event |
13; 17; 0; 0 | — |
| SECONDARY Total Daily Insulin Dose |
24.1; 34.0 | — |
| SECONDARY Length of Hospital Stay |
4.0; 4.0 | — |
| SECONDARY Acute Renal Failure Rate |
7; 6 | — |
| SECONDARY Hospital Mortality Rate |
0; 0 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 80 years admitted to medicine and surgery services.
- A known history of Type 2 Diabetes > 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 (≤ 0.6 units/kg/day) insulin therapy.
- Subjects with a blood glucose >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 24-48 hours after admission or after completion of surgical procedure.
- Patients with clinically relevant pancreatic or gallbladder disease.
- Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR prednisone 5 mg/per day.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Female subjects are pregnant or breast feeding at time of enrollment into the study.
Data sourced from ClinicalTrials.gov (NCT01845831). 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.