Phase 4
Completed N=90
Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes
Type 2 Diabetes Mellitus · Hospitalization · Hyperglycemia
Source: ClinicalTrials.gov NCT01378117 ↗
Enrolled (actual)
90
Serious AEs
1.2%
Results posted
Jun 2014
Primary outcomePrimary: Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy — 209; 203; 225; 168.4 mg/dl
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Blood Glucose Levels Among the Three Groups at the Time of Hospitalization to 1st Day After Therapy |
209; 203; 225; 168.4; 154.2; 158.3 | — |
| SECONDARY Number of Patients With Hypoglycemic Events Among the Treatment Groups |
1; 2; 2 | — |
| SECONDARY Number of Patients With Severe Hypoglycemic Episodes Among the 3 Treatment Groups |
0; 0; 0 | — |
| SECONDARY Number of Patients With a Mean Daily BG > 240 mg/dL After the 1st Day of Treatment Among the Treatment Groups |
3; 1; 2 | — |
| SECONDARY Mean Total Daily Dose of Insulin in Units/Day Given During Hospitalization Among the Three Groups |
11.5; 28.2; 39.8 | — |
| SECONDARY Mean Length of Stay in Days in the Hospital Among Different Groups |
6.3; 6.9; 6.3 | — |
| SECONDARY Number of Subjects With Acute Renal Failure Among the Three Randomized Groups During Hospitalization |
0; 0; 0 | — |
| SECONDARY Number of Deaths Among the Subjects in Different Groups |
0; 0; 0 | — |
| SECONDARY Percent of Blood Glucose Readings Within Target Range Between 70 and 140 mg/dL Among the Three Groups After 24 Hrs of Randomized Treatment |
36; 43; 43 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females between the ages of 18 and 80 years admitted to a general medicine and surgery services.
- A known history of type 2 diabetes mellitus > 3 months, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding Trazodone (TZDs) and DPP4 inhibitors), or low-dose (≤ 0.4 units/kg/day) insulin therapy.
- Subjects with a BG >140 mg and 80 years.
- Subjects with increased blood glucose concentration, but without a known 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 congestive heart failure (NYHA class III and IV), acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (serum creatinine ≥ 2.0 mg/dL).
- Treatment with oral or injectable corticosteroid.
- 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 (NCT01378117). 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. Informational only — not medical advice.