DPP4 Inhibitor in the Hospital

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01378117
• Date of registration: 07/03/2011
• Primary sponsor: Emory University
• Public title: DPP4 Inhibitor in the Hospital
• Scientific title: Randomized Controlled Study of DPP4 Inhibitor (Sitagliptin) Therapy in the Inpatient Management of Patients With Type 2 Diabetes
• Date of first enrolment: August 2011
• Target sample size: 90
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01378117
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Guillermo Umpierrez, MD
• Affiliation: Emory University SOM

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males or females between the ages of 18 and 80 years admitted to a general medicine
and surgery services.

2. A known history of T2DM > 3 months, receiving either diet alone, oral antidiabetic
agents: sulfonylureas and metformin as monotherapy or in combination therapy
(excluding TZDs and DPP4 inhibitors), or low-dose (= 0.4 units/kg/day) insulin
therapy.

3. Subjects with a BG >140 mg and < 400 mg/dL without laboratory evidence of diabetic
ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).

Exclusion Criteria:

1. Age < 18 or > 80 years.

2. Subjects with increased blood glucose concentration, but without a known history of
diabetes (stress hyperglycemia).

3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin
therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic
state, or ketonuria) [46].

4. History of TZD treatment (pioglitazone or rosiglitazone) or DPP4 inhibitor
(sitagliptin or saxagliptin) during the past 3 months prior to admission.

5. Acute critical illness or CABG surgery expected to require prolonged admission to a
critical care unit (ICU, CCU, SICU, neuro ICU).

6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to
require gastrointestinal suction.

7. Medical or surgical patients expected to be kept NPO for >24-48 hours after admission
or after completion of surgical procedure.

8. Patients with clinically relevant pancreatic or gallbladder disease.

9. 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).

10. Treatment with oral or injectable corticosteroid.

11. Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.

12. Female subjects are pregnant or breast feeding at time of enrollment into the study.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hospitalization

Hyperglycemia

Type 2 Diabetes Mellitus

Intervention(s)

Drug: glargine and lispro + SSI

Drug: Sitagliptin

Drug: sitagliptin and glargine

Primary Outcome(s)

glucose levels [Time Frame: during hospitalization, average 5 days]

Secondary Outcome(s)

Acute renal failure [Time Frame: during hospitalization, average 5 days]

Composite cardiac complications [Time Frame: during hospitalization, average 5 days]

Hospital mortality [Time Frame: during hospitalization, average 5 days]

Hyperglycemia [Time Frame: during hospitalization, average 5 days]

hypoglycemia [Time Frame: during hospitalization, average 5 days]

ICU need [Time Frame: during hospitalization, average 5 days]

severe hypoglycemia [Time Frame: during hospitalization, average 5 days]

Total daily dose of insulin [Time Frame: during hospitalization, average 5 days]

Secondary ID(s)

48954

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck