Sitagliptin for Hyperglycemia in Patients With T2DM Undergoing Cardiac Surgery (SITA-CABGDM)

Emory University

Status and phase: Completed; Phase 4

Conditions: Hyperglycemia

Treatments: Drug: Supplemental insulin (Insulin aspart); Drug: Sitagliptin; Drug: Placebo; Drug: Insulin glargine; Drug: Supplemental insulin (Insulin lispro); Drug: Regular Human Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02556918

IRB00082180

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) after cardiac surgery and to determine whether treatment with sitagliptin is effective in maintaining blood sugar control in patients with type 2 diabetes (T2D).

Full description

The purpose of this study is to determine whether treatment with sitagliptin reduces the frequency and severity of high blood sugar (hyperglycemia) and the need for continuous intravenous insulin infusion (CII) in the intensive care unit (ICU) in patients with type 2 diabetes (T2D) undergoing coronary artery bypass graft (CABG) surgery. In addition, the study seeks to determine whether treatment with sitagliptin is effective in maintaining glycemic control and in preventing the need for subcutaneous (SC) insulin therapy in patients with T2D during the transition from intensive care unit (ICU) to regular floor in cardiac surgery patients with T2D.

Enrollment: 202 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The ability to provide informed consent
• Ages 18 to 80 years old
• Male or female
• Scheduled to undergo cardiac surgery
• Type 2 Diabetes treated with diet, oral agents,

Exclusion criteria

• Severely impaired kidney function (glomeruler filtration rate (GFR ) less than 30 ml/min)
• Clinically significant liver failure
• Imminent risk of death (brain death or cardiac standstill)
• Gastrointestinal obstruction or adynamic ileus
• Expected to require gastrointestinal suction
• Clinically relevant pancreatic or gallbladder disease
• Using 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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202 participants in 2 patient groups, including a placebo group

Sitagliptin

Experimental group

Description:

Subjects undergoing cardiac surgery with type 2 diabetes (T2D) will be randomized to receive one tablet of sitagliptin once a day.Subjects with stress hyperglycemia (defined as a blood glucose (BG) greater than 180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level. Interventions: Drug: Sitagliptin Drug: Regular Human Insulin Drug: Insulin glargine Drug: Supplemental insulin (Insulin lispro) Drug: Supplemental insulin (Insulin aspart)

Treatment:

Drug: Regular Human Insulin

Drug: Insulin glargine

Drug: Sitagliptin

Drug: Supplemental insulin (Insulin lispro)

Drug: Supplemental insulin (Insulin aspart)

Placebo

Placebo Comparator group

Description:

Subjects undergoing cardiac surgery with type 2 diabetes will be randomized to receive one tablet of placebo once a day.Subjects with stress hyperglycemia (defined as a blood glucose (BG) greater than 180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level. Interventions: Drug: Placebo Drug: Regular Human Insulin Drug: Insulin glargine Drug: Supplemental insulin (Insulin lispro) Drug: Supplemental insulin (Insulin aspart)

Treatment:

Drug: Regular Human Insulin

Drug: Insulin glargine

Drug: Supplemental insulin (Insulin lispro)

Drug: Placebo

Drug: Supplemental insulin (Insulin aspart)