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Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: Exenatide (Drug); Glargine (Drug); Oral antidiabetic drugs (Drug); Rapid-acting insulin analogs (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Guillermo E Umpierrez, MD, CDE, Principal Investigator, Affiliation: Emory University

Overall contact:
Guillermo E Umpierrez, MD, CDE, Phone: 404-778-1665, Email: geumpie@emory.edu

Summary

The purpose of this study is to try and achieve similar glycemic control in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in combination with basal insulin as compared to treatment with basal bolus insulin alone. The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established. Previous studies have shown that basal bolus insulin regimens improve glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin (SSRI) therapy, but has a significant risk of hypoglycemia. The investigators will compare the efficacy and safety of exenatide alone or in combination with basal insulin to control high blood glucose levels resulting in a lower risk of hypoglycemia.

Clinical Details

Official title: Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta) Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change in mean daily blood glucose concentration

Change in HbA1c concentration

Secondary outcome:

Mean fasting blood glucose levels

Mean premeal blood glucose levels

Incidence of hypoglycemic events

Incidence of hyperglycemic events

Total daily dose of insulin

Average number of days of hospital stay

Incidence of the need for ICU care

Hospital mortality

Hospital complications

Incidence of acute kidney injury

Incidence of gastrointestinal adverse events

Incidence of severe hypoglycemic events

Mean fasting blood glucose levels

Mean daily blood glucose concentration

Incidence of hypoglycemic events

Incidence of severe hypoglycemia

Change in body weight

Change in Body Mass Index (BMI)

Total daily dose of insulin

Incidence of emergency room visits

Incidence of hospital readmissions

Incidence of acute renal failure

Incidence of gastrointestinal adverse events

Change in blood pressure

Change in heart rate

Efficacy, measured by HbA1c levels and no weight gain

Efficacy, measured by HbA1c levels and no hypoglycemia

Detailed description: The association between hyperglycemia and poor clinical outcomes in patients with diabetes is well established. Data from previous trials in hospitalized patients have shown a strong association between hyperglycemia and poor clinical outcomes, such as mortality, morbidity, length of stay (LOS), infections and overall complications. Basal bolus insulin regimens improve glycemic control and reduce the rate of hospital complications compared to sliding scale regular insulin (SSRI). However, the use of basal bolus is labor intensive, requiring multiple daily insulin injections, and has a significant risk of hypoglycemia. The investigators will study if treatment with exenatide alone or in combination with basal insulin will result in similar glycemic control and a lower frequency of hypoglycemia than treatment with basal bolus in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. A known history of Type 2 Diabetes receiving either diet alone or oral antidiabetic drugs (OAD) including insulin secretagogues, pioglitazone, DPP4 inhibitors, or metformin as monotherapy or in combination therapy, or low-dose insulin at <0. 5 unit/kg/day. 2. Males or females between the ages of 18 and 80 years discharged after hospital admission from general medicine and surgery services (non-Intensive Care Unit setting). 3. Subjects with an admission / randomization BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones). 4. Admission HbA1c between 7% and 10% 5. BMI range: > 25 Kg/m^2 and < 45 Kg/m^2 Exclusion Criteria: 1. Age < 18 or > 80 years 2. Subjects with increased blood glucose (BG) concentration, but without a history of diabetes (stress hyperglycemia) 3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m^2 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria). 4. Treatment with high-dose (>0. 5 unit/kg/day) insulin or with GLP-1 RA during the past 3 months prior to admission. 5. Patients that required ICU care during the hospital admission. 6. Recurrent severe hypoglycemia or hypoglycemic unawareness. 7. Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction. 8. Patients with clinically relevant pancreatic or gallbladder disease. 9. Patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min) 10. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease), 11. History of hypersensitivity to exenatide 12. Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment. 13. Patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks per day) or drug abuse within 3 months prior to admission. 14. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 15. Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Locations and Contacts

Guillermo E Umpierrez, MD, CDE, Phone: 404-778-1665, Email: geumpie@emory.edu

Emory University Hospital, Atlanta, Georgia 30322, United States; Not yet recruiting
Guillermo E Umpierrez, MD, CDE, Phone: 404-779-1665, Email: geumpie@emory.edu
Saumeth Cardona, MD, Phone: 404-616-4827, Email: scardon@emory.edu

Grady Memorial Hospital, Atlanta, Georgia 30303, United States; Not yet recruiting
Guillermo E Umpierrez, MD, CDE, Phone: 404-778-1665, Email: geumpie@emory.edu
Saumeth Cardona, MD, Phone: 404-616-4827, Email: scardon@emory.edu

Additional Information

Starting date: May 2015
Last updated: May 26, 2015

Page last updated: August 23, 2015

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