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NCT Number: NCT02455076

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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).
  • 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).
  • Admission HbA1c between 7% and 10%
  • BMI range: > 25 Kg/m^2 and < 45 Kg/m^2

Exclusion criteria

  • Age < 18 or > 80 years
  • Subjects with increased blood glucose (BG) concentration, but without a history of diabetes (stress hyperglycemia)
  • 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).
  • Treatment with high-dose (>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3 months prior to admission.
  • Patients that required ICU care during the hospital admission.
  • Recurrent severe hypoglycemia or hypoglycemic unawareness.
  • Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or those expected to require gastrointestinal suction.
  • Patients with clinically relevant pancreatic or gallbladder disease.
  • Patients with unstable or rapidly progressing renal disease or severe renal impairment (creatinine clearance < 30 ml/min)
  • Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease),
  • History of hypersensitivity to exenatide
  • Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5 mg/day), parenteral nutrition and immunosuppressive treatment.
  • 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.
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Treatment and study plan

exenatide

Drug

Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.

Other names: Byetta

Glargine

Drug

Glargine will be given once daily, at the same time of day. If the BG is between 140-200 mg/dL, the dose will be 0.2 units/kg/day; for BG levels 201-400 mg/dL, the dose will be 0.25 units/kg/day. The patients will be discharged on glargine once daily at 50% of the hospital dose.The total daily dose (TDD) of glargine is based on the patient's fasting BG levels for the last 2 days.

  • FBG >180 mg/dL, no hypoglycemia; glargine increased by 4 IU.
  • FBG >140 mg/dL, no hypoglycemia; glargine increased by 2 IU.
  • FBG 100-140 mg/dL, no hypoglycemia; no change in dosage.
  • FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD.
  • FBG or RBG < 70 mg/dl, decrease glargine by 8 IU or 20% of TDD.
  • FBG or RBG < 40 mg/dl, decrease dose of glargine by 30%.

Other names: Lantus

Rapid-acting insulin analogs

Drug

If the BG levels are >140 mg/dL, rapid acting insulin analogs will be administered following the "supplemental/sliding scale" protocol. If a patient is able and expected to eat all or most of his/her meals, supplemental insulin will be administered before each meal and at bedtime following the "usual" dose of the sliding scale protocol. If a patient is not able to eat, supplemental insulin will be administered every 6 hours following the "sensitive" dose of the sliding scale. If the BG is 141-180 mg/dL, then 2,3 or 4 units of insulin will be given; for BG 181 - 220 mg/dL; the units of insulin will be 3, 4 or 6; for BG 221 - 260 mg/dL, the units of insulin will be 4,5 or 8; for BG 261 - 300 mg/dL, the units of insulin will be 5, 6 or 10; for BG 301 - 350, the insulin will be 6, 8 or 12 units; for BG 351 - 400 mg/dL, the units of insulin will be 7,10 or 14; for BG> 400 mg/dL, the insulin will be 8,12 or 16 units.

Primary outcomes

  1. Mean Daily Blood Glucose Concentration Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days.

    The levels of blood glucose (BG) will be measured before each meal and at bedtime using a glucose meter. Blood glucose will be measured at baseline and during the hospital stay (up to 10 days).

  2. Change in HbA1c Concentration Inpatient

    Time frame: 12 weeks from discharge.

    The difference in the levels of HbA1c at discharge and at 12 weeks from discharge will be measured. The A1C test result is reported as a percentage. The higher the percentage, the higher a person's blood glucose levels have been. A normal A1C level is below 5.7 percent.

Secondary outcomes

  1. Mean Fasting Blood Glucose Levels Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days.

    The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.

  2. Mean Premeal Blood Glucose Levels Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    The blood glucose levels prior to each meal will using a glucose meter.

  3. Incidence of Hypoglycemic Events Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    The number of patients with hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.

  4. Incidence of Hyperglycemic Events Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    Percent of readings with hyperglycemia (blood glucose levels > 240 mg/dL)

  5. Total Daily Dose of Insulin Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.

  6. Average Number of Days of Hospital Stay

    Time frame: Duration of hospital stay, an expected average of 10 days

    The average number of days in the hospital for subjects will be calculated.

  7. Incidence of the Need for ICU Care Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    The total number of patients who require transfer to the ICU will be recorded.

  8. Hospital Mortality

    Time frame: Duration of hospital stay, an expected average of 10 days

    The total number of subject deaths during hospital stay will be recorded.

  9. Hospital Complications

    Time frame: Duration of hospital stay, an expected average of 10 days

    The total number of subjects who experience hospital complications like nosocomial pneumonia, bacteremia, respiratory failure, acute renal failure, and wound infections (surgery patients) will be recorded. Nosocomial infections will be diagnosed based on standardized Centers for Disease Control (CDC) criteria.

  10. Incidence of Acute Kidney Injury Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    The number of patients who experience acute kidney injury diagnosed by an increment in serum creatinine >0.5 mg/dL from admission value or 50% of baseline value will be recorded.

  11. Incidence of Gastrointestinal Adverse Events Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.

  12. Number of Patients With Severe Hypoglycemic Events Inpatient

    Time frame: Duration of hospital stay, an expected average of 10 days

    Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be recorded.

  13. Incidence of Hospital Readmissions

    Time frame: 12 weeks after discharge

    The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.

  14. Mean Fasting Blood Glucose Levels During Outpatient Period

    Time frame: 12 weeks after discharge

    Fasting Blood Glucose Levels were measured using blood test

  15. Mean Daily Blood Glucose Concentration During Outpatient Period

    Time frame: 12 weeks after discharge

    Mean Daily Blood Glucose Concentration will be calculated and recorded.

  16. The Number of Patients With Hypoglycemia Outpatient

    Time frame: 12 weeks after discharge

    Occurrence of hypoglycemia (blood glucose levels < 70 mg) will be identified by blood test

  17. Number of Patients With Severe Hypoglycemic Events

    Time frame: 12 weeks after discharge

    Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be detected by blood test

  18. Change in Body Weight

    Time frame: Time of discharge, 12 weeks after discharge

    The change in Body Weight from discharge to 12 weeks after discharge will be recorded

  19. Change in Body Mass Index

    Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge

    The change in BMI from discharge to 12 weeks after discharge will be calculated

  20. Number of Patients Who Had Emergency Room Visits

    Time frame: 12 weeks after discharge

    The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.

  21. Number of Hospital Readmissions

    Time frame: 12 weeks after discharge

    Number of hospital readmissions during 12 weeks after discharge will be recorded

  22. Number of Acute Kidney Injury Events

    Time frame: 12 weeks from discharge.

    Number of Acute Kidney Injury events will be recorded

  23. Number of Severe Gastrointestinal Adverse Events

    Time frame: 12 weeks from discharge.

    Number of Severe (require hospitalization) Gastrointestinal Adverse Events

  24. Change in Systolic Blood Pressure

    Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge

    Change in Systolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded

  25. Change in Heart Rate

    Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge

    Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded

  26. Efficacy, Measured by HbA1c Levels and no Weight Gain

    Time frame: 12 weeks from discharge.

    Number of patients who have an HbA1c <7.0% and no weight gain at 12 weeks from discharge will be recorded.

  27. Efficacy, Measured by HbA1c Levels and no Hypoglycemia

    Time frame: 12 weeks from discharge.

    Number of patients who have an HbA1c <7.0% and no hypoglycemia at 12 weeks from discharge will be recorded.

  28. Change in Diastolic Blood Pressure

    Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge

    Change in Diastolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 27, 2015
Registry last updated
Jun 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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