Type 2 DiabetesPhase 4NCT02455076
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
A Phase 4 study testing Exenatide, Glargine and Rapid-acting insulin analogs in people with Type 2 Diabetes, run by Emory University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exenatide, Glargine and Rapid-acting insulin analogs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital
Atlanta, Georgia, 30322
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Exenatide, Glargine, Rapid-acting insulin analogs
- Keywords
- Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
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.
GlargineDrug
Also called Lantus
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%.
Rapid-acting insulin analogsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Exenatide inpatient | Active comparator | Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide (Byetta®) twice daily. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. Receives: Drug: Exenatide |
| Exenatide plus glargine insulin inpatient | Active comparator | Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide twice daily and glargine once daily. Glargine insulin will be given once daily at the same time. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. Receives: Drug: Exenatide; Drug: Glargine |
| Basal bolus regimen inpatient | Active comparator | Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. Receives: Drug: Glargine; Drug: Rapid-acting insulin analogs |
| Exenatide outpatient | Active comparator | Patients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide (Byetta®) twice daily. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. Receives: Drug: Exenatide |
| Insulin Only | Active comparator | Patients with Type 2 Diabetes will be treated with Insulin only Receives: Drug: Glargine; Drug: Rapid-acting insulin analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Daily Blood Glucose Concentration Inpatient
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).
Measured: Duration of hospital stay, an expected average of 10 days.
Change in HbA1c Concentration Inpatient
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.
Measured: 12 weeks from discharge.
Secondary outcomes (28)
Mean Fasting Blood Glucose Levels Inpatient
The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.
Measured: Duration of hospital stay, an expected average of 10 days.
Mean Premeal Blood Glucose Levels Inpatient
The blood glucose levels prior to each meal will using a glucose meter.
Measured: Duration of hospital stay, an expected average of 10 days
Incidence of Hypoglycemic Events Inpatient
The number of patients with hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.
Measured: Duration of hospital stay, an expected average of 10 days
Incidence of Hyperglycemic Events Inpatient
Percent of readings with hyperglycemia (blood glucose levels > 240 mg/dL)
Measured: Duration of hospital stay, an expected average of 10 days
Total Daily Dose of Insulin Inpatient
The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.
Measured: Duration of hospital stay, an expected average of 10 days
Average Number of Days of Hospital Stay
The average number of days in the hospital for subjects will be calculated.
Measured: Duration of hospital stay, an expected average of 10 days
Incidence of the Need for ICU Care Inpatient
The total number of patients who require transfer to the ICU will be recorded.
Measured: Duration of hospital stay, an expected average of 10 days
Hospital Mortality
The total number of subject deaths during hospital stay will be recorded.
Measured: Duration of hospital stay, an expected average of 10 days
Hospital Complications
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.
Measured: Duration of hospital stay, an expected average of 10 days
Incidence of Acute Kidney Injury Inpatient
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.
Measured: Duration of hospital stay, an expected average of 10 days
Incidence of Gastrointestinal Adverse Events Inpatient
The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.
Measured: Duration of hospital stay, an expected average of 10 days
Number of Patients With Severe Hypoglycemic Events Inpatient
Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be recorded.
Measured: Duration of hospital stay, an expected average of 10 days
Incidence of Hospital Readmissions
The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.
Measured: 12 weeks after discharge
Mean Fasting Blood Glucose Levels During Outpatient Period
Fasting Blood Glucose Levels were measured using blood test
Measured: 12 weeks after discharge
Mean Daily Blood Glucose Concentration During Outpatient Period
Mean Daily Blood Glucose Concentration will be calculated and recorded.
Measured: 12 weeks after discharge
The Number of Patients With Hypoglycemia Outpatient
Occurrence of hypoglycemia (blood glucose levels < 70 mg) will be identified by blood test
Measured: 12 weeks after discharge
Number of Patients With Severe Hypoglycemic Events
Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be detected by blood test
Measured: 12 weeks after discharge
Change in Body Weight
The change in Body Weight from discharge to 12 weeks after discharge will be recorded
Measured: Time of discharge, 12 weeks after discharge
Change in Body Mass Index
The change in BMI from discharge to 12 weeks after discharge will be calculated
Measured: Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge
Number of Patients Who Had Emergency Room Visits
The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.
Measured: 12 weeks after discharge
Number of Hospital Readmissions
Number of hospital readmissions during 12 weeks after discharge will be recorded
Measured: 12 weeks after discharge
Number of Acute Kidney Injury Events
Number of Acute Kidney Injury events will be recorded
Measured: 12 weeks from discharge.
Number of Severe Gastrointestinal Adverse Events
Number of Severe (require hospitalization) Gastrointestinal Adverse Events
Measured: 12 weeks from discharge.
Change in Systolic Blood Pressure
Change in Systolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded
Measured: Discharge (after day 10 or hospital stay), 12 weeks after discharge
Change in Heart Rate
Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded
Measured: Discharge (after day 10 or hospital stay), 12 weeks after discharge
Efficacy, Measured by HbA1c Levels and no Weight Gain
Number of patients who have an HbA1c <7.0% and no weight gain at 12 weeks from discharge will be recorded.
Measured: 12 weeks from discharge.
Efficacy, Measured by HbA1c Levels and no Hypoglycemia
Number of patients who have an HbA1c <7.0% and no hypoglycemia at 12 weeks from discharge will be recorded.
Measured: 12 weeks from discharge.
Change in Diastolic Blood Pressure
Change in Diastolic Blood Pressure from the time of discharge to 12 weeks after discharge will be recorded
Measured: Discharge (after day 10 or hospital stay), 12 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, MD, Emory University
- Investigators
- Guillermo E Umpierrez, MD, CDE, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455076
- Sponsor's protocol ID
- IRB00080596
- Status last verified
- May 2019
- First submitted
- 14 May 2015
- Last updated
- 20 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fayfman M, Galindo RJ, Rubin DJ, Mize DL, Anzola I, Urrutia MA, Ramos C, Pasquel FJ, Haw JS, Vellanki P, Wang H, Albury BS, Weaver R, Cardona S, Umpierrez GE. A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes. Diabetes Care. 2019 Mar;42(3):450-456. doi: 10.2337/dc18-1760. Epub 2019 Jan 24.
PubMed 30679302
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02455076
- Acronym / sponsor ID
- IRB00080596
- Conditions
- Type 2 Diabetes
- Keywords
- Hypoglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exenatide inpatient | Active comparator | Drug: ExenatidePatients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide (Byetta®) twice daily. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. |
| Exenatide plus glargine insulin inpatient | Active comparator | Drug: Exenatide, Drug: GlarginePatients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide twice daily and glargine once daily. Glargine insulin will be given once daily at the same time. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. |
| Basal bolus regimen inpatient | Active comparator | Drug: Glargine, Drug: Rapid-acting insulin analogsPatients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive the Basal Bolus Regimen with Glargine and Rapid-Acting Insulin Analogs. Patients treated with insulin previously will receive 80% of total home daily insulin dose as the basal bolus. Half of the total daily dose will be given as glargine and half as rapid-acting insulin analogs. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. |
| Exenatide outpatient | Active comparator | Drug: ExenatidePatients with Type 2 Diabetes treated with diet, oral antidiabetic drugs, or with low-dose insulin will receive exenatide (Byetta®) twice daily. Supplemental (correction) doses of rapid-acting insulin analogs will be given for blood glucose levels > 140 mg/dL per the sliding scale. |
| Insulin Only | Active comparator | Drug: Glargine, Drug: Rapid-acting insulin analogsPatients with Type 2 Diabetes will be treated with Insulin only |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: ByettaExenatide 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. | Drug | Exenatide inpatient, Exenatide outpatient, Exenatide plus glargine insulin inpatient |
| GlargineAlso: LantusGlargine 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. 1. FBG >180 mg/dL, no hypoglycemia; glargine increased by 4 IU. 2. FBG >140 mg/dL, no hypoglycemia; glargine increased by 2 IU. 3. FBG 100-140 mg/dL, no hypoglycemia; no change in dosage. 4. FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD. 5. FBG or RBG < 70 mg/dl, decrease glargine by 8 IU or 20% of TDD. 6. FBG or RBG < 40 mg/dl, decrease dose of glargine by 30%. | Drug | Basal bolus regimen inpatient, Exenatide plus glargine insulin inpatient, Insulin Only |
| Rapid-acting insulin analogsIf 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. | Drug | Basal bolus regimen inpatient, Insulin Only |
Primary outcome
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).
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.
28 secondary outcomes
Mean Fasting Blood Glucose Levels Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days.
Mean Premeal Blood Glucose Levels Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Incidence of Hypoglycemic Events Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Incidence of Hyperglycemic Events Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Total Daily Dose of Insulin Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Average Number of Days of Hospital Stay
Time frame: Duration of hospital stay, an expected average of 10 days
Incidence of the Need for ICU Care Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Hospital Mortality
Time frame: Duration of hospital stay, an expected average of 10 days
Hospital Complications
Time frame: Duration of hospital stay, an expected average of 10 days
Incidence of Acute Kidney Injury Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Incidence of Gastrointestinal Adverse Events Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Number of Patients With Severe Hypoglycemic Events Inpatient
Time frame: Duration of hospital stay, an expected average of 10 days
Incidence of Hospital Readmissions
Time frame: 12 weeks after discharge
Mean Fasting Blood Glucose Levels During Outpatient Period
Time frame: 12 weeks after discharge
Mean Daily Blood Glucose Concentration During Outpatient Period
Time frame: 12 weeks after discharge
The Number of Patients With Hypoglycemia Outpatient
Time frame: 12 weeks after discharge
Number of Patients With Severe Hypoglycemic Events
Time frame: 12 weeks after discharge
Change in Body Weight
Time frame: Time of discharge, 12 weeks after discharge
Change in Body Mass Index
Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge
Number of Patients Who Had Emergency Room Visits
Time frame: 12 weeks after discharge
Number of Hospital Readmissions
Time frame: 12 weeks after discharge
Number of Acute Kidney Injury Events
Time frame: 12 weeks from discharge.
Number of Severe Gastrointestinal Adverse Events
Time frame: 12 weeks from discharge.
Change in Systolic Blood Pressure
Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge
Change in Heart Rate
Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge
Efficacy, Measured by HbA1c Levels and no Weight Gain
Time frame: 12 weeks from discharge.
Efficacy, Measured by HbA1c Levels and no Hypoglycemia
Time frame: 12 weeks from discharge.
Change in Diastolic Blood Pressure
Time frame: Discharge (after day 10 or hospital stay), 12 weeks after discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30679302Fayfman M, Galindo RJ, Rubin DJ, Mize DL, Anzola I, Urrutia MA, Ramos C, Pasquel FJ, Haw JS, Vellanki P, Wang H, Albury BS, Weaver R, Cardona S, Umpierrez GE. A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes. Diabetes Care. 2019 Mar;42(3):450-456. doi: 10.2337/dc18-1760. Epub 2019 Jan 24.
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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo E Umpierrez, MD, CDE principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exenatide, Glargine and Rapid-acting insulin analogs in people with Type 2 Diabetes, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Daily Blood Glucose Concentration Inpatient (time frame: Duration of hospital stay, an expected average of 10 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.