Primary outcomeMean· Duration of hospital stay, an expected average of 10 days.
Mean Daily Blood Glucose Concentration Inpatient
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | 177.1 | 41 |
| Exenatide Plus Glargine Insulin | 154.1 | 39 |
| Basal Bolus Regimen | 166.1 | 40 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataExenatide 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
NCTNCT02455076 (opens ClinicalTrials.gov in a new tab)Other idIRB00080596
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 150 participants (actual)
- Sponsor
- Emory University · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Sept 2015
- Primary completion
- Mar 2018
- Completion
- Mar 2018
- First posted
- 27 May 2015 (estimated)
- Last update posted
- 20 Jun 2019
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20152016201720182019
- Ph 4
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
NCT02455076Sept 2015 to Mar 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- ExenatideDrug
- GlargineDrug
- Rapid-acting insulin analogsDrug
Arms5
Active comparator
Exenatide inpatient
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.
Active comparator
Exenatide plus glargine insulin inpatient
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.
Active comparator
Basal bolus regimen inpatient
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.
Active comparator
Exenatide outpatient
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.
Active comparator
Insulin Only
Patients with Type 2 Diabetes will be treated with Insulin only
Primary outcomes2
Outcomes the sponsor listed as primary.
Mean Daily Blood Glucose Concentration Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days.
Registry description
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.
Registry description
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(20)
Mean Fasting Blood Glucose Levels Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days.
Registry description
The blood glucose levels prior to the patient's first meal of the day will be assessed using a glucose meter.
Mean Premeal Blood Glucose Levels Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The blood glucose levels prior to each meal will using a glucose meter.
Incidence of Hypoglycemic Events Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The number of patients with hypoglycemia (blood glucose levels \< 70 mg/dL) will be recorded.
Incidence of Hyperglycemic Events Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
Percent of readings with hyperglycemia (blood glucose levels \> 240 mg/dL)
Total Daily Dose of Insulin Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.
Average Number of Days of Hospital Stay
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The average number of days in the hospital for subjects will be calculated.
Incidence of the Need for ICU Care Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The total number of patients who require transfer to the ICU will be recorded.
Hospital Mortality
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The total number of subject deaths during hospital stay will be recorded.
Hospital Complications
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
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.
Incidence of Acute Kidney Injury Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
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.
Incidence of Gastrointestinal Adverse Events Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.
Number of Patients With Severe Hypoglycemic Events Inpatient
Time frame · Duration of hospital stay, an expected average of 10 days
Registry description
Occurrences of hypoglycemia (blood glucose levels \< 40 mg/dL) will be recorded.
Incidence of Hospital Readmissions
Time frame · 12 weeks after discharge
Registry description
The number of patients who require readmission to the hospital from the time of discharge to 12 weeks after discharge will be recorded.
Mean Fasting Blood Glucose Levels During Outpatient Period
Time frame · 12 weeks after discharge
Registry description
Fasting Blood Glucose Levels were measured using blood test
Mean Daily Blood Glucose Concentration During Outpatient Period
Time frame · 12 weeks after discharge
Registry description
Mean Daily Blood Glucose Concentration will be calculated and recorded.
The Number of Patients With Hypoglycemia Outpatient
Time frame · 12 weeks after discharge
Registry description
Occurrence of hypoglycemia (blood glucose levels \< 70 mg) will be identified by blood test
Number of Patients With Severe Hypoglycemic Events
Time frame · 12 weeks after discharge
Registry description
Occurrences of hypoglycemia (blood glucose levels \< 40 mg/dL) will be detected by blood test
Change in Body Weight
Time frame · Time of discharge, 12 weeks after discharge
Registry description
The change in Body Weight from discharge to 12 weeks after discharge will be recorded
Change in Body Mass Index
Time frame · Discharge (after day 10 or hospital stay), 12 weeks after discharge 12 weeks after discharge
Registry description
The change in BMI from discharge to 12 weeks after discharge will be calculated
Number of Patients Who Had Emergency Room Visits
Time frame · 12 weeks after discharge
Registry description
The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 12 weeks from discharge.
Change in HbA1c Concentration Inpatient
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Exenatide | -1.3 | 1.5 |
| Exenatide Plus Glargine Insulin | -1.1 | 2.2 |
| Basal Bolus Regimen | -1.4 | 1.1 |
Secondary and other outcome results(6)
Secondary outcomeMean· Duration of hospital stay, an expected average of 10 days.
Mean Fasting Blood Glucose Levels Inpatient
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | 177.1 | 46.8 |
| Exenatide Plus Glargine Insulin | 146.8 | 39.7 |
| Basal Bolus Regimen | 157.7 | 47.0 |
Secondary outcomeMean· Duration of hospital stay, an expected average of 10 days
Mean Premeal Blood Glucose Levels Inpatient
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Exenatide | 178.7 | 42.8 |
| Exenatide Plus Glargine Insulin | 153.4 | 39.4 |
| Basal Bolus Regimen | 161.8 | 42.1 |
Secondary outcomeCount of participants· Duration of hospital stay, an expected average of 10 days
Incidence of Hypoglycemic Events Inpatient
| Group | Value (Participants) |
|---|---|
| Exenatide | 0 |
| Exenatide Plus Glargine Insulin | 3 |
| Basal Bolus Regimen | 6 |
Secondary outcomeMean· Duration of hospital stay, an expected average of 10 days
Incidence of Hyperglycemic Events Inpatient
| Group | Value (percentage of readings) | Spread |
|---|---|---|
| Exenatide | 10.4 | 24 |
| Exenatide Plus Glargine Insulin | 5.1 | 16 |
| Basal Bolus Regimen | 11.2 | 23 |
Secondary outcomeMean· Duration of hospital stay, an expected average of 10 days
Total Daily Dose of Insulin Inpatient
| Group | Value (units/day) | Spread |
|---|---|---|
| Exenatide | 8.1 | 5 |
| Exenatide Plus Glargine Insulin | 17.7 | 11 |
| Basal Bolus Regimen | 28 | 15 |
Secondary outcomeMedian· Duration of hospital stay, an expected average of 10 days
Average Number of Days of Hospital Stay
| Group | Value (days) |
|---|---|
| Exenatide | 4 |
| Exenatide Plus Glargine Insulin | 5 |
| Basal Bolus Regimen | 4 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide InpatientExenatide: 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. | 0 / 47 | 7 / 47 | 5 / 47 |
| Exenatide Plus Glargine Insulin InpatientExenatide: 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. Glargine: Glargine will be given once daily, at the same time of day. | 0 / 51 | 12 / 51 | 5 / 51 |
| Basal Bolus Regimen InpatientPatients 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. | 0 / 52 | 8 / 52 | 1 / 52 |
| Exenatide OutpatientExenatide: 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. | 1 / 48 | 11 / 48 | 20 / 48 |
| Insulin Only OutpatientPatients with Type 2 Diabetes treated with Insulin only | 0 / 55 | 11 / 55 | 1 / 55 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2019
13 results
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.
Fayfman et al. 2019Diabetes carecited by 54
PMID 30679302PMC6905476DOI 10.2337/dc18-1760PUB-30679302
Rights unknown13 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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.
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