Phase 4
N=150
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
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02455076 ↗Enrolled (actual)
150
Serious AEs
19.4%
Results posted
Jun 2019
Primary outcome: Primary: Mean Daily Blood Glucose Concentration Inpatient — 177.1; 154.1; 166.1 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Exenatide (Drug); Glargine (Drug); Rapid-acting insulin analogs (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daily Blood Glucose Concentration Inpatient |
177.1; 154.1; 166.1 | — |
| PRIMARY Change in HbA1c Concentration Inpatient |
-1.3; -1.1; -1.4 | — |
| SECONDARY Mean Fasting Blood Glucose Levels Inpatient |
177.1; 146.8; 157.7 | — |
| SECONDARY Mean Premeal Blood Glucose Levels Inpatient |
178.7; 153.4; 161.8 | — |
| SECONDARY Incidence of Hypoglycemic Events Inpatient |
0; 3; 6 | — |
| SECONDARY Incidence of Hyperglycemic Events Inpatient |
10.4; 5.1; 11.2 | — |
| SECONDARY Total Daily Dose of Insulin Inpatient |
8.1; 17.7; 28 | — |
| SECONDARY Average Number of Days of Hospital Stay |
4; 5; 4 | — |
| SECONDARY Incidence of the Need for ICU Care Inpatient |
2; 3; 0 | — |
| SECONDARY Hospital Mortality |
0; 0; 0 | — |
| SECONDARY Hospital Complications |
4; 6; 3 | — |
| SECONDARY Incidence of Acute Kidney Injury Inpatient |
3; 6; 3 | — |
| SECONDARY Incidence of Gastrointestinal Adverse Events Inpatient |
5; 5; 1 | — |
| SECONDARY Number of Patients With Severe Hypoglycemic Events Inpatient |
0; 0; 0 | — |
| SECONDARY Incidence of Hospital Readmissions |
4; 16; 6 | — |
| SECONDARY Mean Fasting Blood Glucose Levels During Outpatient Period |
146.5; 133.2 | — |
| SECONDARY Mean Daily Blood Glucose Concentration During Outpatient Period |
155.1; 144.7 | — |
| SECONDARY The Number of Patients With Hypoglycemia Outpatient |
7; 7 | — |
| SECONDARY Number of Patients With Severe Hypoglycemic Events |
1; 4 | — |
| SECONDARY Change in Body Weight |
-2.3; -1.2 | — |
| SECONDARY Change in Body Mass Index |
-0.8; -0.7 | — |
| SECONDARY Number of Patients Who Had Emergency Room Visits |
4; 12 | — |
| SECONDARY Number of Hospital Readmissions |
12; 14 | — |
| SECONDARY Number of Acute Kidney Injury Events |
1; 1 | — |
| SECONDARY Number of Severe Gastrointestinal Adverse Events |
1; 1 | — |
| SECONDARY Change in Systolic Blood Pressure |
3.2; 1.8 | — |
| SECONDARY Change in Heart Rate |
-3.1; 0.2 | — |
| SECONDARY Efficacy, Measured by HbA1c Levels and no Weight Gain |
8; 5 | — |
| SECONDARY Efficacy, Measured by HbA1c Levels and no Hypoglycemia |
11; 8 | — |
| SECONDARY Change in Diastolic Blood Pressure |
4.2; -1.0 | — |
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.
Eligibility Criteria
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 25 Kg/m^2 and 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 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 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.
Data sourced from ClinicalTrials.gov (NCT02455076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.