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

May 28, 2019 updated by: Guillermo Umpierrez, MD, Emory University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Exenatide
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
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.
Drug: Exenatide
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
Drug: Glargine

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.

  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%.
Other Names:
  • Lantus
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.
Drug: Glargine

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.

  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%.
Other Names:
  • Lantus
Drug: Rapid-acting insulin analogs
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.
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.
Drug: Exenatide
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
Active Comparator: Insulin Only
Patients with Type 2 Diabetes will be treated with Insulin only
Drug: Glargine

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.

  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%.
Other Names:
  • Lantus
Drug: Rapid-acting insulin analogs
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Duration of hospital stay, an expected average of 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.
12 weeks from discharge.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
The blood glucose levels prior to each meal will using a glucose meter.
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
The number of patients with hypoglycemia (blood glucose levels < 70 mg/dL) will be recorded.
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
Percent of readings with hyperglycemia (blood glucose levels > 240 mg/dL)
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
The total daily dose of insulin needed for glycemic control from baseline through the patient's hospital stay will be recorded.
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
The average number of days in the hospital for subjects will be calculated.
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
The total number of patients who require transfer to the ICU will be recorded.
Duration of hospital stay, an expected average of 10 days
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.
Duration of hospital stay, an expected average of 10 days
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.
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
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.
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
The number of subjects who experience gastrointestinal side effects including nausea, vomiting and diarrhea will be recorded.
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
Occurrences of hypoglycemia (blood glucose levels < 40 mg/dL) will be recorded.
Duration of hospital stay, an expected average of 10 days
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.
12 weeks after discharge
Mean Fasting Blood Glucose Levels During Outpatient Period
Time Frame: 12 weeks after discharge
Fasting Blood Glucose Levels were measured using blood test
12 weeks after discharge
Mean Daily Blood Glucose Concentration During Outpatient Period
Time Frame: 12 weeks after discharge
Mean Daily Blood Glucose Concentration will be calculated and recorded.
12 weeks after discharge
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
12 weeks after discharge
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
12 weeks after discharge
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
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
The change in BMI from discharge to 12 weeks after discharge will be calculated
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
The number of patients who had emergency room visits from the time of discharge to 12 weeks after discharge will be recorded.
12 weeks after discharge
Number of Hospital Readmissions
Time Frame: 12 weeks after discharge
Number of hospital readmissions during 12 weeks after discharge will be recorded
12 weeks after discharge
Number of Acute Kidney Injury Events
Time Frame: 12 weeks from discharge.
Number of Acute Kidney Injury events will be recorded
12 weeks from discharge.
Number of Severe Gastrointestinal Adverse Events
Time Frame: 12 weeks from discharge.
Number of Severe (require hospitalization) Gastrointestinal Adverse Events
12 weeks from discharge.
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
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
Change in heart rate from the time of discharge to 12 weeks after discharge will be recorded
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.
Number of patients who have an HbA1c <7.0% and no weight gain at 12 weeks from discharge will be recorded.
12 weeks from discharge.
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.
12 weeks from discharge.
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
Discharge (after day 10 or hospital stay), 12 weeks after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillermo E Umpierrez, MD, CDE, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00080596

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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