Type 1 Diabetes MellitusNCT02882737
The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
A study testing Glucagon before exercise, Glucagon after exercise and Glucagon after resting in people with Type 1 Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
This project is part of several studies exploring situations, where glucagon potential has lesser glucose elevating effect. Exercise can be one of these situations as exercise may reduce liver glycogen depots. The investigators aims are: 1. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Glucagon before exercise, Glucagon after exercise and Glucagon after resting
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to 11 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 Diabetes ≥ 2 year
- BMI 20-30 kg/m2
- Insulin pump ≥ 1 year.
- HbA1c < 69 mmol/mol (8.5 %)
- Hypoglycemia awareness (reported by Gold et al.)
- Use of carbohydrate counting and the insulin pump bolus calculator for all meals
- Sedentary or mild physical activity: Less than 150 minutes of moderate-intensity aerobic physical activity throughout the week and less than 75 minutes of vigorous-intensity aerobic physical activity throughout the week .
Who cannot join
- Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK)
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Known or suspected alcohol or drug abuse
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Show all 11Show fewer
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Inability to understand the patient information and to give informed consent
- Physical or mental incapacity to perform exercise
- Chronic use or unable to stop acetaminophen (paracetamol) use
- Allergy to the patch of CGM
Trial locations and contacts
1 site in 1 country.
About this study
This project is part of several studies exploring situations, where glucagon potential has lesser glucose elevating effect. Exercise can be one of these situations as exercise may reduce liver glycogen depots.
The investigators aims are:
- To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes.
- To determine whether a subcutaneous glucagon injection just before exercise has a greater impact on hepatic glucose production and thereby is superior to an injection after exercise in preventing hypoglycemia during and two hours after exercise.
- To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at either the abdominal wall or on the upper arm.
Read the detailed description
Design:
A randomized placebo-controlled single-blinded study will be conducted. The subjects do not know if they get glucagon or placebo but the investigator know if the subject get glucagon or placebo. Study participants have to complete three study days and serve as their own controls. After participants have given an informed consent, they will go through three steps:
- Screening day
- Run-in period
- Three study days in a random order:
- Exercise and glucagon injected after cycling/or during cycling in case of hypoglycemia
- Resting and glucagon after resting
- Exercise and glucagon subcutaneous before cycling
47-49 hours before the study visits one CGM device is placed on the abdominal wall on the participant at least 7 cm from the site of the insulin pump infusion set. One CGM is placed on the non-dominant upper arm between 10 cm from elbow and 10 cm from shoulder on the posterior/lateral side on the arm. The CGMs will be in place for seven days. The CGM readings on the CGM placed at the abdominal wall are not blinded for the participant. The CGM readings on the CGM placed on the arm is blinded for the participant. In the period from the study visits to 4 days after the study visits the participant will do self-monitoring of blood glucose 8 times a day on standardized times.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Glucagon before exercise, Glucagon after exercise, Glucagon after resting
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon before exerciseDrug
Glucagon after exerciseDrug
Glucagon after restingDrug
| Study group | Role | What they receive |
|---|---|---|
| Exercise and glucagon before exercise | Experimental | 120 minutes after breakfast; a single subcutaneous bolus of 200µg glucagon is administered by the primary investigator. However, the patient do, not know whether placebo or a glucagon injection is administered.
Exercise: Immediately thereafter, the patient will bicycle for 45 minutes at 50% of the heart rate HR reserve.
When exercise is ended a single subcutaneous bolus of 0.2 ml saline is administered and the exercise session will be suspended. Again, the patient do not know whether placebo or a glucagon is administered. Receives: Drug: Glucagon before exercise |
| Exercise and glucagon after exercise | Active comparator | 120 minutes after breakfast; a single subcutaneous bolus of 0.2 ml saline is administered by the primary investigator. However, the patient do, not know whether placebo or a glucagon injection is administered.
Exercise: Immediately thereafter, the patient will bicycle for 45 minutes at 50% of the heart rate HR reserve.
Low-dose glucagon phase: When exercise is ended or when hypoglycemia occurs (≤3.9 mmol/l); a single subcutaneous bolus of 200μg glucagon is administered and the exercise session will be suspended. Again, the patient do not know whether placebo or a glucagon is administered. Receives: Drug: Glucagon after exercise |
| Resting and glucagon after resting | Active comparator | 120 minutes after breakfast; a single subcutaneous bolus of 200μg placebo is administered.
Resting: After placebo injection the patient will be resting on a hospital bed for 45 minutes. The patient do not know if placebo or glucagon is administered.
Low-dose glucagon phase: After 45 minutes of resting or when hypoglycemia occurs, a single subcutaneous bolus of 200μg glucagon is administered.
Safety issues: If plasma glucose drops < 2.5 mmol/l at two consecutive measurements with 5 min interval or the patient experiences unbearable symptoms of hypoglycemia even after glucagon administration, 20 g carbohydrate is given orally. If plasma glucose drops< 2.3 mmol/l or doesn't raise sufficient after oral glucose, we will give intravenøs glucose to the patient. The study will then end and a new study day will be planned. Receives: Drug: Glucagon after resting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is peak plasma glucose achieved within 2 hours after the 200 μg subcutaneous glucagon injection. In the primary analysis, the investigators will compare the peak plasma glucose after exercise and after resting.
Measured: 2 hours
Secondary outcomes (24)
The time-to-peak value after glucagon injection.
Measured: 2 hours
Duration of the glucagon effect; equal to the time point from glucagon injection to when plasma glucose is below baseline.
Measured: 2 hours
The glycaemic effect, calculated as the total area under the curve (tAUC) after each glucagon injection.
Measured: 2 hours
Changes in plasma ketone bodies after each glucagon injection.
Measured: 2 hours
Changes in plasma lactic acid after each glucagon injection
Measured: 2 hours
Changes in plasma glucagon after each glucagon injection
Measured: 2 hours
Changes in serum free fatty acid (FFA) after each glucagon injection
Measured: 2 hours
Changes in serum triglycerides after each glucagon injection
Measured: 2 hours
Number of events of hypoglycemia (plasma glucose ≤3.9 mmol/l) in the three study days.
Measured: 3 hours
Number of re-events of hypoglycemia (plasma glucose ≤3.9 mmol/l) 30 minutes after first event in the three study groups.
Measured: 30 minutes
Number of rebound hyperglycemia (plasma glucose ≥10.0 mmol/l).
Measured: 4 hours
Mean absolute difference (MARD) in the two CGM sites during the four days after the study day using the daily 8 prespecified plasma glucose measurements by Bayer Contour Link as the reference value.
Measured: 4 days
Mean absolute relative difference (MARD) during the study visits between the two sensor sites with the YSI 2300 STAT PLUS as the reference value.
Measured: 6 hours
MARD during the hypoglycemia range (≤3.9 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value.
Measured: 6 hours
MARD during the euglycemia range (>3.9 mmol/l and < 10.0 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference.
Measured: 6 hours
MARD during the hyperglycemia range (≥10.0 mmol/l) of the study visits for the two Dexcom G4 sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value
Measured: 6 hours
MARD for the two sensor sites (CGMarm and CGMabdomen) from day 1- 7 with the Bayer Contour Link as the reference value.
Measured: 7 days
The rate-of change (ROC) of the two sensors.
Measured: 6 hours
The rate-of change (ROC) of plasma glucose measured by the YSI 2300 STAT PLUS.
Measured: 6 hours
The Precision Absolute Relative Difference (=CGM readings of one system will be subtracted from CGM readings of the other system, and this difference will be divided by the average of the CGM readings of the abdominal sensors.)
Measured: 7 days
The sensors' sensitivity and specificity to detect a hypoglycemic event.
Measured: 7 days
The point accuracy of both sensors with the Clarke error grid analysis
Measured: 7 days
The pressure induced sensor attenuation (PISA) by using a recent fault detection algorithm that can detect non-physiologic anomalous low sensor readings.
Measured: 7 days
The fused data from the two sensors.
Fused data will be compared with data from individual sensors
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion11 Jul 2017
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Principal investigator, Isabelle Steineck, Hvidovre University Hospital
- Investigators
- Isabelle Steineck, MD, Principal investigator, Hvidovre Hospital department of endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882737
- Sponsor's protocol ID
- 16016762
- Status last verified
- Sep 2016
- First submitted
- 17 Aug 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data are processed and merged into at least two scientific articles published in international peer-reviewed scientific journal. Positive, negative and inconclusive results will be published as soon as scientifically justifiable. The study protocol will be published at www.clinicaltrial.gov. The results from the study will within 1 year be published on EudraCT. The sponsor will contact the Danish Health and Medicines Authority within 90 days after the study is ended and to inform them that the study has ended
Publications
Steineck IIK, Ranjan A, Schmidt S, Clausen TR, Holst JJ, Norgaard K. Preserved glucose response to low-dose glucagon after exercise in insulin-pump-treated individuals with type 1 diabetes: a randomised crossover study. Diabetologia. 2019 Apr;62(4):582-592. doi: 10.1007/s00125-018-4807-8. Epub 2019 Jan 14.
PubMed 30643924
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02882737
- Acronym / sponsor ID
- 16016762
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- Sep 2016
- Primary completion
- 11 Jul 2017 (actual)
- Study completion
- 11 Jul 2017 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is part of several studies exploring situations, where glucagon potential has lesser glucose elevating effect. Exercise can be one of these situations as exercise may reduce liver glycogen depots.
The investigators aims are:
- To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes.
- To determine whether a subcutaneous glucagon injection just before exercise has a greater impact on hepatic glucose production and thereby is superior to an injection after exercise in preventing hypoglycemia during and two hours after exercise.
- To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at either the abdominal wall or on the upper arm.
Detailed description
Design:
A randomized placebo-controlled single-blinded study will be conducted. The subjects do not know if they get glucagon or placebo but the investigator know if the subject get glucagon or placebo. Study participants have to complete three study days and serve as their own controls. After participants have given an informed consent, they will go through three steps:
- Screening day
- Run-in period
- Three study days in a random order:
- Exercise and glucagon injected after cycling/or during cycling in case of hypoglycemia
- Resting and glucagon after resting
- Exercise and glucagon subcutaneous before cycling
47-49 hours before the study visits one CGM device is placed on the abdominal wall on the participant at least 7 cm from the site of the insulin pump infusion set. One CGM is placed on the non-dominant upper arm between 10 cm from elbow and 10 cm from shoulder on the posterior/lateral side on the arm. The CGMs will be in place for seven days. The CGM readings on the CGM placed at the abdominal wall are not blinded for the participant. The CGM readings on the CGM placed on the arm is blinded for the participant. In the period from the study visits to 4 days after the study visits the participant will do self-monitoring of blood glucose 8 times a day on standardized times.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise and glucagon before exercise | Experimental | Drug: Glucagon before exercise120 minutes after breakfast; a single subcutaneous bolus of 200µg glucagon is administered by the primary investigator. However, the patient do, not know whether placebo or a glucagon injection is administered. Exercise: Immediately thereafter, the patient will bicycle for 45 minutes at 50% of the heart rate HR reserve. When exercise is ended a single subcutaneous bolus of 0.2 ml saline is administered and the exercise session will be suspended. Again, the patient do not know whether placebo or a glucagon is administered. |
| Exercise and glucagon after exercise | Active comparator | Drug: Glucagon after exercise120 minutes after breakfast; a single subcutaneous bolus of 0.2 ml saline is administered by the primary investigator. However, the patient do, not know whether placebo or a glucagon injection is administered. Exercise: Immediately thereafter, the patient will bicycle for 45 minutes at 50% of the heart rate HR reserve. Low-dose glucagon phase: When exercise is ended or when hypoglycemia occurs (≤3.9 mmol/l); a single subcutaneous bolus of 200μg glucagon is administered and the exercise session will be suspended. Again, the patient do not know whether placebo or a glucagon is administered. |
| Resting and glucagon after resting | Active comparator | Drug: Glucagon after resting120 minutes after breakfast; a single subcutaneous bolus of 200μg placebo is administered. Resting: After placebo injection the patient will be resting on a hospital bed for 45 minutes. The patient do not know if placebo or glucagon is administered. Low-dose glucagon phase: After 45 minutes of resting or when hypoglycemia occurs, a single subcutaneous bolus of 200μg glucagon is administered. Safety issues: If plasma glucose drops < 2.5 mmol/l at two consecutive measurements with 5 min interval or the patient experiences unbearable symptoms of hypoglycemia even after glucagon administration, 20 g carbohydrate is given orally. If plasma glucose drops< 2.3 mmol/l or doesn't raise sufficient after oral glucose, we will give intravenøs glucose to the patient. The study will then end and a new study day will be planned. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Type 1 Diabetes ≥ 2 year
- BMI 20-30 kg/m2
- Insulin pump ≥ 1 year.
- HbA1c < 69 mmol/mol (8.5 %)
- Hypoglycemia awareness (reported by Gold et al.)
Key exclusion criteria (11 listed)
- Allergy or intolerance to lactose or GlucaGen® (Novo Nordisk, Bagsværd, DK)
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- Use of anti-diabetic medicine (other than insulin), per oral corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Known or suspected alcohol or drug abuse
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 |
|---|---|---|
| Glucagon before exercise | Drug | Exercise and glucagon before exercise |
| Glucagon after exercise | Drug | Exercise and glucagon after exercise |
| Glucagon after resting | Drug | Resting and glucagon after resting |
Primary outcome
The primary endpoint is peak plasma glucose achieved within 2 hours after the 200 μg subcutaneous glucagon injection. In the primary analysis, the investigators will compare the peak plasma glucose after exercise and after resting.
Time frame: 2 hours
24 secondary outcomes
The time-to-peak value after glucagon injection.
Time frame: 2 hours
Duration of the glucagon effect; equal to the time point from glucagon injection to when plasma glucose is below baseline.
Time frame: 2 hours
The glycaemic effect, calculated as the total area under the curve (tAUC) after each glucagon injection.
Time frame: 2 hours
Changes in plasma ketone bodies after each glucagon injection.
Time frame: 2 hours
Changes in plasma lactic acid after each glucagon injection
Time frame: 2 hours
Changes in plasma glucagon after each glucagon injection
Time frame: 2 hours
Changes in serum free fatty acid (FFA) after each glucagon injection
Time frame: 2 hours
Changes in serum triglycerides after each glucagon injection
Time frame: 2 hours
Number of events of hypoglycemia (plasma glucose ≤3.9 mmol/l) in the three study days.
Time frame: 3 hours
Number of re-events of hypoglycemia (plasma glucose ≤3.9 mmol/l) 30 minutes after first event in the three study groups.
Time frame: 30 minutes
Number of rebound hyperglycemia (plasma glucose ≥10.0 mmol/l).
Time frame: 4 hours
Mean absolute difference (MARD) in the two CGM sites during the four days after the study day using the daily 8 prespecified plasma glucose measurements by Bayer Contour Link as the reference value.
Time frame: 4 days
Mean absolute relative difference (MARD) during the study visits between the two sensor sites with the YSI 2300 STAT PLUS as the reference value.
Time frame: 6 hours
MARD during the hypoglycemia range (≤3.9 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value.
Time frame: 6 hours
MARD during the euglycemia range (>3.9 mmol/l and < 10.0 mmol/l) of the study visits between the two sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference.
Time frame: 6 hours
MARD during the hyperglycemia range (≥10.0 mmol/l) of the study visits for the two Dexcom G4 sensor sites (CGMarm vs. CGMabdomen) with the YSI 2300 STAT PLUS as the reference value
Time frame: 6 hours
MARD for the two sensor sites (CGMarm and CGMabdomen) from day 1- 7 with the Bayer Contour Link as the reference value.
Time frame: 7 days
The rate-of change (ROC) of the two sensors.
Time frame: 6 hours
The rate-of change (ROC) of plasma glucose measured by the YSI 2300 STAT PLUS.
Time frame: 6 hours
The Precision Absolute Relative Difference (=CGM readings of one system will be subtracted from CGM readings of the other system, and this difference will be divided by the average of the CGM readings of the abdominal sensors.)
Time frame: 7 days
The sensors' sensitivity and specificity to detect a hypoglycemic event.
Time frame: 7 days
The point accuracy of both sensors with the Clarke error grid analysis
Time frame: 7 days
The pressure induced sensor attenuation (PISA) by using a recent fault detection algorithm that can detect non-physiologic anomalous low sensor readings.
Time frame: 7 days
The fused data from the two sensors.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Derived from this study: PubMed 30643924Steineck IIK, Ranjan A, Schmidt S, Clausen TR, Holst JJ, Norgaard K. Preserved glucose response to low-dose glucagon after exercise in insulin-pump-treated individuals with type 1 diabetes: a randomised crossover study. Diabetologia. 2019 Apr;62(4):582-592. doi: 10.1007/s00125-018-4807-8. Epub 2019 Jan 14.
- Individual participant dataSharing planned: Yes. Data are processed and merged into at least two scientific articles published in international peer-reviewed scientific journal. Positive, negative and inconclusive results will be published as soon as scientifically justifiable. The study protocol will be published at www.clinicaltrial.gov. The results from the study will within 1 year be published on EudraCT. The sponsor will contact the Danish Health and Medicines Authority within 90 days after the study is ended and to inform them that the study has ended
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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.
Isabelle Steineck, MD principal investigator
Hvidovre Hospital department of endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon before exercise, Glucagon after exercise and Glucagon after resting in people with Type 1 Diabetes Mellitus, run by Hvidovre University Hospital at 1 site in Denmark.
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 7 inclusion and 11 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 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is peak plasma glucose achieved within 2 hours after the 200 μg subcutaneous glucagon injection. In the primary analysis, the investigators will compare the peak plasma glucose after exercise and after resting. (time frame: 2 hours). 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 NCT02882737, 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 24 Jul 2017.