Diabetes Mellitus, Non-Insulin-DependentPhase 3NCT00035984
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing AC2993 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 100 sites in United States.
Trial summary
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Non-Insulin-Dependent
- What is being tested?
- AC2993
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 734 participants
- Where
- 100 sitesUnited States
- Study dates
- May 2002to Aug 2003
- Phase
- Phase 3
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with Type 2 diabetes mellitus
- Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening
- BMI= 27-45 kg/m2
- HbA1c value between 7.5% and 11%
Who cannot join
- Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening
- Patients treated previously with AC2993
- Patients presently treated with insulin
Trial locations and contacts
100 sites in 1 country.
100 sites in 1 country
United States100 sites
University of Hawaii-Diabetes Research Group
‘Ewa Beach, Hawaii, 96706
Advanced Clinical Research Institute
Anaheim, California, 92801
Pinnacle Research Group
Anniston, Alabama, 36207
Israel A. Hartman, M.D.
Arlington, Texas, 76014
Medical Associates of Northern Virginia
Arlington, Virginia, 22204
Medical Research Unlimited
Aventura, Florida
University of Maryland-Joslin Diabetes Center
Baltimore, Maryland, 21012
University Primary Care Center at Belvidere
Belvidere, Illinois, 61008
Parkway Medical Center
Birmingham, Alabama, 35206
SUNY Downstate
Brooklyn, New York, 11203
Mercury Street Medical
Butte, Montana, 59701
Physicians for Clinical Research
Camp Hill, Pennsylvania
Medical University of South Carolina
Charleston, South Carolina, 29425
Charlotte Clinical Research
Charlotte, North Carolina, 28211
CNS Clinical Trials
Chester, South Carolina, 29706
Diabetes and Endocrinology Specialists
Chesterfield, Missouri, 63017
Northwestern Memorial Physicians Group
Chicago, Illinois, 60602
Illinois Center for Clinical Trials
Chicago, Illinois, 60610
Cook County Hospital
Chicago, Illinois, 60612
Midwest Pharmaceutical Research
City of Saint Peters, Missouri, 63376
Morton Plant Mease Health Care
Clearwater, Florida, 33756
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
Columbus Metabolic Foundation
Columbus, Georgia, 31901
Radiant Research-Columbus
Columbus, Ohio, 43212
East Bay Clinical Trial Center
Concord, California
Dallas Diabetes and Endocrinology Research Center
Dallas, Texas, 75230
Creekside Endocrine Associates
Denver, Colorado, 80209
University of Colorado-Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262
Henry Ford Health System
Detroit, Michigan
UNC Diabetes Care Center
Durham, North Carolina, 27713
Texas Tech University Health Sciences-Internal Medicine
El Paso, Texas, 79905
Medical Group of Encino
Encino, California, 91436
Medical Arts Research Collaborative
Excelsior Springs, Missouri, 64024
First Care Family Doctors
Fayetteville, Arkansas, 72701
Internal Medicine Associates
Fort Myers, Florida
Valley Research
Fresno, California, 93720
St. Joseph Heritage Healthcare
Fullerton, California, 92835
Clin Sci International
Gainesville, Florida, 32605
Grand Rapids Associated Interns
Grand Rapids, Michigan
Unifour Medical Research
Hickory, North Carolina, 28601
American Health Network
Indianapolis, Indiana, 46222
Indiana University Outpatient Clinical Research
Indianapolis, Indiana
North Texas Clinical Research
Irving, Texas, 75038
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Northeast Florida Endocrine & Diabetes Research
Jacksonville, Florida, 32204
Jupiter Research Institute
Jupiter, Florida, 33458
Lipid, Atherosclerosis & Metabolic Clinic
Kansas City, Kansas, 66160
St Lukes Lipid and Diabetes Research Center
Kansas City, Missouri, 64111
Holston Medical Group
Kingsport, Tennessee, 37660
Whittier Institute for Diabetes
La Jolla, California, 92037
Lovelace Scientific Resources-Las Vegas
Las Vegas, Nevada, 89102
Kentucky Diabetes Center
Lexington, Kentucky, 40503
Central Kentucky Research Associates
Lexington, Kentucky, 40509
University of Kentucky Metabolic Research Group
Lexington, Kentucky, 40536-9841
Physicians Group Research Clinic, LLC
Little Rock, Arkansas, 72205
Richard Cherlin, M.D.
Los Gatos, California, 95032
MedResearch, Inc.
Louisville, Kentucky, 40223
University of Wisconsin West Clinic
Madison, Wisconsin, 53711
Medford Medical Clinic
Medford, Oregon, 97504
The Endocrine Clinic
Memphis, Tennessee, 38119
University Mednet
Mentor, Ohio, 44060
Baptist Diabetes Associates
Miami, Florida, 33176
Midwest Endocrinology Associates
Milwaukee, Wisconsin, 53215
International Diabetes Center
Minneapolis, Minnesota, 55416
Extended Arm Physicians/ Southern Drug
Montgomery, Alabama, 36106
Dr. Martinez Medical Clinic
Moreno Valley, California, 92553
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Mid State Endocrine Associates
Nashville, Tennessee, 37203
New Orleans Center for Clinical Research
New Orleans, Louisiana, 70119
Ochsner Clinic
New Orleans, Louisiana, 70121
St. Lukes Roosevelt Hospital
New York, New York, 10025
OU Health Sciences Center
Oklahoma City, Oklahoma, 73104
West Olympia Internal Medicine
Olympia, Washington, 98502
Thomas Jefferson University Diabetes Research Center
Philadelphia, Pennsylvania, 19107
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Philadelphia Health Associates
Philadelphia, Pennsylvania, 19146
Radiant Research
Portland, Oregon
Comprehensive Diabetes-Endocrine Medical Associates
Redwood City, California, 94062
Lisa Abbott, MD
Reno, Nevada, 89502
Rochester Clinical Research
Rochester, New York, 14609
Mid Missouri Research Specialists, Inc.
Rolla, Missouri, 65401
Utah Diabetes Center at the University of Utah
Salt Lake City, Utah, 84108
Salt Lake Research
Salt Lake City, Utah, 84124
University of Texas Health Sciences Center-Texas Diabetes Institute
San Antonio, Texas, 78207
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229-3894
SAM Clinical Research
San Antonio, Texas, 78229
Radiant Research-San Diego
San Diego, California, 92108
Veterans Medical Research Foundation
San Diego, California, 92161
Comprehensive NeuroScience Inc.
Sarasota, Florida, 34232
Rockwood Clinic
Spokane, Washington, 99202
Radiant Research-St. Louis
St Louis, Missouri, 63141
Tallahassee Endocrine Associates
Tallahassee, Florida, 32308
Southern Drug Research Network
Tallassee, Alabama, 36078
Diablo Clinical Research
Walnut Creek, California
Clinica Research Inc.
Waltham, Massachusetts, 02154
Medstar Clinical Research
Washington D.C., District of Columbia, 20003-4393
George Washington University
Washington D.C., District of Columbia, 20037
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401
New Hanover Medical Research Associates
Wilmington, North Carolina, 28412
DOCS at Beth Israel Medical Center
Yonkers, New York, 10710
About this study
Official title: A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea
This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Being tested
- AC2993, Placebo
- Keywords
- Type 2 Diabetes Mellitis
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC2993Drug
Also called synthetic exendin-4
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
AC2993Drug
Also called synthetic exendin-4
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
PlaceboDrug
Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily
PlaceboDrug
Placebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily
| Study group | Role | What they receive |
|---|---|---|
| AC2993 5 mcg (0.02 mL) | Experimental | Placebo, then AC2993 5 mcg, then AC2993 5 mcg Receives: Drug: AC2993 |
| AC2993 10mcg (0.04 mL) | Experimental | Placebo, then AC2993 5 mcg, then AC2993 10 mcg Receives: Drug: AC2993 |
| Placebo 0.02 mL | Placebo comparator | Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL Receives: Drug: Placebo |
| Placebo 0.04 mL | Placebo comparator | Placebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from Baseline to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
Measured: Baseline (Day 1) to Week 30
Secondary outcomes (6)
Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Change in HbA1c from baseline, measured from Visit 3 (Day 1) to each of the intermediate visits (Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, and Week 24)
Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
The number of subjects achieving HbA1c target values of < 7% and < 8% by study termination (Week 30)
Measured: Baseline (Day 1) and Week 30
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by study termination (Week 30)
Measured: Baseline (Day 1), and Week 30
The time to achieve specific HbA1c target values of < 7% and < 8%
The time it takes subjects to achieve HbA1c target values of < 7% and < 8%
Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
The time it takes subjects to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Measured: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
Change in body weight from Baseline to each intermediate visit and Week 30
Change in body weight (kg) from Baseline to each intermediate visit and Week 30
Measured: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2002 (estimated)
- Study startMay 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Non-Insulin-DependentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 734 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035984
- Sponsor's protocol ID
- 2993-115
- Status last verified
- Jan 2015
- First submitted
- 7 May 2002
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005 May;28(5):1083-91. doi: 10.2337/diacare.28.5.1083.
PubMed 15855571Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
PubMed 22913891Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
PubMed 22236356
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Triple-Blind, Parallel-Group, Long-Term, Placebo-Controlled, Multicenter Study to Examine the Effect on Glucose Control (HbA1c) of AC2993 Given Twice Daily in Subjects With Type 2 Diabetes Mellitus Treated With Metformin and a Sulfonylurea
- ClinicalTrials.gov ID
- NCT00035984
- Acronym / sponsor ID
- 2993-115
- Conditions
- Diabetes Mellitus, Non-Insulin-Dependent
- Keywords
- Type 2 Diabetes Mellitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 734 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 8 May 2002 (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 is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin and a sulfonylurea) throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AC2993 5 mcg (0.02 mL) | Experimental | Drug: AC2993Placebo, then AC2993 5 mcg, then AC2993 5 mcg |
| AC2993 10mcg (0.04 mL) | Experimental | Drug: AC2993Placebo, then AC2993 5 mcg, then AC2993 10 mcg |
| Placebo 0.02 mL | Placebo comparator | Drug: PlaceboPlacebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.02 mL |
| Placebo 0.04 mL | Placebo comparator | Drug: PlaceboPlacebo 0.02 mL, then Placebo 0.02 mL, then Placebo 0.04 mL |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with Type 2 diabetes mellitus
- Treated with both metformin and a sulfonylurea at defined doses for at least 3 months prior to screening
- BMI= 27-45 kg/m2
- HbA1c value between 7.5% and 11%
Key exclusion criteria (3 listed)
- Treated with oral anti-diabetic medications other than metformin and sulfonylurea within 3 months of screening
- Patients treated previously with AC2993
- Patients presently treated with insulin
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 |
|---|---|---|
| AC2993Also: synthetic exendin-4Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily | Drug | AC2993 5 mcg (0.02 mL) |
| AC2993Also: synthetic exendin-4Placebo Lead In (0.02 mL) for 4 weeks / AC2993 5 mcg (0.02 mL) for 4 weeks / AC2993 10 mcg (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily | Drug | AC2993 10mcg (0.04 mL) |
| PlaceboPlacebo Lead In (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 4 weeks / AC2993 5mcg (0.02 mL) for 26 weeks - All are subcutaneously injected twice daily | Drug | Placebo 0.02 mL |
| PlaceboPlacebo Lead In (0.02 mL) for 4 weeks / Placebo mcg (0.02 mL) for 4 weeks / Placebo (0.04 mL) for 26 weeks - All are subcutaneously injected twice daily | Drug | Placebo 0.04 mL |
Primary outcome
Change in HbA1c from Baseline to Week 30
Time frame: Baseline (Day 1) to Week 30
Change in HbA1c from Baseline (Day 1) to study termination (Week 30)
6 secondary outcomes
Change in HbA1c from baseline (Day 1) to each of the intermediate visits
Time frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24
The number of subjects achieving HbA1c target values of < 7% and < 8% by Week 30
Time frame: Baseline (Day 1) and Week 30
The number of subjects achieving HbA1c reductions of > 0.5% and > 1.0% by Week 30
Time frame: Baseline (Day 1), and Week 30
The time to achieve specific HbA1c target values of < 7% and < 8%
Time frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
The time to achieve HbA1c reductions of 0.5% or more and >1.0% or more
Time frame: Baseline (Day 1), Week 2, Week 4, Week 6, Week 12, Week 18, Week 24, Week 30
Change in body weight from Baseline to each intermediate visit and Week 30
Time frame: Baseline (Day 1), Week 2, Week 4, Week, 6, Week 12, Week 18, Week 24, Week 30
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 Feb 2015.
- Results publication: PubMed 15855571Kendall DM, Riddle MC, Rosenstock J, Zhuang D, Kim DD, Fineman MS, Baron AD. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005 May;28(5):1083-91. doi: 10.2337/diacare.28.5.1083.
- Derived from this study: PubMed 22913891Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
- Derived from this study: PubMed 22236356Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
100 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AC2993 in people with Diabetes Mellitus, Non-Insulin-Dependent, run by AstraZeneca at 100 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 4 inclusion and 3 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 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 100 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in HbA1c from Baseline to Week 30 (time frame: Baseline (Day 1) to Week 30). 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 NCT00035984, which also lists 3 linked publications.
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 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.