Male Subjects With Type II Diabetes (T2DM)Phase 1NCT02935712
Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)
A Phase 1 study of Male Subjects With Type II Diabetes (T2DM), run by AstraZeneca at 1 site in Germany.
Trial summary
This study will be a phase I, first time in human (FiH), randomized, single-blind, placebo-controlled, SAD study in male patients with T2DM, performed at a single study center. The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65 years will be included Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Male Subjects With Type II Diabetes (T2DM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- 16 Dec 2016to 8 Jan 2018
- Phase
- Phase 1
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Male patients with mild T2DM aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 20 and 35 kg/m2 inclusive and weigh at least 50 kg.
- Able to understand, read and speak the German language.
- T2DM diagnosis for at least 1 year at the time of the screening visit.
- T2DM treated with diet and exercise alone or with up to 2 oral anti-diabetic drugs.
Show all 10Show fewer
- Have stable glycemic control indicated by no changed treatment within 3 months prior to enrolment.
- Hemoglobin A1c less than 10.5% at screening (HbA1c value according to international Diabetes Control and Complications Trial standard).
- Fasting plasma glucose ≤ 11.0 mmol/L at screening.
- Provision of signed, written and dated informed consent for optional genetic/biomarker research.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the before Day -1
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results at screening and check-in, as judged by the PI.
- The following strict criteria will apply at the time of screening and on Day -1:
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2 times the upper limit of the normal laboratory range
- Hemoglobin < 11 g/dL and/or neutrophils < 1500/mm3 and/or platelets < 100 000/mm3
Show all 28Show fewer
- Creatinine > 1.2 x upper limit of normal (ULN)
- Uncontrolled or inadequately controlled hypertension at the time of screening and/or on Day -1 with a resting systolic or diastolic BP > 150 mmHg or > 95 mmHg, respectively. Patients with heart rate < 50 bpm at screening and on Day -1 will be excluded.
- Any clinically significant abnormalities on 12-lead ECG at screening as judged by the PI.
- Any patient with QT interval corrected for heart rate using Fridericia's formula (QTcF) > 450 ms at screening should be excluded.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), anti-hepatitis B core (HBc) antibody, hepatitis C antibody and human immunodeficiency virus (HIV) antibody.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of Day -1 of this study. The period of exclusion begins 3 months after the final dose from a previous study or 1 month after the last visit, whichever is longer. 9. Plasma donation within 1 month of screening or any blood donation/loss more than 400 mL during the 3 months prior to screening.
- 10. Current smokers or those who have smoked or used nicotine products within the previous 1 year cotinine below the cut-off of the local laboratory).
- 11. Positive screen for drugs of abuse, cotinine or alcohol at screening or admission to the study center.
- 12. Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
- 13. Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/ acetaminophen), herbal remedies, mega-dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to admission or longer if the medication has a long half-life.
- Patients with T2DM can be on 1 to 2 anti-diabetic medications but need the medication to be on stable doses for at least 3 months. Patients with T2DM can also be on medications for comorbidities such as hypertension, dyslipidemia, hyperuricemia, thyroid disorders, benign prostate hyperplasia etc. (e.g. diuretics, statins, allopurinol, thyroxin) but need to be on a stable dose for at least 3 months.
- 14. Involvement of any AstraZeneca or study site employee or their close relatives.
- 15. Judgment by the PI that the patient should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
- 16. Vulnerable patients, e.g., kept in detention, protected adults under guardianship, trusteeship or committed to an institution by governmental or juridical order.
- 17. Reports a significant history of allergy to soaps, lotions, emollients, ointments, creams, cosmetics, adhesives or latex.
- 18. Reports a history of significant skin conditions or disorders, for example, psoriasis, atopic dermatitis, etc.
- 19. Reports a history of significant dermatologic cancers, for example, melanoma or squamous cell carcinoma. Basal cell carcinomas that were superficial or successfully removed or treated, and do not involve the investigative site are acceptable.
- 20. Presence of forearm tattoo(s). 21. History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
- 22. History of myocardial infarction, stroke, or heart failure requiring hospitalization within 6 months prior to the time of screening, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require LASER treatment within the study period.
- 23. Uncontrolled cardiovascular, hepatic, neurological or endocrine disease. 24. Use of insulin, glitazones, warfarin and amiodarone within 3 months before enrolment and use of potent CYP450 inhibitors, e.g., ketoconazole and macrolide antibiotics within 14 days before screening.
- 25. Use of anabolic steroids and systemic treatment with glucocorticoids within 3 months before screening.
- 26. Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the PI 27. Patients who cannot communicate reliably with the PI. In addition, any of the following is regarded as a criterion for exclusion from the genetic research: 28. Previous bone marrow transplant 29. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single-Blind, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacodynamics Of AZD8601 After Single Dose Administration to Male Patients With Type II Diabetes Mellitus (T2DM)
This study will be a phase I, first time in human (FiH), randomized, single-blind, placebo-controlled, SAD study in male patients with T2DM, performed at a single study center. The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65 years will be included
Read the detailed description
Part A will assess the safety and tolerability of SAD of intradermal (ID) injection of AZD8601 (modified VEGF-A RNA) and Part B will evaluate the pharmacodynamic effects of ID injection of AZD8601 in forearm skin. AZD8601 is a VEGF-A modified RNA under development as a novel modality for local production of human VEGF-A protein and is developed for the treatment of diabetic patients with ulcers. Each patient in Part A will be involved in the study for 7 to 8 weeks. Each patient in Part B will be involved in the study for 5 to 6 weeks.
Safety and tolerability variables includes Adverse events (AEs), Vital signs (BP, pulse), ECG, Hematology, Clinical chemistry, Urinalysis.
The study will include patients with T2DM that are on stable doses of 1 to 2 anti-diabetic medications. The T2DM patients may also be on medications for comorbidities such as hypertension, dyslipidemia, hyperuricemia, thyroid disorders, benign prostate hyperplasia etc. (e.g. diuretics, statins, allopurinol, thyroxin), but must be healthy otherwise.
- Being tested
- AZD8601+Placebo (SAD), AZD8601+Placebo, Placebo+Placebo
- Keywords
- Safety, Tolerability, AZD8601, Type II Diabetes
- 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.
AZD8601+Placebo (SAD)Drug
Six subjects are randomized to receive one treatment of AZD8601 and one treatment of Placebo.
Single ascending dose (SAD) with a sequential cohort design and three dose levels of AZD8601 are planned to be investigated. Subjects will receive 0.004 mg per injection of AZD8601/placebo with a total proposed dose of 0.024 mg.
AZD8601+PlaceboDrug
Subjects will receive dose with sufficient vascular endothelial growth factor (VEGF)-A protein production and a good safety profile as determined in Part A and the total dose per patient will not exceed the maximum dose given in Part A.
Placebo+PlaceboDrug
Subjects are randomized to receive 2 placebo treatments.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Three cohorts with 9 subjects and each cohort received 2 treatments (AZD8601+Placebo/ Placebo+Placebo) Receives: Drug: AZD8601+Placebo (SAD); Drug: Placebo+Placebo |
| Part B | Experimental | Subjects received 2 treatments (AZD8601+Placebo) Receives: Drug: AZD8601+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of AZD8601 by assessing summary of adverse events (Part A)
To evaluate the safety by assessing the adverse event after administration of a single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: From screening (Day -28) up to Day 29
Safety of AZD8601 by assessing number of subjects with clinically significant blood pressure (Part A)
To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: Day 1 to Day 8
Safety of AZD8601 by assessing number of subjects with Clinically significant pulse (Part A)
To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: Day 1 to Day 8
Safety of AZD8601 by assessing number of subjects with Clinically significant 12-lead electrocardiograms (ECGs) (Part A)
To evaluate the safety by assessing the number of subjects with clinically significant ECGs after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: Day 1 to Day 8
Safety of AZD8601 by assessing number of subjects with clinically significant hematology parameters (Part A)
To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: Day 1 to Day 8
Safety of AZD8601 by assessing number of subjects with clinically significant clinical chemistry laboratory results (Part A)
To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: Day 1 to Day 8
Safety of AZD8601 by assessing number of subjects with clinically significant urinalysis (Part A)
To evaluate the safety by assessing the number of subjects with clinically significant urinalysis after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Measured: Part A: Day 1 to Day 8
Safety of AZD8601 by assessing summary of adverse events (Part B)
To evaluate the safety by assessing the adverse event after administration of a single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: From screening up to Day 15
Safety of AZD8601 by assessing number of subjects with clinically significant blood pressure (Part B)
To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: Day 1 to Day 2
Safety of AZD8601 by assessing number of subjects with Clinically significant pulse (Part B)
To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: Day 1 to Day 2
Safety of AZD8601 by assessing number of subjects with Clinically significant 12-lead electrocardiograms (ECGs) (Part B)
To evaluate the safety by assessing the number of subjects with clinically significant ECGs after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: Day 1 to Day 2
Safety of AZD8601 by assessing number of subjects with clinically significant hematology parameters (Part B)
To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: Day 1 to Day 2
Safety of AZD8601 by assessing number of subjects with clinically significant clinical chemistry laboratory results (Part B)
To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: Day 1 to Day 2
Safety of AZD8601 by assessing number of subjects with clinically significant urinalysis (Part B)
To evaluate the safety by assessing the number of subjects with clinically significant urinalysis after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Measured: Part B: Day 1 to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start16 Dec 2016
- Primary completion4 Aug 2017
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Subjects With Type II Diabetes (T2DM)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, Spandauer Damm 130, 14050, Berlin, Germany
- Responsible party
- Sponsor
- Investigators
- Rainard Fuhr, Dr. med., Principal investigator, Early Phase Clinical Unit, PAREXEL International GmbH, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935712
- Sponsor's protocol ID
- D9150C00001
- Other IDs
- 2016-002316-40, 2016
- Status last verified
- Jan 2020
- First submitted
- 18 Aug 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-Blind, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacodynamics Of AZD8601 After Single Dose Administration to Male Patients With Type II Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT02935712
- Acronym / sponsor ID
- D9150C00001
- Keywords
- Safety, Tolerability, AZD8601, Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel, Spandauer Damm 130, 14050, Berlin, Germany
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 17 Oct 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 study will be a phase I, first time in human (FiH), randomized, single-blind, placebo-controlled, SAD study in male patients with T2DM, performed at a single study center. The study will consist of 2 parts, (A and B) up to 60 male patients with T2DM aged 18 to 65 years will be included
Detailed description
Part A will assess the safety and tolerability of SAD of intradermal (ID) injection of AZD8601 (modified VEGF-A RNA) and Part B will evaluate the pharmacodynamic effects of ID injection of AZD8601 in forearm skin. AZD8601 is a VEGF-A modified RNA under development as a novel modality for local production of human VEGF-A protein and is developed for the treatment of diabetic patients with ulcers. Each patient in Part A will be involved in the study for 7 to 8 weeks. Each patient in Part B will be involved in the study for 5 to 6 weeks.
Safety and tolerability variables includes Adverse events (AEs), Vital signs (BP, pulse), ECG, Hematology, Clinical chemistry, Urinalysis.
The study will include patients with T2DM that are on stable doses of 1 to 2 anti-diabetic medications. The T2DM patients may also be on medications for comorbidities such as hypertension, dyslipidemia, hyperuricemia, thyroid disorders, benign prostate hyperplasia etc. (e.g. diuretics, statins, allopurinol, thyroxin), but must be healthy otherwise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: AZD8601+Placebo (SAD), Drug: Placebo+PlaceboThree cohorts with 9 subjects and each cohort received 2 treatments (AZD8601+Placebo/ Placebo+Placebo) |
| Part B | Experimental | Drug: AZD8601+PlaceboSubjects received 2 treatments (AZD8601+Placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Male patients with mild T2DM aged 18 to 65 years with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 20 and 35 kg/m2 inclusive and weigh at least 50 kg.
- Able to understand, read and speak the German language.
- T2DM diagnosis for at least 1 year at the time of the screening visit.
Key exclusion criteria (28 listed)
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the before Day -1
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results at screening and check-in, as judged by the PI.
- Uncontrolled or inadequately controlled hypertension at the time of screening and/or on Day -1 with a resting systolic or diastolic BP > 150 mmHg or > 95 mmHg, respectively. Patients with heart rate < 50 bpm at screening and on Day -1 will be excluded.
- Any clinically significant abnormalities on 12-lead ECG at screening as judged by the PI.
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 |
|---|---|---|
| AZD8601+Placebo (SAD)Six subjects are randomized to receive one treatment of AZD8601 and one treatment of Placebo. Single ascending dose (SAD) with a sequential cohort design and three dose levels of AZD8601 are planned to be investigated. Subjects will receive 0.004 mg per injection of AZD8601/placebo with a total proposed dose of 0.024 mg. | Drug | Part A |
| AZD8601+PlaceboSubjects will receive dose with sufficient vascular endothelial growth factor (VEGF)-A protein production and a good safety profile as determined in Part A and the total dose per patient will not exceed the maximum dose given in Part A. | Drug | Part B |
| Placebo+PlaceboSubjects are randomized to receive 2 placebo treatments. | Drug | Part A |
Primary outcome
Safety of AZD8601 by assessing summary of adverse events (Part A)
Time frame: Part A: From screening (Day -28) up to Day 29
To evaluate the safety by assessing the adverse event after administration of a single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing number of subjects with clinically significant blood pressure (Part A)
Time frame: Part A: Day 1 to Day 8
To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing number of subjects with Clinically significant pulse (Part A)
Time frame: Part A: Day 1 to Day 8
To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing number of subjects with Clinically significant 12-lead electrocardiograms (ECGs) (Part A)
Time frame: Part A: Day 1 to Day 8
To evaluate the safety by assessing the number of subjects with clinically significant ECGs after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing number of subjects with clinically significant hematology parameters (Part A)
Time frame: Part A: Day 1 to Day 8
To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing number of subjects with clinically significant clinical chemistry laboratory results (Part A)
Time frame: Part A: Day 1 to Day 8
To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing number of subjects with clinically significant urinalysis (Part A)
Time frame: Part A: Day 1 to Day 8
To evaluate the safety by assessing the number of subjects with clinically significant urinalysis after administration of single dose of AZD8601 to male subjects with T2DM (Part A).
Safety of AZD8601 by assessing summary of adverse events (Part B)
Time frame: Part B: From screening up to Day 15
To evaluate the safety by assessing the adverse event after administration of a single dose of AZD8601 to male subjects with T2DM (Part B).
Safety of AZD8601 by assessing number of subjects with clinically significant blood pressure (Part B)
Time frame: Part B: Day 1 to Day 2
To evaluate the safety by assessing the number of subjects with clinically significant blood pressure after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Safety of AZD8601 by assessing number of subjects with Clinically significant pulse (Part B)
Time frame: Part B: Day 1 to Day 2
To evaluate the safety by assessing the number of subjects with clinically significant pulse after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Safety of AZD8601 by assessing number of subjects with Clinically significant 12-lead electrocardiograms (ECGs) (Part B)
Time frame: Part B: Day 1 to Day 2
To evaluate the safety by assessing the number of subjects with clinically significant ECGs after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Safety of AZD8601 by assessing number of subjects with clinically significant hematology parameters (Part B)
Time frame: Part B: Day 1 to Day 2
To evaluate the safety by assessing the number of subjects with clinically significant hematology parameters after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Safety of AZD8601 by assessing number of subjects with clinically significant clinical chemistry laboratory results (Part B)
Time frame: Part B: Day 1 to Day 2
To evaluate the safety by assessing the number of subjects with clinically significant clinical chemistry laboratory results after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
Safety of AZD8601 by assessing number of subjects with clinically significant urinalysis (Part B)
Time frame: Part B: Day 1 to Day 2
To evaluate the safety by assessing the number of subjects with clinically significant urinalysis after administration of single dose of AZD8601 to male subjects with T2DM (Part B).
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 18 Jan 2020.
Related trials for Male Subjects With Type II Diabetes (T2DM)
Not yet recruitingPhase 4
Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
T2DM (Type 2 Diabetes Mellitus), CKD - Chronic Kidney Disease
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.
Rainard Fuhr, Dr. med. principal investigator
Early Phase Clinical Unit, PAREXEL International GmbH, Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Male Subjects With Type II Diabetes (T2DM), run by AstraZeneca at 1 site in Germany.
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 10 inclusion and 28 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 18 Jan 2020. 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 Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of AZD8601 by assessing summary of adverse events (Part A) (time frame: Part A: From screening (Day -28) up to Day 29). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.