Diabetes Mellitus, Type 2ARISENCT04042441
A Research Study, Looking at How Ryzodeg® (Insulin Degludec/Insulin Aspart) Works in People With Type 2 Diabetes in Local Clinical Practice
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 64 sites in 6 countries.
Trial summary
The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Insulin Degludec/Insulin Aspart
- How many people
- 1,122 participants
- Where
- 64 sitesin 6 countries
- Study dates
- 29 Jul 2019to 11 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real-world population of type 2 patients, who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice
Who may be able to join
- Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.
- The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent.
- Available and documented HbA1c value for 12 weeks or less prior to signing informed consent.
Who cannot join
- Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.
- Previous participation in this study. Participation is defined as signed informed consent.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Previous treatment with Ryzodeg®.
Trial locations and contacts
64 sites in 6 countries.
64 sites in 6 countries
Malaysia14 sites
Island Hospital
George Town, 10450
Remedic Clinic
Kangar, 01000
Pantai Hospital
Kedah, 08000
Kota Bahru Medical Centre Sdn Bhd
Kelantan, 15200
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
Gleneagles Hospital
Kuala Lumpur, 50450
Subang Jaya Medical Center
Kuala Selangor, 47500
Thomson Hospital
Kuala Selangor, 47810
Borneo Medical Centre
Kuching, 93350
KPJ Kuching
Kuching, 93350
Mahkota Medical Center
Malacca, 75000
Pantai Hospital Ayer Keroh
Malacca, 75450
Klinik Chong
Perak, 35800
Hospital Putrajaya
Putrajaya, 62250
Philippines11 sites
Panay Healthcare Medical Center
Aklan
Perpetual Succor Hospital
Cebu City
Davao Doctors Hospital
Davao City, 8000
Iloilo Diabetes Care Center
Iloilo City, 5000
Makati Medical Center
Makati City, 1229
University of Santo Tomas
Manila, 1015
Manila Doctor's Hospital
Manila
University of Sto. Tomas Hospital
Manila
St. Luke's Medical Center
Quezon City, 1102
Providence Hospital
Quezon City
University of the East-Ramon Magsaysay Memorial Medical Ctr
Quezon City
Australia10 sites
Box Hill Specialist Consulting rooms
Box Hill, Victoria, 3128
Rockingham General Hospital
Cooloongup, Western Australia, 6168
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Hobart Cardiology
Hobart, Tasmania, 7000
South Australian Endocrine Research
Keswick, South Australia, 5035
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, 3004
Mater Hospital Brisbane
South Brisbane, Queensland, 4101
Royal North Shore Hospital
St Leonards, New South Wales, 2065
Illawarra Diabetes Service Clinical Trials & Research Unit
Wollongong, New South Wales, 2500
India10 sites
Columbia Asia Hospital
Bangalore, Karnataka, 560024
Pace Diabetes Center
Bangalore, Karnataka, 560043
AMRI Hospital
Bhubaneswar, Odisha, 751030
R.M. Diabetes Education & Research Foundation
Chennai, Tamil Nadu, 600040
Max Super Speciality Shalimar Bhagh
Delhi, New Delhi, 110088
Excelcare Hospital
Guwahati, Assam, 781033
Narayana Superspeciality Hospital
Howrah, West Bengal, 711103
Fortis Heart Institute and Multispeciality Hospital
Mohali, Punjab, 160062
DEW Medicare & Trinity hospital
Nagpur, Maharashtra, 440015
Fortis Hospital
New Delhi, 110088
Saudi Arabia10 sites
King Abdulaziz University Hospital
Jeddah, 22252
Dr Bakhsh Hospital
Jeddah, 23216
Dr. Ghassan N. Faroun Hospital
Jeddah, 23521
Saudi German Hospital
Jeddah, 23521
My clinic
Jeddah
Umm Alquara University Hospital
Mecca, 24381
Specialized medical center
Riyadh, 12311
Riyadh Care Hospital
Riyadh, 14214
National Guard Hospital
Riyadh, 14611
Dallah Hospital
Riyadh, 14963
South Africa9 sites
Union Hospital
Alberton, 1449
Dr H Bacus
Berea, KwaZulu-Natal, 4091
Medi-Clinic Bloemfontein
Bloemfontein, 9301
Hemant Makan
Johannesburg, Gauteng, 1827
Dr Moosa's Rooms
Lenasia, Gauteng, 1827
Greenacres Hospital
Port Elizabeth, Eastern Cape, 6045
Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, 6045
ProHealth Wellness Centre
Port Elizabeth, Eastern Cape, 6201
Prof P. Joshi
Pretoria, Gauteng, 0181
About this study
Official title: A Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg® (Insulin Degludec/Insulin Aspart) in Patients With Type 2 Diabetes Mellitus in a Real-world Setting
The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Insulin Degludec/Insulin Aspart
- 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.
Insulin Degludec/Insulin AspartDrug
Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study.
| Study group | Role | What they receive |
|---|---|---|
| Ryzodeg® as per local practice | Real-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice. Receives: Drug: Insulin Degludec/Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Percentage point
Measured: From baseline (week 0) to end of study (week 26-36)
Secondary outcomes (18)
HbA1c less than 7% (Yes/No)
Percentage of patients
Measured: At the end of study (week 26-36)
HbA1c less than pre-defined individual treatment target (Yes/No)
Percentage of patients
Measured: At the end of study (week 26-36)
Change in local laboratory measured fasting plasma glucose (FPG)
mg/dL
Measured: From baseline (week 0) to end of study (week 26-36)
Change in local laboratory measured FPG
mmol/L
Measured: From baseline (week 0) to end of study (week 26-36)
Change in insulin dose (total, basal, prandial)
units/day
Measured: From baseline (week 0) to end of study (week 26-36)
Change in body weight
Kg
Measured: From baseline (week 0) to end of study (week 26-36)
Number of patient recollection of non-severe hypoglycaemic episodes
Number of episodes
Measured: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of non-severe hypoglycaemic episodes
Number of episodes
Measured: At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Number of episodes
Measured: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Number of episodes
Measured: At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Number of patient recollection of overall severe hypoglycaemic episodes
Number of episodes
Measured: At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of overall severe hypoglycaemic episodes
Number of episodes
Measured: At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
Number of weekly self-measured plasma glucose (SMPG) measurements
Number of measurements
Measured: At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
Number of weekly self-measured plasma glucose (SMPG) measurements
Number of measurements
Measured: At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
Reason for initiating Ryzodeg® (pre-specified response option(s))
Percentage of patients per response option
Measured: At baseline (week 0)
Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)
Percentage of patients
Measured: At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))
Percentage of patients per response option
Measured: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Time period from initiation to discontinuation of treatment with Ryzodeg®
Days
Measured: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start29 Jul 2019
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042441
- Sponsor's protocol ID
- NN5401-4525
- Other IDs
- U1111-1227-8654
- Acronym
- ARISE
- Status last verified
- Sep 2024
- First submitted
- 31 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Fulcher GR, Cohen ND, Davies K, d'Emden M, Glastras SJ, Mah PM, McCallum RW, Moses R, Thong KY, Roberts A. Initiating or switching to insulin degludec/insulin aspart in a real-world population of adults with type 2 diabetes in Australia: results from a prospective, non-interventional study. Intern Med J. 2024 Oct;54(10):1626-1633. doi: 10.1111/imj.16492. Epub 2024 Aug 22.
PubMed 39171857Baruah MP, Aneja P, Pitale S, Bhograj A, Agrawala RK, Aggarwal A, Mahadev PG, Madhavdas DC, Shah S, John M, Pathan MKA, Revanna M, Chandrappa M, Singh KP. Initiation or switch to insulin degludec/insulin aspart in adults with type 2 diabetes in India: Results from a prospective, non-interventional, real-world study. J Family Med Prim Care. 2024 Sep;13(9):3590-3597. doi: 10.4103/jfmpc.jfmpc_1401_23. Epub 2024 Sep 11.
PubMed 39464932Fulcher GR, Akhtar S, Al-Jaser SJ, Medina J, Mohamed M, Nicodemus NA Jr, Olsen AH, Singh KP, Kok A. Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries. Adv Ther. 2022 Aug;39(8):3735-3748. doi: 10.1007/s12325-022-02212-3. Epub 2022 Jun 25.
PubMed 35752730Fulcher GR, Jarlov H, Piltoft JS, Singh KP, Liu L, Mohamed M, Nicodemus NA Jr, Al-Jaser SJ, Kok A. ARISE-a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: rationale and design. Endocrine. 2021 Dec;74(3):530-537. doi: 10.1007/s12020-021-02887-8. Epub 2021 Oct 12.
PubMed 34637072
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Prospective Non-interventional Study Investigating the Clinical Effectiveness of Ryzodeg® (Insulin Degludec/Insulin Aspart) in Patients With Type 2 Diabetes Mellitus in a Real-world Setting
- ClinicalTrials.gov ID
- NCT04042441
- Acronym / sponsor ID
- ARISE / NN5401-4525
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 2 Aug 2019 (actual)
- 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.
The purpose of the study is to collect information on how Ryzodeg® works in real world patients and to see if Ryzodeg® can lower blood sugar levels. Participants will get Ryzodeg® as prescribed to them by their doctor. The study will last for about 6 to 9 months. Participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ryzodeg® as per local practice | – | Drug: Insulin Degludec/Insulin AspartReal-world population of patients with Diabetes Mellitus, Type 2 (T2DM), who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world population of type 2 patients, who have been initiated or switched to Ryzodeg® from previous antihyperglycaemic treatment according to local clinical practice
Key inclusion criteria (5 listed)
- Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol.
- The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before, and independently from, the decision to include the patient in this study.
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2DM and treated with any anti-hyperglycaemic medication(s) other than Ryzodeg® for at least 26 weeks prior to signing informed consent.
- Available and documented HbA1c value for 12 weeks or less prior to signing informed consent.
Key exclusion criteria (4 listed)
- Hypersensitivity to the active substance or to any of the excipients as specified in the Ryzodeg® local label.
- Previous participation in this study. Participation is defined as signed informed consent.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Previous treatment with Ryzodeg®.
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 |
|---|---|---|
| Insulin Degludec/Insulin AspartInsulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study. | Drug | Ryzodeg® as per local practice |
Primary outcome
Change in local laboratory measured glycosylated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to end of study (week 26-36)
Percentage point
18 secondary outcomes
HbA1c less than 7% (Yes/No)
Time frame: At the end of study (week 26-36)
HbA1c less than pre-defined individual treatment target (Yes/No)
Time frame: At the end of study (week 26-36)
Change in local laboratory measured fasting plasma glucose (FPG)
Time frame: From baseline (week 0) to end of study (week 26-36)
Change in local laboratory measured FPG
Time frame: From baseline (week 0) to end of study (week 26-36)
Change in insulin dose (total, basal, prandial)
Time frame: From baseline (week 0) to end of study (week 26-36)
Change in body weight
Time frame: From baseline (week 0) to end of study (week 26-36)
Number of patient recollection of non-severe hypoglycaemic episodes
Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of non-severe hypoglycaemic episodes
Time frame: At the end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Time frame: At baseline (week 0). Episodes occurring within 4 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of nocturnal non-severe hypoglycaemic episodes
Time frame: At end of study (week 26-36). Episodes occurring within 4 weeks prior to end of study
Number of patient recollection of overall severe hypoglycaemic episodes
Time frame: At baseline (week 0). Episodes occurring within 26 weeks prior to initiation of treatment with Ryzodeg®
Number of patient recollection of overall severe hypoglycaemic episodes
Time frame: At the end of study (week 26-36). Episodes occurring within 26 weeks prior to end of study
Number of weekly self-measured plasma glucose (SMPG) measurements
Time frame: At baseline (week 0). Measurements occurring within 7 days prior to initiation of treatment with Ryzodeg®
Number of weekly self-measured plasma glucose (SMPG) measurements
Time frame: At end of study (week 26-36). Measurements occurring within 7 days prior to end of study
Reason for initiating Ryzodeg® (pre-specified response option(s))
Time frame: At baseline (week 0)
Discontinue treatment with Ryzodeg® during the treatment period (Yes/No)
Time frame: At treatment discontinuation (week 0-36) or at end of study (week 26-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Reason for discontinuing treatment with Ryzodeg® during the treatment period, if applicable, (pre-specified response option(s))
Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
Time period from initiation to discontinuation of treatment with Ryzodeg®
Time frame: At treatment discontinuation (week 0-36). After initiation of treatment with Ryzodeg® until treatment discontinuation
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 19 Sep 2024.
- Results publication: PubMed 39171857Fulcher GR, Cohen ND, Davies K, d'Emden M, Glastras SJ, Mah PM, McCallum RW, Moses R, Thong KY, Roberts A. Initiating or switching to insulin degludec/insulin aspart in a real-world population of adults with type 2 diabetes in Australia: results from a prospective, non-interventional study. Intern Med J. 2024 Oct;54(10):1626-1633. doi: 10.1111/imj.16492. Epub 2024 Aug 22.
- Derived from this study: PubMed 39464932Baruah MP, Aneja P, Pitale S, Bhograj A, Agrawala RK, Aggarwal A, Mahadev PG, Madhavdas DC, Shah S, John M, Pathan MKA, Revanna M, Chandrappa M, Singh KP. Initiation or switch to insulin degludec/insulin aspart in adults with type 2 diabetes in India: Results from a prospective, non-interventional, real-world study. J Family Med Prim Care. 2024 Sep;13(9):3590-3597. doi: 10.4103/jfmpc.jfmpc_1401_23. Epub 2024 Sep 11.
- Derived from this study: PubMed 35752730Fulcher GR, Akhtar S, Al-Jaser SJ, Medina J, Mohamed M, Nicodemus NA Jr, Olsen AH, Singh KP, Kok A. Initiating or Switching to Insulin Degludec/Insulin Aspart in Adults with Type 2 Diabetes: A Real-World, Prospective, Non-interventional Study Across Six Countries. Adv Ther. 2022 Aug;39(8):3735-3748. doi: 10.1007/s12325-022-02212-3. Epub 2022 Jun 25.
- Derived from this study: PubMed 34637072Fulcher GR, Jarlov H, Piltoft JS, Singh KP, Liu L, Mohamed M, Nicodemus NA Jr, Al-Jaser SJ, Kok A. ARISE-a prospective, non-interventional, single-arm study assessing clinical parameters associated with the use of insulin degludec/insulin aspart in patients with type 2 diabetes in real-world settings: rationale and design. Endocrine. 2021 Dec;74(3):530-537. doi: 10.1007/s12020-021-02887-8. Epub 2021 Oct 12.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
64 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 64 sites in 6 countries.
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 5 inclusion and 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Malaysia, Philippines, Australia, India, Saudi Arabia and 1 more country. 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?
Change in local laboratory measured glycosylated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of study (week 26-36)). 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 NCT04042441, which also lists 4 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 19 Sep 2024.