Type 2 Diabetes MellitusHARRPNCT06099067
Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Sweden.
Trial summary
Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Canagliflozin, DPP4 inhibitor and Liraglutide
- How many people
- 239,990 participants
- Where
- 1 siteSweden
- Study dates
- 15 May 2020to 31 Aug 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI. All subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.
The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated
Please see the Criteria for each under:
- CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010
- LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049
- SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus
Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.
Read the detailed description
RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Canagliflozin, DPP4 inhibitor, Liraglutide, Saxagliptin, 2nd generation Sulfonylurea
- Keywords
- Clinical Trial, Emulation, Epidemiology, Type 2 Diabetes, Regulatory, Real World Evidence, Real World Data
- 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.
CanagliflozinDrug
Canagliflozin dispensing claim is used as the exposure drug in CANVAS replication
DPP4 inhibitorDrug
DPP4 inhibitor dispensing claim is used as the reference drug in CANVAS and LEADER replications
LiraglutideDrug
Liraglutide dispensing claim is used as the Exposure drug in LEADER replication
SaxagliptinDrug
Saxagliptin dispensing claim is used as the Exposure drug in SAVOR-TIMI replication
2nd generation SulfonylureaDrug
2nd generation Sulfonylurea dispensing claim is used as the Exposure drug in SAVOR-TIMI replication
| Study group | Role | What they receive |
|---|---|---|
| CANVAS Canagliflozin | CANVAS expousre Group Receives: Drug: Canagliflozin | |
| CANVAS DPP4i | CANVAS reference Group Receives: Drug: DPP4 inhibitor | |
| LEADER Liraglutide | LEADER exposure Group Receives: Drug: Liraglutide | |
| LEADER DPP4i | LEADER reference Group Receives: Drug: DPP4 inhibitor | |
| SAVOR-TIMI Saxagliptin | SAVOR-TIMI exposure Group Receives: Drug: Saxagliptin | |
| SAVOR-TIMI 2nd generation Sulfonylurea | SAVOR-TIMI reference Group Receives: Drug: 2nd generation Sulfonylurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-point MACE
3-point MACE: Relative hazard of composite outcome of Stroke, MI, and Mortality
Measured: Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 May 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 239,990 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099067
- Sponsor's protocol ID
- D1843R00345
- Acronym
- HARRP
- Status last verified
- Aug 2024
- First submitted
- 6 Apr 2023
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06099067
- Acronym / sponsor ID
- HARRP / D1843R00345
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Clinical Trial, Emulation, Epidemiology, Type 2 Diabetes, Regulatory, Real World Evidence, Real World Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239,990 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Oct 2023 (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.
Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.
Detailed description
RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CANVAS Canagliflozin | – | Drug: CanagliflozinCANVAS expousre Group |
| CANVAS DPP4i | – | Drug: DPP4 inhibitorCANVAS reference Group |
| LEADER Liraglutide | – | Drug: LiraglutideLEADER exposure Group |
| LEADER DPP4i | – | Drug: DPP4 inhibitorLEADER reference Group |
| SAVOR-TIMI Saxagliptin | – | Drug: SaxagliptinSAVOR-TIMI exposure Group |
| SAVOR-TIMI 2nd generation Sulfonylurea | – | Drug: 2nd generation SulfonylureaSAVOR-TIMI reference Group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI. All subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.
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 |
|---|---|---|
| CanagliflozinCanagliflozin dispensing claim is used as the exposure drug in CANVAS replication | Drug | CANVAS Canagliflozin |
| DPP4 inhibitorDPP4 inhibitor dispensing claim is used as the reference drug in CANVAS and LEADER replications | Drug | CANVAS DPP4i, LEADER DPP4i |
| LiraglutideLiraglutide dispensing claim is used as the Exposure drug in LEADER replication | Drug | LEADER Liraglutide |
| SaxagliptinSaxagliptin dispensing claim is used as the Exposure drug in SAVOR-TIMI replication | Drug | SAVOR-TIMI Saxagliptin |
| 2nd generation Sulfonylurea2nd generation Sulfonylurea dispensing claim is used as the Exposure drug in SAVOR-TIMI replication | Drug | SAVOR-TIMI 2nd generation Sulfonylurea |
Primary outcome
3-point MACE
Time frame: Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]
3-point MACE: Relative hazard of composite outcome of Stroke, MI, and Mortality
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 30 Aug 2024.
- CANVASLink provided by the sponsor.
- LEADERLink provided by the sponsor.
- SAVOR-TIMILink provided by the sponsor.
- The Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2024. 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 Sweden. 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?
3-point MACE (time frame: Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]). 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 30 Aug 2024.