DiabetesNCT05099198
Replication of the GRADE Diabetes Trial in Healthcare Claims Data
An observational study of Diabetes, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Sitagliptin and Glimepiride
- How many people
- 6,403 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 1 Aug 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes who have previously been treated with metformin.
Who may be able to join
- Age greater or equal than 30: days [0,0]
- Diagnosis of Type 2 Diabetes: days [- All Data, 0]
- 2+ recorded HbA1c levels: days [-365,0]
- Metformin use: days [-30, 0]
Who cannot join
- Type 1 or Secondary DM: days [-All Data, 0]
- Previous organ transplant: days [-All Data, 0]
- HIV/AIDS: days [-All Data, 0]
- History of bariatric surgery: days [-All Data, 0]
- Congestive heart failure: days [-All Data, 0]
- NYHA >=3: days [-All Data, 0]
Show all 24Show fewer
- Pancreatitis: days [-All Data, 0]
- Medullary thyroid cancer/MEN-2: days [-All Data, 0]
- History of MI: days [-365, 0]
- Stroke: days [-365, 0]
- Coronary Revascularization: days [-365, 0]
- PTCA/Stenting/CABG: days [-365, 0]
- Trans myocardial revascularization: days [-365, 0]
- Carotid bypass: days [-365, 0]
- Cerebrovascular revascularization: days [-365, 0]
- PVD: days [-365, 0]
- CCI >=10: days [-365, 0]
- History of cancer, other than non-melanoma skin cancer: days [-1,825, 0]
- Treatment of metformin more than 10 years: days [-3,650, 0]
- Treatment with any diabetes drug other than metformin; PCOS; symptomatic hyperglycemia; pregnancy; gestational diabetes: days [-180, 0]
- History of hemolytic anemia; history of severe liver disease; current alcoholism; chronic transfusion requirement; ESRD: days [-180, 0]
- Oral, IV, or IM cortisone, hydrocortisone, prednisone, methylprednisone, or dexamethasone: days [-90, 0]
- Treatment with atypical antipsychotics, language barriers, nursing home, or missing age or gender: days {-180, 0]
- Hospitalization with length of stay >3 days: days [-30, 0]
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- Diabetes
- Being tested
- Sitagliptin, Glimepiride
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Sitagliptin dispensing claim is used as the reference
GlimepirideDrug
Glimepiride dispensing claim is used as the reference
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Reference group Receives: Drug: Sitagliptin | |
| Glimepiride | Exposure group Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until failure to maintain metabolic control
Lab based algorithm: time until failure to maintain metabolic control (HbA1c level >= 7.0% or 53 mmol/mol)
Measured: Through censoring or study completion, up to 765 days after cohort entry
Secondary outcomes (2)
Time until a severe hypoglycemic episode
Claims based algorithm: time until a severe hypoglycemic episode
Measured: Through censoring or study completion, up to 765 day after cohort entry
HbA1C change from baseline
Lab based algorithm: HbA1C change from baseline
Measured: Through censoring or study completion, up to 765 days after cohort entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Sep 2018
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- 6,403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099198
- Sponsor's protocol ID
- 2018P002966-DUP-GRADE
- Status last verified
- Jul 2023
- First submitted
- 25 Jun 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the GRADE Diabetes Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT05099198
- Acronym / sponsor ID
- 2018P002966-DUP-GRADE
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,403 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 29 Oct 2021 (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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | – | Drug: SitagliptinReference group |
| Glimepiride | – | Drug: GlimepirideExposure group |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes who have previously been treated with metformin.
Key inclusion criteria (4 listed)
- Age greater or equal than 30: days [0,0]
- Diagnosis of Type 2 Diabetes: days [- All Data, 0]
- 2+ recorded HbA1c levels: days [-365,0]
- Metformin use: days [-30, 0]
Key exclusion criteria (24 listed)
- Type 1 or Secondary DM: days [-All Data, 0]
- Previous organ transplant: days [-All Data, 0]
- HIV/AIDS: days [-All Data, 0]
- History of bariatric surgery: days [-All Data, 0]
- Congestive heart failure: days [-All Data, 0]
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 |
|---|---|---|
| SitagliptinSitagliptin dispensing claim is used as the reference | Drug | Sitagliptin |
| GlimepirideGlimepiride dispensing claim is used as the reference | Drug | Glimepiride |
Primary outcome
Time until failure to maintain metabolic control
Time frame: Through censoring or study completion, up to 765 days after cohort entry
Lab based algorithm: time until failure to maintain metabolic control (HbA1c level >= 7.0% or 53 mmol/mol)
2 secondary outcomes
Time until a severe hypoglycemic episode
Time frame: Through censoring or study completion, up to 765 day after cohort entry
HbA1C change from baseline
Time frame: Through censoring or study completion, up to 765 days after cohort entry
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 27 Jul 2023.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
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 Diabetes, run by Brigham and Women's Hospital at 1 site 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 24 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 27 Jul 2023. 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 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. 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?
Time until failure to maintain metabolic control (time frame: Through censoring or study completion, up to 765 days after cohort entry). 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 27 Jul 2023.