Diabetes Mellitus, Type 2NCT04034524
Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin
An observational study of Diabetes Mellitus, Type 2, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin. 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?
- GLP-1 receptor agonist and Insulin
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 31 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
- Adult, Older adult
Study population: Patients with type 2 diabetes with prior and concomitant use of metformin and other oral anti diabetic agents
Who may be able to join
- Age>=18 years
- at least 180 days of continuous enrollment prior to index date
- at least 1 Type 2 diabetes diagnosis code prior to index date
- (for cohort #1) at least 2 metformin dispensings prior to index date AND days supply overlap on cohort entry date (with 14 days of grace period before)
Who cannot join
- any type 1 diabetes diagnosis code prior to index date
- medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date
- h/o pancreatitis
- h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia)
- index injectable is a combination of GLP1-RA plus insulin
- index GLP1-RA is Saxenda (indicated for weight loss) or liraglutide at 3.0mg dose
Show all 18Show fewer
- index insulin regimen includes both basal and prandial insulin, or premixed insulin
- Any prior GLP1-RA use (Applied washout for 180 days)
- Any prior insulin use; Sometimes insulin is transiently used at diagnosis (Applied washout for 180 days)
- Secondary diabetes
- Gestational diabetes
- Nursing home admission (because we don't have pharmacy claims)
- Age <18 years
- Chronic kidney disease stage 4-6
- Advanced cancer
- End stage renal disease
- For A1c cohort only:
- -HbA1c >12%
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02138
About this study
Official title: An Observational Study of Glycemic Control and Cardiovascular Outcomes Among Patients With Type 2 Diabetes Newly Initiating Glucagon-like Peptide-1 Receptor Agonists (GLP1) Versus Basal Insulin in Routine Care Settings
This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.
Read the detailed description
The 2019 ADA-EASD clinical treatment guidelines recommend a GLP-1RA over basal insulin for patients with type 2 diabetes with suboptimal glycemic control despite metformin and a second-line glucose lowering agent. The basis of this recommendation is due to the side effect profiles of these two medications (i.e. reduced risk of hypoglycemia, some weight loss with GLP-1RA), convenience (once weekly injection) and the fact that the price of insulin has skyrocketed in recent years. Prior head-to-head randomized trials (EAGLE, LEAD 5) comparing select GLP-1RA and basal insulin have found mixed results. In EAGLE, adding either insulin glargine or liraglutide to patients with poorly controlled type 2 diabetes found no differences in the primary outcome (percentage of people reaching HbA1c < 7%). In LEAD 5, liraglutide was associated with a slightly greater HbA1c reduction than glargine, however the dose of insulin was approximately 50% less than the dose used in EAGLE. The objective of this observational study is to describe the comparative effectiveness and safety of newly initiating a GLP1RA versus basal insulin in patients with type 2 diabetes using metformin and another oral glucose lowering medicine.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- GLP-1 receptor agonist, Insulin
- 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.
GLP-1 receptor agonistDrug
any GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg)
InsulinDrug
Also called Basal Insulin
glargine, detemir, neutral protamine Hagedorn (NPH), degludec
| Study group | Role | What they receive |
|---|---|---|
| New users of GLP1 receptor agonists (exposure) | Not described Receives: Drug: GLP-1 receptor agonist | |
| New users of basal insulin (reference) | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until first composite CV event (myocardial infarction, stroke)
Measured: Through Study Completion, an estimated average of 1 year
Secondary outcomes (5)
Time until first myocardial infarction
Measured: Through Study Completion, an estimated average of 1 year
Time until first stroke
Measured: Through Study Completion, an estimated average of 1 year
Time until first serious hypoglycemic event
Measured: Through Study Completion, an estimated average of 1 year
Time until first episode of acute pancreatitis
Measured: Through Study Completion, an estimated average of 1 year
Time until first episode of acute cholecystitis
Measured: Through Study Completion, an estimated average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 May 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Luo, Brigham and Women's Hospital
- Investigators
- Jessica M Franklin, PHD, Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034524
- Sponsor's protocol ID
- 2011P002580-118
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Glycemic Control and Cardiovascular Outcomes Among Patients With Type 2 Diabetes Newly Initiating Glucagon-like Peptide-1 Receptor Agonists (GLP1) Versus Basal Insulin in Routine Care Settings
- ClinicalTrials.gov ID
- NCT04034524
- Acronym / sponsor ID
- 2011P002580-118
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 26 Jul 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.
This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.
Detailed description
The 2019 ADA-EASD clinical treatment guidelines recommend a GLP-1RA over basal insulin for patients with type 2 diabetes with suboptimal glycemic control despite metformin and a second-line glucose lowering agent. The basis of this recommendation is due to the side effect profiles of these two medications (i.e. reduced risk of hypoglycemia, some weight loss with GLP-1RA), convenience (once weekly injection) and the fact that the price of insulin has skyrocketed in recent years. Prior head-to-head randomized trials (EAGLE, LEAD 5) comparing select GLP-1RA and basal insulin have found mixed results. In EAGLE, adding either insulin glargine or liraglutide to patients with poorly controlled type 2 diabetes found no differences in the primary outcome (percentage of people reaching HbA1c < 7%). In LEAD 5, liraglutide was associated with a slightly greater HbA1c reduction than glargine, however the dose of insulin was approximately 50% less than the dose used in EAGLE. The objective of this observational study is to describe the comparative effectiveness and safety of newly initiating a GLP1RA versus basal insulin in patients with type 2 diabetes using metformin and another oral glucose lowering medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New users of GLP1 receptor agonists (exposure) | – | Drug: GLP-1 receptor agonist |
| New users of basal insulin (reference) | – | Drug: Insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes with prior and concomitant use of metformin and other oral anti diabetic agents
Key inclusion criteria (4 listed)
- Age>=18 years
- at least 180 days of continuous enrollment prior to index date
- at least 1 Type 2 diabetes diagnosis code prior to index date
- (for cohort #1) at least 2 metformin dispensings prior to index date AND days supply overlap on cohort entry date (with 14 days of grace period before)
Key exclusion criteria (18 listed)
- any type 1 diabetes diagnosis code prior to index date
- medullary thyroid carcinoma, multiple endocrine neoplasia type 2 (both black box warnings) prior to index date
- h/o pancreatitis
- h/o recurrent hypoglycemia (i.e. more than 1 hospitalization / emergency department encounter in primary diagnosis position for hypoglycemia)
- index injectable is a combination of GLP1-RA plus 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 |
|---|---|---|
| GLP-1 receptor agonistany GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg) | Drug | New users of GLP1 receptor agonists (exposure) |
| InsulinAlso: Basal Insulinglargine, detemir, neutral protamine Hagedorn (NPH), degludec | Drug | New users of basal insulin (reference) |
Primary outcome
Time until first composite CV event (myocardial infarction, stroke)
Time frame: Through Study Completion, an estimated average of 1 year
5 secondary outcomes
Time until first myocardial infarction
Time frame: Through Study Completion, an estimated average of 1 year
Time until first stroke
Time frame: Through Study Completion, an estimated average of 1 year
Time until first serious hypoglycemic event
Time frame: Through Study Completion, an estimated average of 1 year
Time until first episode of acute pancreatitis
Time frame: Through Study Completion, an estimated average of 1 year
Time until first episode of acute cholecystitis
Time frame: Through Study Completion, an estimated average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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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.
Jessica M Franklin, PHD study chair
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 Mellitus, Type 2, 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 18 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: status not confirmed, as of the sponsor's last update on 9 Jul 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 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?
Results are not available in the source record.
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 first composite CV event (myocardial infarction, stroke) (time frame: Through Study Completion, an estimated average of 1 year). 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 9 Jul 2020.