Type 2 DiabetesNCT06236672
Impact of GLP-1 RAs Compared to Basal Insulin Start in Patients Living With Type 2 Diabetes and Chronic Kidney Disease
An observational study of Type 2 Diabetes and Chronic Kidney Diseases, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial summary
The overall objective of this study is to compare the effectiveness of adding a glucagon-like peptide-1 receptor agonist compared with adding basal insulin for patients with type 2 diabetes and chronic kidney disease, already treated with an sodium-glucose cotransporter-2 inhibitor and not currently reaching target… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Diseases
- What is being tested?
- GLP-1 receptor agonist and basal insulin
- How many people
- 348 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2023to 29 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with T2D and CKD with a background antihyperglycemic treatment of an SGLT2i
Who may be able to join
- 18 years or older as of the index date
- Clinical diagnosis of T2D ≥ one year
- Diagnosis of CKD (defined by Diabetes Canada guideline) with eGFR 15-59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 with the uACR ≥ 2mmol/L
- Use of any SGLT2i for more than 6 months
- Baseline HbA1c ≥7.5%
Who cannot join
- Clinical diagnosis of type 1 diabetes (T1D)
- Most recent eGFR ≤ 15 ml/min/1.73 m2
- Documented history or family history of Medullary Thyroid Carcinoma or Multiple Endocrine Neoplasia type 2
- Hypersensitivity to GLP-1 RA or any product component
- Initiation of a second AHA therapy on the index date together with GLP-1RA
- Previous use of any GLP-1 RA therapy
- Previous use of basal and bolus insulin therapy
- Participation in a research study with an Investigational Product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Compared to Basal Insulin Start on Metabolic Targets in Patients Living With Type 2 Diabetes and Chronic Kidney Disease (Impact GLP-1 CKD)
The overall objective of this study is to compare the effectiveness of adding a glucagon-like peptide-1 receptor agonist compared with adding basal insulin for patients with type 2 diabetes and chronic kidney disease, already treated with an sodium-glucose cotransporter-2 inhibitor and not currently reaching target glycemic control. All sociodemographic information and clinical variables will be retrieved from the LMC Diabetes Registry.
Read the detailed description
This study is a retrospective, non-inferiority cohort study using demographic and clinical data from the LMC Diabetes Registry. The study population will be adult patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) with a background antihyperglycemic treatment (AHA) of a sodium-glucose cotransporter-2 inhibitor (SGLT2i) at LMC Diabetes \& Endocrinology. Two cohorts will be assessed for eligibility: patients who initiated a glucagon-like peptide-1 receptor agonist (GLP-1 RA), and patients who initiated a basal insulin, between January 2019 and December 2022. Only patients who have given consent for their medical records to be used for research purposes will be included. The date that the GLP-1 RA or the basal insulin was initiated will be considered the index date as well as the baseline date.
The LMC Diabetes Registry will be queried to retrieve information for the sociodemographic information and clinical outcomes. Baseline characteristics such as HbA1c, blood pressure, eGFR, uACR, ALT, low-density lipoprotein (LDL), high-density lipoprotein (HDL), cholesterol, triglycerides, body weight, and BMI at the time of GLP-1 RA or basal insulin initiation will be recorded. Subsequent changes in these variables, self-reported hypoglycemic events, proportion of patients with HbA1c ≤ 6.5% and ≤ 7.0%, proportion of patients who discontinued GLP-1 RA or basal insulin will be recorded at the last available follow-up visit at 26-52 weeks following the index date.
Patients initiating a GLP-1 RA will be matched 1:1 to patients initiating a basal insulin by means of propensity score matching. The propensity score (odds of participants' treatment being GLP- 1 RA) will be estimated with a logistic regression model, with GLP-1 RA use as the outcome variable and the following variables to be potentially used as covariates: age, gender, ethnicity, education, duration of T2D (years), BMI, systolic blood pressure, HbA1c at baseline, fasting plasma lipids (LDL, HDL), AHA (dual, triple, quadruple, add on to insulin), comorbidities (macrovascular complications, microvascular complications, hypertension, dyslipidemia, smoking status,), anti-hypertensive therapy, and lipid lowering therapy.
The primary objective of the study is to compare the change in HbA1c from baseline to follow-up (26-to-52 weeks) between the GLP-1 RA initiation group and the basal insulin initiation group in patients diagnosed T2D and CKD, treated with an SGLT2i. Only patients who provide a primary endpoint value at 26-52 weeks on-treatment will be included in the primary endpoint evaluation.
- Conditions
- Type 2 Diabetes, Chronic Kidney Diseases
- Being tested
- GLP-1 receptor agonist, basal insulin
- Keywords
- type 2 diabetes, chronic kidney disease, GLP-1 RA, basal insulin, antihyperglycemic medication
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
GLP-1 RA initiated between January 2019 and December 2022
basal insulinDrug
basal insulin initiated between January 2019 and December 2022
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 RA group | adult patients with T2D and CKD who initiated GLP-1 RA therapy Receives: Drug: GLP-1 receptor agonist | |
| basal insulin group | adult patients with T2D and CKD who initiated basal insulin therapy Receives: Drug: basal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in HbA1c (%)
To compare change in HbA1c from baseline to follow-up between the GLP-1 RA initiation group and the basal insulin initiation group
Measured: baseline to 26-to-52 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start15 Feb 2023
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
- Investigators
- Alexander Abitbol, MD, Principal investigator, LMC Diabetes & Endocrinology Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236672
- Sponsor's protocol ID
- Impact GLP-1 CKD
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu L, Bradley RM, Auerbach P, Abitbol A. Real-world impact of adding a glucagon-like peptide-1 receptor agonist compared with basal insulin on metabolic targets in adults living with type 2 diabetes and chronic kidney disease already treated with a sodium-glucose co-transporter-2 inhibitor: The Impact GLP-1 CKD study. Diabetes Obes Metab. 2024 Oct;26(10):4674-4683. doi: 10.1111/dom.15834. Epub 2024 Aug 7.
PubMed 39113258
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Compared to Basal Insulin Start on Metabolic Targets in Patients Living With Type 2 Diabetes and Chronic Kidney Disease (Impact GLP-1 CKD)
- ClinicalTrials.gov ID
- NCT06236672
- Acronym / sponsor ID
- Impact GLP-1 CKD
- Conditions
- Type 2 Diabetes, Chronic Kidney Diseases
- Keywords
- type 2 diabetes, chronic kidney disease, GLP-1 RA, basal insulin, antihyperglycemic medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 1 Feb 2024 (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 overall objective of this study is to compare the effectiveness of adding a glucagon-like peptide-1 receptor agonist compared with adding basal insulin for patients with type 2 diabetes and chronic kidney disease, already treated with an sodium-glucose cotransporter-2 inhibitor and not currently reaching target glycemic control. All sociodemographic information and clinical variables will be retrieved from the LMC Diabetes Registry.
Detailed description
This study is a retrospective, non-inferiority cohort study using demographic and clinical data from the LMC Diabetes Registry. The study population will be adult patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) with a background antihyperglycemic treatment (AHA) of a sodium-glucose cotransporter-2 inhibitor (SGLT2i) at LMC Diabetes \& Endocrinology. Two cohorts will be assessed for eligibility: patients who initiated a glucagon-like peptide-1 receptor agonist (GLP-1 RA), and patients who initiated a basal insulin, between January 2019 and December 2022. Only patients who have given consent for their medical records to be used for research purposes will be included. The date that the GLP-1 RA or the basal insulin was initiated will be considered the index date as well as the baseline date.
The LMC Diabetes Registry will be queried to retrieve information for the sociodemographic information and clinical outcomes. Baseline characteristics such as HbA1c, blood pressure, eGFR, uACR, ALT, low-density lipoprotein (LDL), high-density lipoprotein (HDL), cholesterol, triglycerides, body weight, and BMI at the time of GLP-1 RA or basal insulin initiation will be recorded. Subsequent changes in these variables, self-reported hypoglycemic events, proportion of patients with HbA1c ≤ 6.5% and ≤ 7.0%, proportion of patients who discontinued GLP-1 RA or basal insulin will be recorded at the last available follow-up visit at 26-52 weeks following the index date.
Patients initiating a GLP-1 RA will be matched 1:1 to patients initiating a basal insulin by means of propensity score matching. The propensity score (odds of participants' treatment being GLP- 1 RA) will be estimated with a logistic regression model, with GLP-1 RA use as the outcome variable and the following variables to be potentially used as covariates: age, gender, ethnicity, education, duration of T2D (years), BMI, systolic blood pressure, HbA1c at baseline, fasting plasma lipids (LDL, HDL), AHA (dual, triple, quadruple, add on to insulin), comorbidities (macrovascular complications, microvascular complications, hypertension, dyslipidemia, smoking status,), anti-hypertensive therapy, and lipid lowering therapy.
The primary objective of the study is to compare the change in HbA1c from baseline to follow-up (26-to-52 weeks) between the GLP-1 RA initiation group and the basal insulin initiation group in patients diagnosed T2D and CKD, treated with an SGLT2i. Only patients who provide a primary endpoint value at 26-52 weeks on-treatment will be included in the primary endpoint evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RA group | – | Drug: GLP-1 receptor agonistadult patients with T2D and CKD who initiated GLP-1 RA therapy |
| basal insulin group | – | Drug: basal insulinadult patients with T2D and CKD who initiated basal insulin therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with T2D and CKD with a background antihyperglycemic treatment of an SGLT2i
Key inclusion criteria (5 listed)
- 18 years or older as of the index date
- Clinical diagnosis of T2D ≥ one year
- Diagnosis of CKD (defined by Diabetes Canada guideline) with eGFR 15-59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 with the uACR ≥ 2mmol/L
- Use of any SGLT2i for more than 6 months
- Baseline HbA1c ≥7.5%
Key exclusion criteria (8 listed)
- Clinical diagnosis of type 1 diabetes (T1D)
- Most recent eGFR ≤ 15 ml/min/1.73 m2
- Documented history or family history of Medullary Thyroid Carcinoma or Multiple Endocrine Neoplasia type 2
- Hypersensitivity to GLP-1 RA or any product component
- Initiation of a second AHA therapy on the index date together with GLP-1RA
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 agonistGLP-1 RA initiated between January 2019 and December 2022 | Drug | GLP-1 RA group |
| basal insulinbasal insulin initiated between January 2019 and December 2022 | Drug | basal insulin group |
Primary outcome
change in HbA1c (%)
Time frame: baseline to 26-to-52 weeks follow-up
To compare change in HbA1c from baseline to follow-up between the GLP-1 RA initiation group and the basal insulin initiation group
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 1 Feb 2024.
- Derived from this study: PubMed 39113258Chu L, Bradley RM, Auerbach P, Abitbol A. Real-world impact of adding a glucagon-like peptide-1 receptor agonist compared with basal insulin on metabolic targets in adults living with type 2 diabetes and chronic kidney disease already treated with a sodium-glucose co-transporter-2 inhibitor: The Impact GLP-1 CKD study. Diabetes Obes Metab. 2024 Oct;26(10):4674-4683. doi: 10.1111/dom.15834. Epub 2024 Aug 7.
- Individual participant dataSharing planned: No
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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.
Alexander Abitbol, MD principal investigator
LMC Diabetes & Endocrinology Ltd.
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 and Chronic Kidney Diseases, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
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 8 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 1 Feb 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 Canada. 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 HbA1c (%) (time frame: baseline to 26-to-52 weeks follow-up). 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 NCT06236672, which also lists 1 linked publication.
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 1 Feb 2024.