Diabetes Mellitus, Type 2Phase 4Lean-DMNCT04657939
Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes
A Phase 4 study testing Liraglutide and Pioglitazone in people with Diabetes Mellitus, Type 2, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The majority of people with type 2 diabetes (T2D) are overweight, and while weight gain is a major contributor to diabetes, a minority of patients with T2D are not overweight or obese. The reasons why lean or normal body weight individuals develop T2D (lean-T2D) are not yet understood. 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?
- Liraglutide and Pioglitazone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2020to 31 Oct 2022
- Phase
- Phase 4
- 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
Who may be able to join
- Lean cohort
- Men and women>18 years of age;
- Normal body weight (18.5 ≤ BMI ≤25 kg/m2);
- T2D patients can be on treatment with oral glucose lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening;
- 6.5≤HBA1c≤10% at screening;
- Agreement to maintain prior diet and exercise habits for the duration of the study.
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- Overweight cohort
- Men and women>18 years of age;
- Increased body weight (BMI >27 kg/m2);
- T2D patients can be on treatment with oral glucose lowering therapies, and must have been on these treatments for at least 12 weeks prior to screening;
- 6.5≤HBA1c≤10% at screening;
- Agreement to maintain prior diet and exercise habits for the duration of the study.
Who cannot join
- Any type of diabetes other than T2D;
- Past history of significant CAD;
- Known HF;
- Significant renal impairment (eGFR<30ml/min/m2);
- Participation in a clinical trial of an investigational medicinal product (CTIMP) in the preceding 12 weeks;
- Known hypersensitivity to dobutamine or gadolinium or any other contra-indications to MRI;
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- Participants with obesity where their girth exceeds the scanner bore;
- History of pancreatitis;
- Any history of liver disease;
- Patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
- Prior or current use of thiazolidinediones (aka PPAR-γ agonists), fibrates, GLP-1RA or insulin;
- Patients that are pregnant (female participants only);
- Inflammatory bowel disease
- Diabetic gastroparesis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals Trust
Leeds, West Yorkshire, LS1 3EX
About this study
The majority of people with type 2 diabetes (T2D) are overweight, and while weight gain is a major contributor to diabetes, a minority of patients with T2D are not overweight or obese. The reasons why lean or normal body weight individuals develop T2D (lean-T2D) are not yet understood. T2D occurs when the body does not produce enough insulin, or becomes less sensitive to its effects. Insulin acts like a key to allow sugar into cells and if someone is overweight that key works less well. Recent research suggests that T2D in lean people should be considered a different disease from the diabetes associated with obesity and the main problem in lean-T2D patients may be a reduced capacity of insulin secretion. However, some researchers argue that many seemingly thin people carry more fat than muscle, making them trim on the outside, but fat on the inside, and they are in fact not truly lean. This implies that just like overweight diabetics, lean diabetics also have high resistance to insulin. The main aim of this research is to better understand the main driver of T2D in lean individuals, as this will determine how best to treat these individuals.
There are many different types of drugs for treating T2D. Liraglutide improves insulin secretion capacity of the pancreas. Pioglitazone reduces resistance to insulin action. The investigators will compare the actions of these diabetes drugs on the blood supply and the heart's energy levels in lean-T2D and obese-T2D patients. This will allow the investigators to determine the ideal treatment strategies for improving cardiovascular health in lean-T2D patients, and better understand the role of impaired insulin secretory capacity, insulin resistance and excess fat deposition specifically in this group.
Read the detailed description
This is a single centre, open-label, randomized, cross-over study. Participants will attend 4 visits in total over the course of approximately 40 weeks. Two cohorts of patients will be recruited: 28 lean-T2D patients and 28 obese-T2D patients.
Potential participants will be invited to the research centre for a screening/ baseline visit (Visit 1). At this visit, the participants will be given the Participant Information Sheet (PIS) to read through, and given the opportunity to ask questions. If they are interested in participating, their consent will be taken in written form. Each participant will then have a series of non-invasive tests. At this baseline visit, the following assessments will be done:
- Review of medical history and concomitant medications;
- Review of history of diabetes and complications;
- Review of inclusion/exclusion criteria;
- Collection of demographic data;
- Vital signs;
- Physical examination;
- Height and weight;
- Blood pressure;
- Urine pregnancy test in women of childbearing potential;
- Venepuncture (fasting sample): 20mls;
- Multiparametric MRI;
- EndoPAT testing;
- 6 minute walk test;
- 12-lead ECG;
- Randomization;
- Dispense study medication and issue patient diary; and
- Urine sample collection.
At this visit, participants will be randomized to receive either liraglutide or pioglitazone first. Participants that are already taking certain classes of glucose-lowering medications may be excluded from the study (see exclusion criteria for more detail). Participants will continue to take their previously prescribed medications throughout the study.
After 16 weeks of treatment (Visit 2), participants will return to the research centre and have the following assessments:
- Vital signs;
- Physical examination;
- Blood pressure;
- Weight;
- Venepuncture (fasting sample): 20mls;
- 12-lead ECG;
- Multiparametric MRI;
- EndoPAT testing;
- 6 minute walk test;
- Check current medication list and patient clinical status;
- Check study medication compliance (diary review); and
- Urine sample collection.
Participants will then have an 8 week washout period, in which they will take no study drug. After these 8 weeks, they will return to the research centre (Visit 3) and have the same assessments as listed above for Visit 2. They will start taking the second study drug for 16 weeks.
After 16 weeks, participants will attend the research centre for a final time (Visit 4) and have the same assessments as listed above for Visit 2.
Multiparametric MRI assessments will consists of 2 parts: Magnetic Resonance Spectroscopy (MRS): The relative concentration of phosphocreatine to ATP (PCr/ATP) by 31P-MRS and cardiac and hepatic triglyceride content by 1H-MRS.
Collected blood will be tested for triglycerides, alanine aminotransferase, haemoglobin, haematocrit, creatinine, estimated glomerular filtration rate, N-terminal pro-B-type natriuretic peptide, insulin, free fatty acids, adiponectin, glucose and lipid profiles, glutamic acid decarboxylase antibodies, and Zinc transporter 8 antibodies. Urine will be spot-tested for albumin/ creatinine ratio.
Previous clinical studies have found an association between diabetes and impaired function of the endothelium of blood vessels. The EndoPAT 2000 is a machine that measures endothelium function via 2 thimble-sized sensors placed on the index fingers. This is a safe and non-invasive way of testing the condition of the participant's blood vessels, and testing takes about 5 minutes.
The 6 minute walk test is an exercise test that requires patients to walk along a long flat corridor for 6 minutes to see how far they can walk at their own pace.
Liraglutide will be administered at 0.6mg once daily to start, then titrated up to 1.2mg after 2 weeks if the participant's glucose levels permit. Participants will be trained how to administer the injection themselves. Glucose assessments will be done after 2 weeks of treatment with Liraglutide. Pioglitazone is taken orally. Participants will be started on 15mg once daily; this will be titrated up to 30mg after 2 weeks then to 45mg after another 2 weeks if glucose levels permit. Glucose assessments will be done 2 weeks after starting treatment, then 4 weeks after starting treatment. Participants will be told to continue their usual schedule of glucose monitoring at home while on the study drugs (no additional monitoring at home will be necessary).
Participants will be given diaries to complete while they are on both drugs.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Liraglutide, Pioglitazone
- 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.
LiraglutideDrug
Liraglutide 0.6mg once daily by subcutaneous injection escalated to 1.2mg after 2 weeks.
PioglitazoneDrug
Pioglitazone 15mg once daily tablets taken orally escalated to 30mg after 2 weeks then escalated to 45mg after another 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide-Pioglitazone | Active comparator | Participants randomised to receive liraglutide treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with pioglitazone. Receives: Drug: Liraglutide; Drug: Pioglitazone |
| Pioglitazone-Liraglutide | Active comparator | Participants randomised to receive pioglitazone treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with liraglutide. Receives: Drug: Liraglutide; Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial perfusion after treatment
Measured changes in myocardial perfusion by Magnetic Resonance Imaging (MRI) after treatment with liraglutide and pioglitazone.
Measured: 40 weeks
Secondary outcomes (7)
Myocardial energetics (PCr/ATP ratio)
Change in myocardial energetics as measured by MRI after treatment
Measured: 40 weeks
Myocardial steatosis (myocardial triglyceride content)
Change in myocardial steatosis as measured by MRI after treatment
Measured: 40 weeks
Myocardial function
Change in myocardial function as measured by MRI after treatment
Measured: 40 weeks
Insulin resistance (HOMA-IR)
Change in HOMA-IR as determined by blood results after treatment
Measured: 40 weeks
Physical performance
Change in physical performance as measured by 6 minute walk test after treatment
Measured: 40 weeks
Hepatic steatosis (hepatic triglyceride content)
Change in hepatic steatosis as measured by MRI after treatment
Measured: 40 weeks
Peripheral endothelial function
Changes in peripheral endothelial function as measured by EndoPAT after treatment
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Diabetes Mellitus, Type 2Studies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem Levelt, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657939
- Sponsor's protocol ID
- 265208
- Other IDs
- 18/0005908, 19/WM/0365
- Acronym
- Lean-DM
- Status last verified
- Feb 2023
- First submitted
- 1 Dec 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chowdhary A, Thirunavukarasu S, Joseph T, Jex N, Kotha S, Giannoudi M, Procter H, Cash L, Akkaya S, Broadbent D, Xue H, Swoboda P, Valkovic L, Kellman P, Plein S, Rider OJ, Neubauer S, Greenwood JP, Levelt E. Liraglutide Improves Myocardial Perfusion and Energetics and Exercise Tolerance in Patients With Type 2 Diabetes. J Am Coll Cardiol. 2024 Aug 6;84(6):540-557. doi: 10.1016/j.jacc.2024.04.064.
PubMed 39084829
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Beta-cell Failure in Lean Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04657939
- Acronym / sponsor ID
- Lean-DM / 265208
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 8 Dec 2020 (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 majority of people with type 2 diabetes (T2D) are overweight, and while weight gain is a major contributor to diabetes, a minority of patients with T2D are not overweight or obese. The reasons why lean or normal body weight individuals develop T2D (lean-T2D) are not yet understood. T2D occurs when the body does not produce enough insulin, or becomes less sensitive to its effects. Insulin acts like a key to allow sugar into cells and if someone is overweight that key works less well. Recent research suggests that T2D in lean people should be considered a different disease from the diabetes associated with obesity and the main problem in lean-T2D patients may be a reduced capacity of insulin secretion. However, some researchers argue that many seemingly thin people carry more fat than muscle, making them trim on the outside, but fat on the inside, and they are in fact not truly lean. This implies that just like overweight diabetics, lean diabetics also have high resistance to insulin. The main aim of this research is to better understand the main driver of T2D in lean individuals, as this will determine how best to treat these individuals.
There are many different types of drugs for treating T2D. Liraglutide improves insulin secretion capacity of the pancreas. Pioglitazone reduces resistance to insulin action. The investigators will compare the actions of these diabetes drugs on the blood supply and the heart's energy levels in lean-T2D and obese-T2D patients. This will allow the investigators to determine the ideal treatment strategies for improving cardiovascular health in lean-T2D patients, and better understand the role of impaired insulin secretory capacity, insulin resistance and excess fat deposition specifically in this group.
Detailed description
This is a single centre, open-label, randomized, cross-over study. Participants will attend 4 visits in total over the course of approximately 40 weeks. Two cohorts of patients will be recruited: 28 lean-T2D patients and 28 obese-T2D patients.
Potential participants will be invited to the research centre for a screening/ baseline visit (Visit 1). At this visit, the participants will be given the Participant Information Sheet (PIS) to read through, and given the opportunity to ask questions. If they are interested in participating, their consent will be taken in written form. Each participant will then have a series of non-invasive tests. At this baseline visit, the following assessments will be done:
- Review of medical history and concomitant medications;
- Review of history of diabetes and complications;
- Review of inclusion/exclusion criteria;
- Collection of demographic data;
- Vital signs;
- Physical examination;
- Height and weight;
- Blood pressure;
- Urine pregnancy test in women of childbearing potential;
- Venepuncture (fasting sample): 20mls;
- Multiparametric MRI;
- EndoPAT testing;
- 6 minute walk test;
- 12-lead ECG;
- Randomization;
- Dispense study medication and issue patient diary; and
- Urine sample collection.
At this visit, participants will be randomized to receive either liraglutide or pioglitazone first. Participants that are already taking certain classes of glucose-lowering medications may be excluded from the study (see exclusion criteria for more detail). Participants will continue to take their previously prescribed medications throughout the study.
After 16 weeks of treatment (Visit 2), participants will return to the research centre and have the following assessments:
- Vital signs;
- Physical examination;
- Blood pressure;
- Weight;
- Venepuncture (fasting sample): 20mls;
- 12-lead ECG;
- Multiparametric MRI;
- EndoPAT testing;
- 6 minute walk test;
- Check current medication list and patient clinical status;
- Check study medication compliance (diary review); and
- Urine sample collection.
Participants will then have an 8 week washout period, in which they will take no study drug. After these 8 weeks, they will return to the research centre (Visit 3) and have the same assessments as listed above for Visit 2. They will start taking the second study drug for 16 weeks.
After 16 weeks, participants will attend the research centre for a final time (Visit 4) and have the same assessments as listed above for Visit 2.
Multiparametric MRI assessments will consists of 2 parts: Magnetic Resonance Spectroscopy (MRS): The relative concentration of phosphocreatine to ATP (PCr/ATP) by 31P-MRS and cardiac and hepatic triglyceride content by 1H-MRS.
Collected blood will be tested for triglycerides, alanine aminotransferase, haemoglobin, haematocrit, creatinine, estimated glomerular filtration rate, N-terminal pro-B-type natriuretic peptide, insulin, free fatty acids, adiponectin, glucose and lipid profiles, glutamic acid decarboxylase antibodies, and Zinc transporter 8 antibodies. Urine will be spot-tested for albumin/ creatinine ratio.
Previous clinical studies have found an association between diabetes and impaired function of the endothelium of blood vessels. The EndoPAT 2000 is a machine that measures endothelium function via 2 thimble-sized sensors placed on the index fingers. This is a safe and non-invasive way of testing the condition of the participant's blood vessels, and testing takes about 5 minutes.
The 6 minute walk test is an exercise test that requires patients to walk along a long flat corridor for 6 minutes to see how far they can walk at their own pace.
Liraglutide will be administered at 0.6mg once daily to start, then titrated up to 1.2mg after 2 weeks if the participant's glucose levels permit. Participants will be trained how to administer the injection themselves. Glucose assessments will be done after 2 weeks of treatment with Liraglutide. Pioglitazone is taken orally. Participants will be started on 15mg once daily; this will be titrated up to 30mg after 2 weeks then to 45mg after another 2 weeks if glucose levels permit. Glucose assessments will be done 2 weeks after starting treatment, then 4 weeks after starting treatment. Participants will be told to continue their usual schedule of glucose monitoring at home while on the study drugs (no additional monitoring at home will be necessary).
Participants will be given diaries to complete while they are on both drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liraglutide-Pioglitazone | Active comparator | Drug: Liraglutide, Drug: PioglitazoneParticipants randomised to receive liraglutide treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with pioglitazone. |
| Pioglitazone-Liraglutide | Active comparator | Drug: Liraglutide, Drug: PioglitazoneParticipants randomised to receive pioglitazone treatment for 16 weeks, followed by an 8 week washout then commencing 16 weeks of treatment with liraglutide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Lean cohort
- Men and women>18 years of age;
- Normal body weight (18.5 ≤ BMI ≤25 kg/m2);
- T2D patients can be on treatment with oral glucose lowering therapies, and if they are, they must have been on these treatments for at least 12 weeks prior to screening;
- 6.5≤HBA1c≤10% at screening;
Key exclusion criteria (14 listed)
- Any type of diabetes other than T2D;
- Past history of significant CAD;
- Known HF;
- Significant renal impairment (eGFR<30ml/min/m2);
- Participation in a clinical trial of an investigational medicinal product (CTIMP) in the preceding 12 weeks;
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 |
|---|---|---|
| LiraglutideLiraglutide 0.6mg once daily by subcutaneous injection escalated to 1.2mg after 2 weeks. | Drug | Liraglutide-Pioglitazone, Pioglitazone-Liraglutide |
| PioglitazonePioglitazone 15mg once daily tablets taken orally escalated to 30mg after 2 weeks then escalated to 45mg after another 2 weeks. | Drug | Liraglutide-Pioglitazone, Pioglitazone-Liraglutide |
Primary outcome
Change in myocardial perfusion after treatment
Time frame: 40 weeks
Measured changes in myocardial perfusion by Magnetic Resonance Imaging (MRI) after treatment with liraglutide and pioglitazone.
7 secondary outcomes
Myocardial energetics (PCr/ATP ratio)
Time frame: 40 weeks
Myocardial steatosis (myocardial triglyceride content)
Time frame: 40 weeks
Myocardial function
Time frame: 40 weeks
Insulin resistance (HOMA-IR)
Time frame: 40 weeks
Physical performance
Time frame: 40 weeks
Hepatic steatosis (hepatic triglyceride content)
Time frame: 40 weeks
Peripheral endothelial function
Time frame: 40 weeks
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 Feb 2023.
- Derived from this study: PubMed 39084829Chowdhary A, Thirunavukarasu S, Joseph T, Jex N, Kotha S, Giannoudi M, Procter H, Cash L, Akkaya S, Broadbent D, Xue H, Swoboda P, Valkovic L, Kellman P, Plein S, Rider OJ, Neubauer S, Greenwood JP, Levelt E. Liraglutide Improves Myocardial Perfusion and Energetics and Exercise Tolerance in Patients With Type 2 Diabetes. J Am Coll Cardiol. 2024 Aug 6;84(6):540-557. doi: 10.1016/j.jacc.2024.04.064.
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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?
A Phase 4 study testing Liraglutide and Pioglitazone in people with Diabetes Mellitus, Type 2, run by University of Leeds at 1 site in United Kingdom.
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 12 inclusion and 14 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 Feb 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 Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 myocardial perfusion after treatment (time frame: 40 weeks). 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 NCT04657939, 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 27 Feb 2023.