Type 2 DiabetesDiaSpaxNCT05501483
Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes
A study testing Pioglitazone 45 mg, Empagliflozin 25 MG and Semaglutide 7 MG in people with Type 2 Diabetes, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
People with newly diagnosed type 2 diabetes treated with metformin that have not reached their HbA1c target (42-64 mmol/mol) will be recruited to the study. If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Pioglitazone 45 mg, Empagliflozin 25 MG and Semaglutide 7 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2023to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- BMI 25 kg/m2 or higher
- HbA1c 42 mmol/mol or higher
- For fertile women, effective contraception
Who cannot join
- HbA1c 65 mmol/mol or higher
- Established cardiovascular disease and/or heart failure
- Severe psychiatric condition
- Active alcoholism
- Insulin treatment
- Anticoagulant therapy (vitamin K antagonists or equivalent)
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- Pregnancy, lactation
- Positive GAD or IA2 antibodies
- Low C-peptide/glucose ratio (less than 2 measured as pmol/mg per dL)
- NT-proBNP above the upper normal reference value
- Kidney disease
- Liver disease or hepatic values over twice the upper reference value
- Severe concomitant disease including ongoing cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Mikael Rydén, MD, PhD, 0736995215, mikael.ryden@ki.se
Jesper Bäckdahl, MD, PhD, +46702297237, jesper.backdahl@ki.se
About this study
Official title: Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
People with newly diagnosed type 2 diabetes treated with metformin that have not reached their HbA1c target (42-64 mmol/mol) will be recruited to the study. If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide. Fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months. Participants are regularly followed during this the intervention. The overall goal is to determine how antidiabetic-drugs affect white adipose tissue cellularity and whether adipose heterogeneity impacts on drug response. The primary outcome measure is the change in fat tissue lipolysis (glycerol release in isolated fat cells after hormone stimulation) before and after treatment.
Read the detailed description
A detailed description of the protocol has been approved by the Swedish Medical Products Agency and the study is registered as EudraCT: 2021-002367-21.
- Conditions
- Type 2 Diabetes
- Being tested
- Pioglitazone 45 mg, Empagliflozin 25 MG, Semaglutide 7 MG
- 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.
Pioglitazone 45 mgDrug
Starts with 45 mg
Empagliflozin 25 MGDrug
Starts with 25 mg
Semaglutide 7 MGDrug
Starts with 3 mg daily for the first 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Active comparator | Pioglitazone is known to affect fat cells and is used as an active comparator. It reduces HbA1c but increase fat mass slightly. We hypothesize that pioglitazone may have particular benefits in individuals with a specific adipose cellularity. Receives: Drug: Pioglitazone 45 mg |
| Empagliflozin | Experimental | Empagliflozin reduces HbA1c and increase lipolysis possibly due to increased glucagon secretion. It also reduces fat mass weight to a minor degree. Receives: Drug: Empagliflozin 25 MG |
| Semaglutide | Experimental | Semaglutide reduces body weight, including fat mass, to a more significant degree than empagliflozin but has no known direct effects on adipose tissue. Receives: Drug: Semaglutide 7 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fat cell lipolysis after 6 months of treatment
Change in isoprenaline-induced (over basal) lipolysis in isolated fat cells
Measured: Baseline and after six months intervention
Secondary outcomes (1)
Changes in fat cell heterogeneity after 6 months of treatment
Changes in the adiponectin/leptin mRNA expression ratio in adipose tissue measured by quantitative PCR
Measured: Baseline and after six months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start8 Feb 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are recruited to either of three groups where they receive (in addition to metformin) any of the three study drugs.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Mikael Ryden, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501483
- Sponsor's protocol ID
- Karolinska University Hospital
- Other IDs
- 2022-00792 and 2024-03434, 2021-002367-21
- Acronym
- DiaSpax
- Status last verified
- Feb 2025
- First submitted
- 10 Aug 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the ethical approval, we are not allowed to share participant data that can allow identification of the individual participants. We will present data at a group level and anonymized data in the publications that are planned to result from this study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Tissue Heterogeneity and Its Link to Type 2 Diabetes: A Randomized Open Intervention Study That Compares Empagliflozin, Pioglitazone and Semaglutide
- ClinicalTrials.gov ID
- NCT05501483
- Acronym / sponsor ID
- DiaSpax / Karolinska University Hospital
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 15 Aug 2022 (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.
People with newly diagnosed type 2 diabetes treated with metformin that have not reached their HbA1c target (42-64 mmol/mol) will be recruited to the study. If they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide. Fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months. Participants are regularly followed during this the intervention. The overall goal is to determine how antidiabetic-drugs affect white adipose tissue cellularity and whether adipose heterogeneity impacts on drug response. The primary outcome measure is the change in fat tissue lipolysis (glycerol release in isolated fat cells after hormone stimulation) before and after treatment.
Detailed description
A detailed description of the protocol has been approved by the Swedish Medical Products Agency and the study is registered as EudraCT: 2021-002367-21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are recruited to either of three groups where they receive (in addition to metformin) any of the three study drugs.
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: Pioglitazone 45 mgPioglitazone is known to affect fat cells and is used as an active comparator. It reduces HbA1c but increase fat mass slightly. We hypothesize that pioglitazone may have particular benefits in individuals with a specific adipose cellularity. |
| Empagliflozin | Experimental | Drug: Empagliflozin 25 MGEmpagliflozin reduces HbA1c and increase lipolysis possibly due to increased glucagon secretion. It also reduces fat mass weight to a minor degree. |
| Semaglutide | Experimental | Drug: Semaglutide 7 MGSemaglutide reduces body weight, including fat mass, to a more significant degree than empagliflozin but has no known direct effects on adipose tissue. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- BMI 25 kg/m2 or higher
- HbA1c 42 mmol/mol or higher
- For fertile women, effective contraception
Key exclusion criteria (13 listed)
- HbA1c 65 mmol/mol or higher
- Established cardiovascular disease and/or heart failure
- Severe psychiatric condition
- Active alcoholism
- Insulin treatment
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 |
|---|---|---|
| Pioglitazone 45 mgStarts with 45 mg | Drug | Pioglitazone |
| Empagliflozin 25 MGStarts with 25 mg | Drug | Empagliflozin |
| Semaglutide 7 MGStarts with 3 mg daily for the first 2 weeks | Drug | Semaglutide |
Primary outcome
Changes in fat cell lipolysis after 6 months of treatment
Time frame: Baseline and after six months intervention
Change in isoprenaline-induced (over basal) lipolysis in isolated fat cells
1 secondary outcome
Changes in fat cell heterogeneity after 6 months of treatment
Time frame: Baseline and after six months intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: No. According to the ethical approval, we are not allowed to share participant data that can allow identification of the individual participants. We will present data at a group level and anonymized data in the publications that are planned to result from this study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone 45 mg, Empagliflozin 25 MG and Semaglutide 7 MG in people with Type 2 Diabetes, run by Karolinska Institutet at 1 site in Sweden.
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 13 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Ryden, MD, PhD (+46736995215, mikael.ryden@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in fat cell lipolysis after 6 months of treatment (time frame: Baseline and after six months intervention). 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 26 Feb 2025.