Maturity-Onset Diabetes of the Young, Type 3MOD3ST-CLAMPNCT05417646
Impact of SGLT2 on Glucosuria in HNF1A-MODY
A study testing Hyperglycaemic clamp and Empagliflozin in people with Maturity-Onset Diabetes of the Young, Type 3 and Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Maturity onset diabetes of the young (MODY) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. The most common cause of MODY is due to mutations in the gene hepatocyte nuclear factor 1 alpha (HNF1A) and is consequently named HNF1A-MODY (or MODY3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maturity-Onset Diabetes of the Young, Type 3, Type 2 Diabetes
- What is being tested?
- Hyperglycaemic clamp and Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Jun 2022to 14 Jun 2023
- Phase
- Interventional
- 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
- Age ≥18 years
- HNF1A-MODY verified by genetic testing (only patients with HNF1A-MODY)
- Type 2 diabetes diagnosis according to World Health Organization (only patients with type 2 diabetes)
- Treatment with diet and/or a glucose-lowering drug (only patients with HNF1A-MODY)
- Normal haemoglobin (males 8.3-10.5 mmol/l, females 7.3-9.5 mmol/l)
- Informed consent
Who cannot join
- Nephropathy (estimated GFR <60 ml/min/1.73m2 and/or albuminuria)
- Known significant liver disease and/or plasma alanine aminotransferase (ALT) and/or plasma aspartate aminotransferase (AST) above 2 × normal values)
- Pregnancy or breastfeeding
- Treatment with SGLT2 inhibitor
- Fasting plasma glucose > 10 mmol/l
- Family history of HNF1A-MODY (only patients with type 2 diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Maturity onset diabetes of the young (MODY) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. The most common cause of MODY is due to mutations in the gene hepatocyte nuclear factor 1 alpha (HNF1A) and is consequently named HNF1A-MODY (or MODY3). HNF1A-MODY is associated with urinary excretion of glucose at lower blood glucose levels compared to other types of diabetes. Normally, glucose is reabsorbed by sodium-glucose cotransporter 2 (SGLT2), but SGLT2 is downregulated due to the mutation in HNF1A. Investigators aim to evaluate the impact of the decreased expression of SGLT2 on glucosuria in patients with HNF1A-MODY compared to patients with type 2 diabetes (T2D) using a single dose of an SGLT2 inhibitor during a glucose clamp experiment.
Read the detailed description
Participants: Patients with HNF1A-MODY (n=12) and patients with T2D (n=12)
- Being tested
- Hyperglycaemic clamp, Placebo, Empagliflozin
- Keywords
- Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors, Glycosuria
- Medical subject headings
- Maturity-Onset Diabetes of the Young, Type 3, Diabetes Mellitus, Type 2, Glycosuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperglycaemic clampOther
Three-hour, three-step glucose clamp with plasma glucose targets 10, 14 and 18 mmol/l (each one hour)
PlaceboDrug
Placebo comparator to empagliflozin
EmpagliflozinDrug
Single-dose, 25 mg, two hours before clamp
| Study group | Role | What they receive |
|---|---|---|
| HNF1A-MODY - SGLT2 inhibition | Active comparator | 3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp) Receives: Other: Hyperglycaemic clamp; Drug: Empagliflozin |
| HNF1A-MODY - Placebo | Placebo comparator | 3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin) Receives: Other: Hyperglycaemic clamp; Drug: Placebo |
| Type 2 Diabetes - SGLT2 inhibition | Active comparator | 3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp) Receives: Other: Hyperglycaemic clamp; Drug: Empagliflozin |
| Type 2 Diabetes - Placebo | Placebo comparator | 3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin) Receives: Other: Hyperglycaemic clamp; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary glucose excretion
Measured: Assesed during 3 hour hyperglycaemic clamp
Secondary outcomes (8)
Urinary glucose excretion adjusted for glomerular filtration rate (GFR)
GFR: 99mTc-diethylenetriaminepentaacetic acid (99mTc-DTPA) plasma clearance
Measured: Assesed during 3 hour hyperglycaemic clamp
Infused amount of glucose
Measured: Assesed during 3 hour hyperglycaemic clamp
Urine volume
Measured: Assesed during 3 hour hyperglycaemic clamp
Glucose tissue disposal
difference between infused and excreted glucose
Measured: Assesed during 3 hour hyperglycaemic clamp
Urinary creatinine clearance
Urinary creatinine clearance calculated by plasma creatinine concentration and urinary creatinine excretion
Measured: Assesed during 3 hour hyperglycaemic clamp
Concentration of plasma c-peptide
Summarized as area under the curve (AUC)
Measured: Assesed during 3 hour hyperglycaemic clamp
Concentration of plasma glucagon
Summarized as AUC
Measured: Assesed during 3 hour hyperglycaemic clamp
Renal threshold of glucose excretion
Estimated using plasma glucose concentrations, urinary glucose excretion and GFR
Measured: Assesed during 3 hour hyperglycaemic clamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start22 Jun 2022
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maturity-Onset Diabetes of the Young, Type 3Studies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Tina Vilsbøll, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417646
- Sponsor's protocol ID
- H-21066984
- Acronym
- MOD3ST-CLAMP
- Status last verified
- Jul 2023
- First submitted
- 24 May 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Impact of SGLT2 on Glucosuria in HNF1A-MODY
- ClinicalTrials.gov ID
- NCT05417646
- Acronym / sponsor ID
- MOD3ST-CLAMP / H-21066984
- Keywords
- Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors, Glycosuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 14 Jun 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.
Maturity onset diabetes of the young (MODY) is a subtype of diabetes which is caused by mutations in specific genes leading to diabetes. The most common cause of MODY is due to mutations in the gene hepatocyte nuclear factor 1 alpha (HNF1A) and is consequently named HNF1A-MODY (or MODY3). HNF1A-MODY is associated with urinary excretion of glucose at lower blood glucose levels compared to other types of diabetes. Normally, glucose is reabsorbed by sodium-glucose cotransporter 2 (SGLT2), but SGLT2 is downregulated due to the mutation in HNF1A. Investigators aim to evaluate the impact of the decreased expression of SGLT2 on glucosuria in patients with HNF1A-MODY compared to patients with type 2 diabetes (T2D) using a single dose of an SGLT2 inhibitor during a glucose clamp experiment.
Detailed description
Participants: Patients with HNF1A-MODY (n=12) and patients with T2D (n=12)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HNF1A-MODY - SGLT2 inhibition | Active comparator | Other: Hyperglycaemic clamp, Drug: Empagliflozin3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp) |
| HNF1A-MODY - Placebo | Placebo comparator | Other: Hyperglycaemic clamp, Drug: Placebo3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin) |
| Type 2 Diabetes - SGLT2 inhibition | Active comparator | Other: Hyperglycaemic clamp, Drug: Empagliflozin3-hour hyperglycemic clamp with inhibition of SGLT2 (single-dose empagliflozin 25 mg two hours before clamp) |
| Type 2 Diabetes - Placebo | Placebo comparator | Other: Hyperglycaemic clamp, Drug: Placebo3-hour hyperglycemic clamp without inhibition of SGLT2 (placebo comparator to empagliflozin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- HNF1A-MODY verified by genetic testing (only patients with HNF1A-MODY)
- Type 2 diabetes diagnosis according to World Health Organization (only patients with type 2 diabetes)
- Treatment with diet and/or a glucose-lowering drug (only patients with HNF1A-MODY)
- Normal haemoglobin (males 8.3-10.5 mmol/l, females 7.3-9.5 mmol/l)
Key exclusion criteria (6 listed)
- Nephropathy (estimated GFR <60 ml/min/1.73m2 and/or albuminuria)
- Known significant liver disease and/or plasma alanine aminotransferase (ALT) and/or plasma aspartate aminotransferase (AST) above 2 × normal values)
- Pregnancy or breastfeeding
- Treatment with SGLT2 inhibitor
- Fasting plasma glucose > 10 mmol/l
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 |
|---|---|---|
| Hyperglycaemic clampThree-hour, three-step glucose clamp with plasma glucose targets 10, 14 and 18 mmol/l (each one hour) | Other | HNF1A-MODY - Placebo, HNF1A-MODY - SGLT2 inhibition, Type 2 Diabetes - Placebo, Type 2 Diabetes - SGLT2 inhibition |
| PlaceboPlacebo comparator to empagliflozin | Drug | HNF1A-MODY - Placebo, Type 2 Diabetes - Placebo |
| EmpagliflozinSingle-dose, 25 mg, two hours before clamp | Drug | HNF1A-MODY - SGLT2 inhibition, Type 2 Diabetes - SGLT2 inhibition |
Primary outcome
Urinary glucose excretion
Time frame: Assesed during 3 hour hyperglycaemic clamp
8 secondary outcomes
Urinary glucose excretion adjusted for glomerular filtration rate (GFR)
Time frame: Assesed during 3 hour hyperglycaemic clamp
Infused amount of glucose
Time frame: Assesed during 3 hour hyperglycaemic clamp
Urine volume
Time frame: Assesed during 3 hour hyperglycaemic clamp
Glucose tissue disposal
Time frame: Assesed during 3 hour hyperglycaemic clamp
Urinary creatinine clearance
Time frame: Assesed during 3 hour hyperglycaemic clamp
Concentration of plasma c-peptide
Time frame: Assesed during 3 hour hyperglycaemic clamp
Concentration of plasma glucagon
Time frame: Assesed during 3 hour hyperglycaemic clamp
Renal threshold of glucose excretion
Time frame: Assesed during 3 hour hyperglycaemic clamp
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.
- 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.
Tina Vilsbøll principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperglycaemic clamp and Empagliflozin in people with Maturity-Onset Diabetes of the Young, Type 3 and Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 6 inclusion and 6 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Urinary glucose excretion (time frame: Assesed during 3 hour hyperglycaemic clamp). 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.