Maturity-onset Diabetes of the YoungPhase 2/3NCT01610934
The Effects of GLP-1 in Maturity-Onset Diabetes of The Young (MODY)
A Phase 2/3 study testing liraglutide and Glimepiride in people with Maturity-onset Diabetes of the Young, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment. 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
- What is being tested?
- liraglutide and Glimepiride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Aug 2013
- Phase
- Phase 2/3
- 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
- Caucasian above 18 years of age
- Well characterised MODY3
- Body mass index (BMI) > 19 kg/m2
- Normal haemoglobin (males > 8.2 mM, females > 7.2 mM)
- Normal blood pressure (< 160/100 mmHg)
- Informed consent
- Capability to perform a light cycling test (heart rate 100-120 beats per minute during 30 minutes)
- Females: use of anticonception (IUC or hormonal)
Who cannot join
- Heart failure: New York Heart Association class III-IV
- Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria
- Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) > 2 × upper normal serum levels)
- Anaemia
- Acute or chronic pancreatitis
- Stroma or thyroid cancer
Show all 13Show fewer
- Pregnancy or breast feeding
- Inability to complete the study
- Treatment naïve patients with HbA1c < 7.0 %
- Treatment with medicine that can not be paused for 12 hours
- Known allergic reaction to study medication
- Intention to become pregnant
- Unwillingness to complete the protocol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Diabetes research Division, University Hospital Gentofte
Hellerup, 2900
About this study
Official title: Phase 2 Study: A Double-blind, Randomised, Clinical Cross-over Trial to Investigate the Treatment Potential of Liraglutide Compared to Glimepiride in MODY Patients
The purpose of this study is to evaluate the treatment potential of GLP-1-analogues in patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.
Read the detailed description
Maturity-onset diabetes of the young (MODY) is a monogenic form of diabetes responsible for approximately 1-2% of all cases of diabetes. The disease is clinically defined by: 1) autosomal dominant inheritance (diabetes for at least two consecutive generations), 2) non-insulin dependent diabetes at onset (or measurable serum C-peptide three years after onset), and 3) diagnosis in a young age (at least one family member with onset before the age of 25 years). Clinically, MODY-patients resemble patients with type 2 diabetes (T2DM) more than patients with type 1 diabetes mellitus (T1DM). MODY is genetically heterogeneous, with known mutations in eight different genes and mutations in either of these genes leads to specific forms of MODY. Based on a national epidemiological survey, we know that in Denmark, approximately 50% of patients who are diagnosed with MODY have mutations in the hepatocyte nuclear factor (HNF) 4 alpha (HNF4A) (MODY1), glucokinase (GCK) (MODY2), or HNF1A (MODY3) genes.
MODY3 is the most common form of MODY in Denmark (approximately 60% of all patients with MODY). Patients with MODY3 are often diagnosed around puberty, more than 50% of mutation carriers will develop diabetes before the age of 25, and the lifetime risk of developing diabetes is higher than 95%. The typical course of disease is characterised by a rapid progression from impaired glucose tolerance to diabetes. After the diagnosis of diabetes, the glucose tolerance is further impaired due to a continuous loss of beta cell function. MODY3 often develops abruptly with classic hyperglycaemic symptoms such as polyuria and polydipsia, which is why this form of diabetes is often misclassified as T1DM. Patients with MODY3 have the same risk of developing microvascular and macrovascular late diabetic complications as patients with T2DM, and, strict glycaemic control combined with proper screening for diabetic late complications is crucial for a good prognosis.
About half of MODY3 patients are treated with diet or oral antidiabetic agents, the latter mostly in the form of sulphonylureas (SU), which, if possible is preferred to insulin injections. Due to a high sensitivity to SU combined with normal or even increased insulin sensitivity (MODY3 patients are more insulin sensitive than age- and body mass index (BMI)-matched patients with T2DM), this treatment is often associated with hypoglycaemia even when rather low doses of SU are used. Although SU treatment offhand seems to constitute a logical choice of treatment in MODY, due to beta cell dysfunction, the risk of hypoglycaemia is a clinical drawback due to potential suboptimal glycaemic control and decreased patient compliance. In a recent study, in which patients with MODY3 were exposed to physical activity (light cycling for 30 minutes approximately 2 hours after meal ingestion), hypoglycaemia was observed in 40% of subjects treated with short-acting SU (glibenclamide) with one patient experiencing hypoglycaemia for 12 hours.
Glucagon-like peptide-1 (GLP-1) is an incretin hormone, which is secreted from endocrine L cells of the small intestine in response to nutrients in the gut lumen. GLP-1 conveys an insulinotropic effect through GLP-1 receptors (GLP-1R) on pancreatic beta cells thereby decreasing plasma glucose (PG). Moreover, GLP-1 inhibits the secretion of glucagon from pancreatic alpha cells, which further contributes to lowering of the PG levels. Both of these effects are strictly glucose-dependent (more pronounced at higher PG levels) and the effects cease as PG levels reaches values below 4-5 mM. Therefore, the hormones keep PG at normal levels without increasing the risk of hypoglycaemia. In addition, GLP-1 inhibits gastrointestinal motility including gastric emptying and leads to a centrally-mediated inhibition of appetite resulting in reduced food intake. Thus, GLP-1 is essential for glycaemic control. The GLP-1R agonist, liraglutide (Victoza®), has 97% homology to the naturally occurring GLP-1 hormone, but has a longer half-life (11-15 hours).
Since the effects of the incretin hormones are strictly glucose-dependent, treatment with GLP-1R agonists is rarely associated with hypoglycaemia. Thus, the current study aims to elucidate whether liraglutide (Victoza®) could be a safe and efficacious new treatment modality for patients with MODY.
- Conditions
- Maturity-onset Diabetes of the Young
- Being tested
- liraglutide, Glimepiride
- Keywords
- MODY, Monogenic diabetes, Non-autoimmune diabetes, MODY3
- Medical subject headings
- Mason-Type Diabetes, Diabetes Mellitus, Type 2, Maturity-Onset Diabetes of the Young, Type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called Victoza®
The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.8 mg liraglutide will remain on 1.2 mg of liraglutide. The injection is administered once daily in the morning.
GlimepirideDrug
Also called Amaryl®
At randomisation patients will be initiated on their pre-study daily dose of glimepiride minus 0.5 mg. After one week the dose will be titrated (see below). Drug naïve patients will be initiated on an initial dosage of glimepiride of 0.5 mg for one week. Thereafter, glimepiride is increased to 1.0 mg and after another one week to 1.5 mg, and there after further up to 3 mg (if the average FPG during one week is above 6 mM). The dose of glimepiride can be increased up to 4 mg if average FPG is above 6 mM and no symptoms of hypoglycaemia are observed.
| Study group | Role | What they receive |
|---|---|---|
| liraglutide | Experimental | Not described Receives: Drug: liraglutide |
| glimepiride | Active comparator | Not described Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose
Glycaemic control will be evaluated by FPG monitored twice weekly, 7-point PG profiles every two weeks and 3 blinded 48-hour continuous PG profiles (before randomisation and at the end of both treatment periods). The patients who will be their own controls, will randomly be assigned (after one week washout of usual antidiabetic treatment) to receive either liraglutide or glimepiride for 6 weeks, and after another one-week washout period treated with the opposite treatment for 6 weeks.
Measured: 14 weeks
Secondary outcomes (5)
Serum Fructosamine
Fructosamine is a time-averaged indicator of PG levels. It reflects the total amount of glycated proteins such as glycohaemoglobin and glycoalbumin in a blood sample. The turnover of serum proteins (albumin has a half-life of 19 days) is less than that of haemoglobin, and therefore fructosamine determinations provide a means of monitoring patient blood glucose status over a shorter period (1-3 weeks) than glycohaemoglobin (6-8 weeks).
Measured: 14 weeks
Hypoglycemic events
Hypoglycaemic events will be reported by the patient in a diary. During cycling tests patients will be tested further according to hypoglycaemia. Mild hypoglycaemia is defined as episodes with symptoms of hypoglycaemia familiar to the patient and managed solely by the patient. Events of severe hypoglycaemia are defined as episodes with symptoms of hypoglycaemia with need for assistance from another person.
Measured: 14 weeks
Plasma concentrations of insulin and C-peptide
Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period).
Measured: 14 weeks
Plasma glucagon
Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period).
Measured: 14 weeks
Plasma concentrations of incretin hormones
Postprandial responses of incretin hormones and beta cell function (assessed as fasting proinsulin-to-insulin ratio) will be evaluated during three standardised 4-hour meal tests (at baseline and in the end of each treatment period).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Maturity-onset Diabetes of the YoungStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, University of Copenhagen
- Responsible party
- Principal investigator, Signe H Østoft, MD, University Hospital, Gentofte, Copenhagen
- Investigators
- Signe H Østoft, MD, Principal investigator, Diabetes Research Division, University Hospital Gentofte, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610934
- Sponsor's protocol ID
- MODY-TREAT
- Other IDs
- 2012-000592-17
- Status last verified
- Sep 2013
- First submitted
- 24 May 2012
- Last updated
- 5 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ostoft SH, Bagger JI, Hansen T, Pedersen O, Faber J, Holst JJ, Knop FK, Vilsboll T. Glucose-lowering effects and low risk of hypoglycemia in patients with maturity-onset diabetes of the young when treated with a GLP-1 receptor agonist: a double-blind, randomized, crossover trial. Diabetes Care. 2014 Jul;37(7):1797-805. doi: 10.2337/dc13-3007.
PubMed 24929431
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study: A Double-blind, Randomised, Clinical Cross-over Trial to Investigate the Treatment Potential of Liraglutide Compared to Glimepiride in MODY Patients
- ClinicalTrials.gov ID
- NCT01610934
- Acronym / sponsor ID
- MODY-TREAT
- Conditions
- Maturity-onset Diabetes of the Young
- Keywords
- MODY, Monogenic diabetes, Non-autoimmune diabetes, MODY3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, University of Copenhagen
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Jun 2012 (estimated)
- 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 purpose of this study is to evaluate the treatment potential of GLP-1-analogues in patients with Maturity Onset Diabetes of the Young (MODY) compared to common treatment.
Detailed description
Maturity-onset diabetes of the young (MODY) is a monogenic form of diabetes responsible for approximately 1-2% of all cases of diabetes. The disease is clinically defined by: 1) autosomal dominant inheritance (diabetes for at least two consecutive generations), 2) non-insulin dependent diabetes at onset (or measurable serum C-peptide three years after onset), and 3) diagnosis in a young age (at least one family member with onset before the age of 25 years). Clinically, MODY-patients resemble patients with type 2 diabetes (T2DM) more than patients with type 1 diabetes mellitus (T1DM). MODY is genetically heterogeneous, with known mutations in eight different genes and mutations in either of these genes leads to specific forms of MODY. Based on a national epidemiological survey, we know that in Denmark, approximately 50% of patients who are diagnosed with MODY have mutations in the hepatocyte nuclear factor (HNF) 4 alpha (HNF4A) (MODY1), glucokinase (GCK) (MODY2), or HNF1A (MODY3) genes.
MODY3 is the most common form of MODY in Denmark (approximately 60% of all patients with MODY). Patients with MODY3 are often diagnosed around puberty, more than 50% of mutation carriers will develop diabetes before the age of 25, and the lifetime risk of developing diabetes is higher than 95%. The typical course of disease is characterised by a rapid progression from impaired glucose tolerance to diabetes. After the diagnosis of diabetes, the glucose tolerance is further impaired due to a continuous loss of beta cell function. MODY3 often develops abruptly with classic hyperglycaemic symptoms such as polyuria and polydipsia, which is why this form of diabetes is often misclassified as T1DM. Patients with MODY3 have the same risk of developing microvascular and macrovascular late diabetic complications as patients with T2DM, and, strict glycaemic control combined with proper screening for diabetic late complications is crucial for a good prognosis.
About half of MODY3 patients are treated with diet or oral antidiabetic agents, the latter mostly in the form of sulphonylureas (SU), which, if possible is preferred to insulin injections. Due to a high sensitivity to SU combined with normal or even increased insulin sensitivity (MODY3 patients are more insulin sensitive than age- and body mass index (BMI)-matched patients with T2DM), this treatment is often associated with hypoglycaemia even when rather low doses of SU are used. Although SU treatment offhand seems to constitute a logical choice of treatment in MODY, due to beta cell dysfunction, the risk of hypoglycaemia is a clinical drawback due to potential suboptimal glycaemic control and decreased patient compliance. In a recent study, in which patients with MODY3 were exposed to physical activity (light cycling for 30 minutes approximately 2 hours after meal ingestion), hypoglycaemia was observed in 40% of subjects treated with short-acting SU (glibenclamide) with one patient experiencing hypoglycaemia for 12 hours.
Glucagon-like peptide-1 (GLP-1) is an incretin hormone, which is secreted from endocrine L cells of the small intestine in response to nutrients in the gut lumen. GLP-1 conveys an insulinotropic effect through GLP-1 receptors (GLP-1R) on pancreatic beta cells thereby decreasing plasma glucose (PG). Moreover, GLP-1 inhibits the secretion of glucagon from pancreatic alpha cells, which further contributes to lowering of the PG levels. Both of these effects are strictly glucose-dependent (more pronounced at higher PG levels) and the effects cease as PG levels reaches values below 4-5 mM. Therefore, the hormones keep PG at normal levels without increasing the risk of hypoglycaemia. In addition, GLP-1 inhibits gastrointestinal motility including gastric emptying and leads to a centrally-mediated inhibition of appetite resulting in reduced food intake. Thus, GLP-1 is essential for glycaemic control. The GLP-1R agonist, liraglutide (Victoza®), has 97% homology to the naturally occurring GLP-1 hormone, but has a longer half-life (11-15 hours).
Since the effects of the incretin hormones are strictly glucose-dependent, treatment with GLP-1R agonists is rarely associated with hypoglycaemia. Thus, the current study aims to elucidate whether liraglutide (Victoza®) could be a safe and efficacious new treatment modality for patients with MODY.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liraglutide | Experimental | Drug: liraglutide |
| glimepiride | Active comparator | Drug: Glimepiride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Caucasian above 18 years of age
- Well characterised MODY3
- Body mass index (BMI) > 19 kg/m2
- Normal haemoglobin (males > 8.2 mM, females > 7.2 mM)
- Normal blood pressure (< 160/100 mmHg)
Key exclusion criteria (13 listed)
- Heart failure: New York Heart Association class III-IV
- Uraemia, end-stage renal disease, or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria
- Liver disease (alanine amino transferase (ALAT) and/or aspartate amino transferase (ASAT) > 2 × upper normal serum levels)
- Anaemia
- Acute or chronic pancreatitis
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 |
|---|---|---|
| liraglutideAlso: Victoza®The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.8 mg liraglutide will remain on 1.2 mg of liraglutide. The injection is administered once daily in the morning. | Drug | liraglutide |
| GlimepirideAlso: Amaryl®At randomisation patients will be initiated on their pre-study daily dose of glimepiride minus 0.5 mg. After one week the dose will be titrated (see below). Drug naïve patients will be initiated on an initial dosage of glimepiride of 0.5 mg for one week. Thereafter, glimepiride is increased to 1.0 mg and after another one week to 1.5 mg, and there after further up to 3 mg (if the average FPG during one week is above 6 mM). The dose of glimepiride can be increased up to 4 mg if average FPG is above 6 mM and no symptoms of hypoglycaemia are observed. | Drug | glimepiride |
Primary outcome
Fasting Plasma Glucose
Time frame: 14 weeks
Glycaemic control will be evaluated by FPG monitored twice weekly, 7-point PG profiles every two weeks and 3 blinded 48-hour continuous PG profiles (before randomisation and at the end of both treatment periods). The patients who will be their own controls, will randomly be assigned (after one week washout of usual antidiabetic treatment) to receive either liraglutide or glimepiride for 6 weeks, and after another one-week washout period treated with the opposite treatment for 6 weeks.
5 secondary outcomes
Serum Fructosamine
Time frame: 14 weeks
Hypoglycemic events
Time frame: 14 weeks
Plasma concentrations of insulin and C-peptide
Time frame: 14 weeks
Plasma glucagon
Time frame: 14 weeks
Plasma concentrations of incretin hormones
Time frame: 14 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 5 Sep 2013.
- Derived from this study: PubMed 24929431Ostoft SH, Bagger JI, Hansen T, Pedersen O, Faber J, Holst JJ, Knop FK, Vilsboll T. Glucose-lowering effects and low risk of hypoglycemia in patients with maturity-onset diabetes of the young when treated with a GLP-1 receptor agonist: a double-blind, randomized, crossover trial. Diabetes Care. 2014 Jul;37(7):1797-805. doi: 10.2337/dc13-3007.
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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.
Signe H Østoft, MD principal investigator
Diabetes Research Division, University Hospital Gentofte, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing liraglutide and Glimepiride in people with Maturity-onset Diabetes of the Young, run by University Hospital, Gentofte, 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 8 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: finished, as of the sponsor's last update on 5 Sep 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Fasting Plasma Glucose (time frame: 14 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 NCT01610934, 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 5 Sep 2013.