Diabetes Mellitus Type 1Phase 2EXTYPE-1NCT02127047
Effects of Exercise and Inhibition of Dipeptidyl Peptidase-4 on Insulin Secretion in Subjects With Type 1 Diabetes
A Phase 2 study testing Sitagliptin and Exercise in people with Diabetes Mellitus Type 1, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass in type 1 diabetes may be improved through inhibition of beta-cell destruction and stimulation of proliferation, even after prolonged… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Sitagliptin and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to 5 Aug 2016
- Phase
- Phase 2
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes (American Diabetes Association criteria) of > 2 year duration that is judged to be stable by the investigator
- No clinically significant change in treatment regimen for type 1 diabetes (defined as a 20% change) during the 3 months prior to Screening
- Positive glutamic acid decarboxylase 65 and/or Islet Antigen (IA)-2 auto-antibodies
- Age ≥ 18 years and ≤ 55 years
- HbA1c < 7.5% for the previous two measurements including the measurement taken at Screening (both measurements must occur within 6 months prior to enrollment)
- Body-mass index (BMI) > 18 and < 28 kg/m2
- Willingness to maintain current doses/regimens of vitamins and dietary supplements through the end of the study
- For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study. Adequate contraceptive measures include hormonal methods used for two or more cycles prior to Screening (e.g., oral contraceptive pills, contraceptive patch, or contraceptive vaginal ring), double barrier methods (e.g., contraceptive sponge, diaphragm used in conjunction with contraceptive foam or jelly, and condom used in conjunction with contraceptive foam or jelly), intrauterine methods (IUD), sterilization (e.g., tubal ligation or a monogamous relationship with a vasectomized partner), and abstinence.
Who cannot join
- Regular training of more than 90 minutes / week
- History or signs of cardiovascular disease, proliferative retinopathy, nephropathy or neuropathy
- Signs of current infection
- Neutropenia
- Anemia
- Clinically significant kidney or liver disease
- Current immunosuppressive treatment or documented immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass in type 1 diabetes may be improved through inhibition of beta-cell destruction and stimulation of proliferation, even after prolonged duration of disease.
Physical activity improves insulin secretion via unknown underlying mechanisms. We recently observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels. Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1 secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how physical activity can help maintain and improve beta-cell function in patients with type 1 diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition.
Read more
Physical activity is also known to enhance insulin sensitivity and to attenuate the immune system activity.
Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to allow for beta-cell regeneration in a interventional randomized open-label study.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Sitagliptin, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
ExerciseDrug
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin | Experimental | Patients receive Sitagliptin (100mg/d) without further intervention Receives: Drug: Sitagliptin |
| Sitagliptin and exercise | Experimental | Patients receive sitagliptin (100mg/d) and follow a physical training intervention program Receives: Drug: Sitagliptin; Drug: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in beta-cell function as derived from change in C-peptide and glucose levels during the mixed meal test
Measured: Day 90 compared to baseline (Day 1 pre-dose)
Secondary outcomes (15)
Change in insulin sensitivity as derived from change in C-peptide and glucose levels during the mixed meal test
Measured: Day 90 compared to baseline (Day 1 pre-dose)
Change in insulin requirements: 3-day average daily insulin dose
Measured: baseline (Day -3 through Day -1) compared to Day 90 (Day 87 through Day 89)
Change in HbA1c levels
Measured: baseline (Day 1 pre-dose) at Day 90
Change in fasting glucose
Measured: baseline (Day 1 pre-dose) at Day 90
Change in fasting glucagon and cortisol
Measured: baseline (Day 1 pre-dose) at Day 90
Change in total number of hypoglycemic events compared to treatment groups
Measured: baseline (Day 1 pre-dose) to Day 90
Change in markers of systemic inflammation
Measured: from baseline (Day 1 pre-dose) at Day 90
Change in composition of immune cells
Measured: from baseline at Day 90
Change in meal-stimulated GLP-1 and gastric inhibitory peptide
Measured: Day 90 compared to baseline
Change in lipids profile
Measured: baseline at Day 90
Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions questionnaire
Measured: from baseline at Day 90
Change in plasma copeptin and procalcitonin levels
Measured: from baseline (Day 1 pre-dose) at Day 90
Change in retinal vascular diameter
Measured: Day 90 compared to baseline (Day 1 pre-dose)
Change in arterial stiffness
Measured: Day 90 compared to baseline (Day 1 pre-dose)
Change in fractalkine
Measured: Day 90 compared to baseline (Day 1 pre-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionJul 2016
- Study completion5 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Donath, Prof. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127047
- Sponsor's protocol ID
- EKBB 349/12
- Acronym
- EXTYPE-1
- Status last verified
- Jul 2017
- First submitted
- 28 Apr 2014
- Last updated
- 27 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise and Inhibition of Dipeptidyl Peptidase-4 on Insulin Secretion in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02127047
- Acronym / sponsor ID
- EXTYPE-1 / EKBB 349/12
- Conditions
- Diabetes Mellitus Type 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- 5 Aug 2016 (actual)
- First posted
- 30 Apr 2014 (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.
Increasing evidence suggests pancreatic islet beta-cell regeneration occurs throughout the course of the disease in patients with type 1 diabetes. Therefore, decreased beta-cell mass in type 1 diabetes may be improved through inhibition of beta-cell destruction and stimulation of proliferation, even after prolonged duration of disease.
Physical activity improves insulin secretion via unknown underlying mechanisms. We recently observed that Interleukin-6 induces glucagon like Peptide (GLP)-1 production and release from the islet alpha-cell and the intestinal L-cell. Furthermore, exercise induces release of Interleukin-6 from skeletal muscle resulting in elevated circulating Interleukin-6 levels. Therefore we hypothesize that exercise-induced Interleukin-6 promotes glucagon like peptide-1 secretion from the islet α-cell and the intestinal L-cell, thereby providing a mechanism how physical activity can help maintain and improve beta-cell function in patients with type 1 diabetes. This mechanism can be enhanced by concomitant dipeptidyl peptidase-IV inhibition.
Physical activity is also known to enhance insulin sensitivity and to attenuate the immune system activity.
Therefore by combining physical activity and dipeptidyl peptidase-IV inhibition we aim to allow for beta-cell regeneration in a interventional randomized open-label study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin | Experimental | Drug: SitagliptinPatients receive Sitagliptin (100mg/d) without further intervention |
| Sitagliptin and exercise | Experimental | Drug: Sitagliptin, Drug: ExercisePatients receive sitagliptin (100mg/d) and follow a physical training intervention program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Type 1 diabetes (American Diabetes Association criteria) of > 2 year duration that is judged to be stable by the investigator
- No clinically significant change in treatment regimen for type 1 diabetes (defined as a 20% change) during the 3 months prior to Screening
- Positive glutamic acid decarboxylase 65 and/or Islet Antigen (IA)-2 auto-antibodies
- Age ≥ 18 years and ≤ 55 years
- HbA1c < 7.5% for the previous two measurements including the measurement taken at Screening (both measurements must occur within 6 months prior to enrollment)
Key exclusion criteria (7 listed)
- Regular training of more than 90 minutes / week
- History or signs of cardiovascular disease, proliferative retinopathy, nephropathy or neuropathy
- Signs of current infection
- Neutropenia
- Anemia
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 |
|---|---|---|
| Sitagliptin | Drug | Sitagliptin, Sitagliptin and exercise |
| Exercise | Drug | Sitagliptin and exercise |
Primary outcome
Change in beta-cell function as derived from change in C-peptide and glucose levels during the mixed meal test
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
15 secondary outcomes
Change in insulin sensitivity as derived from change in C-peptide and glucose levels during the mixed meal test
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Change in insulin requirements: 3-day average daily insulin dose
Time frame: baseline (Day -3 through Day -1) compared to Day 90 (Day 87 through Day 89)
Change in HbA1c levels
Time frame: baseline (Day 1 pre-dose) at Day 90
Change in fasting glucose
Time frame: baseline (Day 1 pre-dose) at Day 90
Change in fasting glucagon and cortisol
Time frame: baseline (Day 1 pre-dose) at Day 90
Change in total number of hypoglycemic events compared to treatment groups
Time frame: baseline (Day 1 pre-dose) to Day 90
Change in markers of systemic inflammation
Time frame: from baseline (Day 1 pre-dose) at Day 90
Change in composition of immune cells
Time frame: from baseline at Day 90
Change in meal-stimulated GLP-1 and gastric inhibitory peptide
Time frame: Day 90 compared to baseline
Change in lipids profile
Time frame: baseline at Day 90
Change in fatigue according to the Fatigue Scale for Motor and Cognitive Functions questionnaire
Time frame: from baseline at Day 90
Change in plasma copeptin and procalcitonin levels
Time frame: from baseline (Day 1 pre-dose) at Day 90
Change in retinal vascular diameter
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Change in arterial stiffness
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
Change in fractalkine
Time frame: Day 90 compared to baseline (Day 1 pre-dose)
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 2017.
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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.
Marc Donath, Prof. MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sitagliptin and Exercise in people with Diabetes Mellitus Type 1, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 7 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 2017. 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 beta-cell function as derived from change in C-peptide and glucose levels during the mixed meal test (time frame: Day 90 compared to baseline (Day 1 pre-dose)). 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 2017.