Type 2 DiabetesPhase 4NCT01426737
The Swiss Glucose Variability Study
A Phase 4 study testing Vildagliptin in people with Type 2 Diabetes, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose of this study is to explore long term glucose variability of a combination therapy of metformin and vildagliptin compared to a metformin - gliclazide combination. Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration. Trial with medicinal product Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vildagliptin
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2011to Jan 2013
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged =30 -= 75 years.
- History of type 2 diabetes for at least 6 months.
- Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with HbA1c of 6.5-9.0%.
- Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with a body mass index (BMI) of 25-40 kg/m2.
- Patients that are currently treated with metformin, gliclazide or both but not with other glucose lowering agents.
- Outpatient.
- If female of childbearing potential: Will to practice reliable birth control measures [e.g., surgical sterilization, hormonal contraception, double-barrier methods (any double combination of IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)] during study treatment and for at least 28 days after completion of study medication; not lactating or pregnant; and has a documented negative pregnancy test result at baseline.
Who cannot join
- Type 1 diabetes as defined by the American Diabetes Association (ADA).
- Type 2 diabetes currently (last 3 months) treated with insulin or glitazones.
- Acute or chronic diseases causing tissue hypoxia such as:
- cardiac or respiratory insufficiency
- myocardial infarct within the last 6 months
- Active liver disease with alanine aminotransferase (ALAT) and / or aspartate aminotransferase (ASAT) > 3 x upper limit of normal.
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- Relevant kidney disease such as :
- serum creatinine =133 µmol/l in males and > 124 µmol/l in females
- proteinuria > 300 mg/l
- status post kidney transplantation
- severe infection
- intravascular administration of contrast medium containing iod within the last 7 days
- Severe neuropathy (vibration perception at the base of the big toes <2/8).
- Active proliferative diabetic retinopathy.
- Any clinically relevant major organ system disease including mental illnesses
- History of malignancy
- Pancreatitis
- Porphyria
- Severe disturbances of the adrenal gland
- Severe disturbances of the thyroid gland
- Allergy to vildagliptin or one of the excipients
- Allergy to metformin or one of the excipients
- Allergy to gliclazide, sulfonylurea or sulfonamides or one of the excipients.
- Drug or alcohol abuse.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
- Any other condition that could interfere with the participation in the study according to the study protocol or with the ability to cooperate and comply with the study procedures.
- Treatment with any investigational drug, within 30 days or 5 half-lives before screening, whichever is longer.
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
About this study
The purpose of this study is to explore long term glucose variability of a combination therapy of metformin and vildagliptin compared to a metformin - gliclazide combination.
Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.
- Trial with medicinal product
- Conditions
- Type 2 Diabetes
- Being tested
- Vildagliptin
- 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.
VildagliptinDrug
Vildagliptin 50mg twice/d as add-on to metformin alone over 18 months compared to an add-on therapy with gliclazide 30mg max 4x/d(metformin - gliclazide).
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean amplitude of glycemic excursion as described by Service et al. (1970) calculated from the glucose excursions of the CGMS profiles using MiniMedSolution Software (MedtronicMiniMed).
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426737
- Sponsor's protocol ID
- CLAF237ACH02T
- Status last verified
- Aug 2011
- First submitted
- 18 Apr 2011
- Last updated
- 31 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swiss Glucose Variability Study
- ClinicalTrials.gov ID
- NCT01426737
- Acronym / sponsor ID
- CLAF237ACH02T
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 31 Aug 2011 (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 explore long term glucose variability of a combination therapy of metformin and vildagliptin compared to a metformin - gliclazide combination.
Multicenter, randomized, open, parallel group, Phase IV study, of 18 months duration.
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients aged =30 -= 75 years.
- History of type 2 diabetes for at least 6 months.
- Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with HbA1c of 6.5-9.0%.
- Patients inadequately controlled (i.e. not reaching target) with maximum tolerated doses of metformin with a body mass index (BMI) of 25-40 kg/m2.
- Patients that are currently treated with metformin, gliclazide or both but not with other glucose lowering agents.
Key exclusion criteria (27 listed)
- Type 1 diabetes as defined by the American Diabetes Association (ADA).
- Type 2 diabetes currently (last 3 months) treated with insulin or glitazones.
- Acute or chronic diseases causing tissue hypoxia such as:
- Active liver disease with alanine aminotransferase (ALAT) and / or aspartate aminotransferase (ASAT) > 3 x upper limit of normal.
- Relevant kidney disease such as :
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 |
|---|---|---|
| VildagliptinVildagliptin 50mg twice/d as add-on to metformin alone over 18 months compared to an add-on therapy with gliclazide 30mg max 4x/d(metformin - gliclazide). | Drug | – |
Primary outcome
Mean amplitude of glycemic excursion as described by Service et al. (1970) calculated from the glucose excursions of the CGMS profiles using MiniMedSolution Software (MedtronicMiniMed).
Time frame: 48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
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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.
01 Studienregister MasterAdmins contact
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
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 Vildagliptin in people with Type 2 Diabetes, run by University of Zurich 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 7 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 31 Aug 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean amplitude of glycemic excursion as described by Service et al. (1970) calculated from the glucose excursions of the CGMS profiles using MiniMedSolution Software (MedtronicMiniMed). (time frame: 48h). 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 31 Aug 2011.