Diabetes Mellitus Type IIPhase 4NCT01565096
Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
A Phase 4 study testing Metformin, Vildagliptin and Glimepiride in people with Diabetes Mellitus Type II, run by ikfe-CRO GmbH at 1 site in Germany.
Trial summary
The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes Mellitus Type II
- What is being tested?
- Metformin, Vildagliptin and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to Nov 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 2
- HbA1c > 6.5%* ≤ 9.5%
- NOTE: Patients with cardiovascular preconditions (Coronary Heart Disease or Myocard Infarction) require an HbA1c > 7.0% ≤ 9.5%
- Treatment with Metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication for treatment with an additional medication as judged by the investigator
- Age 30 - 80 years
- Patient consents that his/her family physician will be informed of trial participation
Who cannot join
- Pre-treatment with insulin, peroxisome proliferator activated receptor (PPAR) gamma agonists or other oral antidiabetic treatments (except Metformin) within the last three months
- History of type-1-diabetes
- Fasting blood glucose >240mg/dl
- Uncontrolled hypertension (systolic blood pressure >160 and/or diastolic blood pressure >90)
- Anamnestic history of acute infections
- Anamnestic history of epilepsy
Show all 27Show fewer
- Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures
- History of severe or multiple allergies
- Hereditary galactose intolerance, lapp-lactase defect or glucose-galactose mal-absorption
- Treatment with any other investigational drug within 3 months before trial entry
- Pregnant or lactating women
- Sexually active woman of childbearing age not practicing a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices, sexual abstinence or vasectomized partner
- Progressive fatal disease
- History of drug or alcohol abuse in the past 2 years
- State after kidney transplantation
- Serum potassium > 5.5 mmol/L
- Acute myocardial infarction, open heart surgery or cerebral event (stroke/transient ischemic attack) within the previous 6 months
- Any elective surgery during study participation
- Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit
- History of pancreatitis
- Anamnestic history of dehydration, diabetic precoma or diabetic ketoacidosis
- Acute or scheduled investigation with iodine containing radiopaque material
- Uncontrolled unstable angina pectoris
- Anamnestic history of pericarditis, myocarditis, endocarditis, hemodynamic relevant aortic stenosis, aortic aneurysm or heart insufficiency NYHA III or IV
- Anamnestic recent pulmonary embolism
- History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (GFR < 60 ml), neurological, psychiatric and/or hematological disease as judged by the investigator
- Lack of compliance or other similar reason that, according to investigator, precludes satisfactory participation in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
ikfe GmbH
Mainz, 55116
Thomas Forst, Prof., MD, +49 6131 576 36 16, thomasf@ikfe.de
Swantje Anders, +49 6131 327 90 22, s.anders@ikfe-cro.de
About this study
The aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy.
- Conditions
- Diabetes Mellitus Type II
- Being tested
- Metformin, Vildagliptin, Glimepiride
- 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.
MetforminDrug
Metformin 1000 mg BID
MetforminDrug
Metformin 1000 mg BID
VildagliptinDrug
Vildagliptin 50 mg twice daily
GlimepirideDrug
Glimepiride at individual dose
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin plus Metformin | Experimental | Metformin (1000 mg BID) + Vildagliptin 50 mg twice daily Receives: Drug: Metformin; Drug: Vildagliptin |
| Glimepirid plus Metformin | Active comparator | Metformin (1000 mg BID) + Glimepiride (individual dosage) Receives: Drug: Metformin; Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min)
Measured: One year
Secondary outcomes (13)
Fasting intact proinsulin levels
Measured: One year
Max postprandial intact proinsulin levels
Measured: One year
Retinal endothelial response to flicker light stimulation
Measured: One year
Mean 24h systolic and diastolic blood pressure
Measured: One year
Erythrocyte deformability
Measured: One year
E-selectin
Measured: One year
Change in body weight
Measured: One year
hsCRP
Measured: One year
HbA1c
Measured: One year
Fasting blood glucose
Measured: One year
Number of hypoglycemic events
Measured: One year
Adverse events
Measured: One year
Drug related adverse events
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type IIStudies 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ikfe-CRO GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals, IKFE Institute for Clinical Research and Development
- Responsible party
- Sponsor
- Investigators
- Thomas Forst, Prof. Dr., Principal investigator, Ikfe GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565096
- Sponsor's protocol ID
- ikfe-Vilda-001
- Other IDs
- 2011-004286-32, CLAF237ADE06T
- Status last verified
- Mar 2012
- First submitted
- 23 Mar 2012
- Last updated
- 28 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Vildagliptin on Beta Cell Function and Cardiovascular Risk Markers in Patients With Moderate Metabolic Control During Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT01565096
- Acronym / sponsor ID
- ikfe-Vilda-001
- Conditions
- Diabetes Mellitus Type II
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- ikfe-CRO GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Pharmaceuticals, IKFE Institute for Clinical Research and Development
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (estimated)
- First posted
- 28 Mar 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 aim of this pilot-study is to investigate the effect of Vildagliptin in comparison to glimepiride on beta cell function and the cardiovascular risk profile in patients previously treated with Metformin monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin plus Metformin | Experimental | Drug: Metformin, Drug: VildagliptinMetformin (1000 mg BID) + Vildagliptin 50 mg twice daily |
| Glimepirid plus Metformin | Active comparator | Drug: Metformin, Drug: GlimepirideMetformin (1000 mg BID) + Glimepiride (individual dosage) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus type 2
- HbA1c > 6.5%* ≤ 9.5%
- Treatment with Metformin at maximal or maximal tolerated dosage, stable for at least 3 months with indication for treatment with an additional medication as judged by the investigator
- Age 30 - 80 years
- Patient consents that his/her family physician will be informed of trial participation
Key exclusion criteria (27 listed)
- Pre-treatment with insulin, peroxisome proliferator activated receptor (PPAR) gamma agonists or other oral antidiabetic treatments (except Metformin) within the last three months
- History of type-1-diabetes
- Fasting blood glucose >240mg/dl
- Uncontrolled hypertension (systolic blood pressure >160 and/or diastolic blood pressure >90)
- Anamnestic history of acute infections
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 |
|---|---|---|
| MetforminMetformin 1000 mg BID | Drug | Vildagliptin plus Metformin |
| MetforminMetformin 1000 mg BID | Drug | Glimepirid plus Metformin |
| VildagliptinVildagliptin 50 mg twice daily | Drug | Vildagliptin plus Metformin |
| GlimepirideGlimepiride at individual dose | Drug | Glimepirid plus Metformin |
Primary outcome
Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min)
Time frame: One year
13 secondary outcomes
Fasting intact proinsulin levels
Time frame: One year
Max postprandial intact proinsulin levels
Time frame: One year
Retinal endothelial response to flicker light stimulation
Time frame: One year
Mean 24h systolic and diastolic blood pressure
Time frame: One year
Erythrocyte deformability
Time frame: One year
E-selectin
Time frame: One year
Change in body weight
Time frame: One year
hsCRP
Time frame: One year
HbA1c
Time frame: One year
Fasting blood glucose
Time frame: One year
Number of hypoglycemic events
Time frame: One year
Adverse events
Time frame: One year
Drug related adverse events
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2012.
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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.
Thomas Forst, Prof. Dr. principal investigator
Ikfe GmbH
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 Metformin, Vildagliptin and Glimepiride in people with Diabetes Mellitus Type II, run by ikfe-CRO GmbH at 1 site in Germany.
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 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 28 Mar 2012. 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 Germany. 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 Thomas Forst, Prof. Dr. (+49 6131 576 36 16, thomasf@ikfe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial increase in intact proinsulin levels in patient treated with Vildagliptin and Metformin compared to intact proinsulin levels in patients treated with Glimepiride and Metformin (Area under the curve 0-300 min) (time frame: One year). 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 28 Mar 2012.