Diabetes Mellitus, Type 2Phase 4NCT01582243
Safety and Efficacy of Vildagliptin Plus Metformin (SPC) Treatment in Type 2 Diabetes Mellitus Patients
A Phase 4 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 1 site in Taiwan.
Trial summary
This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2013to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients who were 20 years of age and older with diagnosis of T2DM.
- Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
- Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
- Understood the nature of the study, and had signed informed consent form.
Who cannot join
- Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
- Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1.
- Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1.
- Female patients who needed to lactate during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients
This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin
- Keywords
- Diabetes Mellitus, type 2, 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
Also called LAF237, Galvus Met
Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin plus metformin (SPC) | Experimental | Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
HbA1c analysis will be performed on a blood sample obtained by study personnel.
Measured: Baseline, Week 24
Secondary outcomes (5)
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
HbA1c analysis will be performed on a blood sample obtained by study personnel.
Measured: Baseline, week 12
Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24
FPG analysis will be performed on a blood sample obtained by study personnel.
Measured: Baseline, week 12, week 24
Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24
PPG analysis will be performed on a blood sample obtained by study personnel.
Measured: Baseline, week, week 24
Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week
Mean amplitude of glycemic excursions (MAGE), which was used to quantify major swings of glycaemia and assess intra-day glycemic variability, was measured by inserting continuous glucose monitoring system (CGMS) in patients for 72 consecutive hours before Day 1 (Visit 2) and Week 24 (Visit 5). In order to unify the different initial time and time of completion in each patient, only the data recorded from Day 2 00:00 to Day 3 23:59 with total 48 hours were analyzed.
Measured: Baseline, week 24
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
Patients reaching glycemic goal of HbA1c ≤ 6.5% and ≤ 7.0% at week 12 and 24 will be calculated respectively.
Measured: week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startApr 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582243
- Sponsor's protocol ID
- CLAF237ATW03
- Status last verified
- Sep 2016
- First submitted
- 18 Apr 2012
- Last updated
- 3 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Interventional Study to Assess the HbA1c Change an 24-hr Glucose Fluctuation After Vildagliptin Plus Metformain (SPC) Treatment in Metformin Monotherapy Uncontrolled Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT01582243
- Acronym / sponsor ID
- CLAF237ATW03
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, type 2, vildagliptin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 3 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy of vildagliptin plus metformin (SPC) treatment in type 2 diabetes mellitus patients uncontrolled by metformin monotherapy after 24 weeks treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin plus metformin (SPC) | Experimental | Drug: VildagliptinEligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients who were 20 years of age and older with diagnosis of T2DM.
- Patients who had been treated with stable dose of metformin (≥1000 mg/day) monotherapy at least 4 weeks prior to Visit 1 and had failed to achieve the glucose control goal. The glucose control goal was defined as HbA1c ≤ 6.5%.
- Male or female with child-bearing potential agreed to use an effective method of contraception approved by the investigator during the study.
- Understood the nature of the study, and had signed informed consent form.
Key exclusion criteria (4 listed)
- Patients with contraindications mentioned in the Summary of Product Characteristics for vildagliptin or metformin.
- Patients with renal dysfunction defined as creatinine clearance < 60 ml/min at Visit 1.
- Patients with history of hepatic impairment, including but not limited to those with pretreatment AST or ALT > 3 ULN at Visit 1.
- Female patients who needed to lactate during the study.
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 |
|---|---|---|
| VildagliptinAlso: LAF237, Galvus MetVildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC) | Drug | Vildagliptin plus metformin (SPC) |
Primary outcome
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time frame: Baseline, Week 24
HbA1c analysis will be performed on a blood sample obtained by study personnel.
5 secondary outcomes
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Time frame: Baseline, week 12
Mean Change From Baseline in Fasting Plasma Glucose(FPG) at Week 12 and 24
Time frame: Baseline, week 12, week 24
Mean Change From Baseline in Postprandial Plasma Glucose(PPG) at Week 12 and 24
Time frame: Baseline, week, week 24
Mean Change From Baseline in Mean Amplitude of Glycemic Excursions (MAGE) Detected by Continuous Glucose Monitoring System (CGMS) After 24-week
Time frame: Baseline, week 24
The Percentage of Patients Achieving the Two Glycemic Goals After 12- and 24-week Treatment
Time frame: week 12, week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 1 site in Taiwan.
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 4 inclusion and 4 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 3 Nov 2016. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline, Week 24). 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 3 Nov 2016.