Type 2 DiabetesPhase 4NCT01541956
Efficacy of VIldagliptin aS an Add-on Therapy to Metformin Compared to Metformin Up-TitratION in Chinese Patients With Type 2 Diabetes.(VISION)
A Phase 4 study testing Metformin and vildagliptin in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Metformin and vildagliptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,091 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese T2D patients who are inadequate controlled (6.5 %< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),
Who cannot join
- Type 1 diabetes and secondary diabetes
- Acute metabolic diabetic complications within the past 3 months.
- Acute infections which may influence glucose level.
- Evidence of significant chronic diabetic complications,
- Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
- FPG > 270 mg/dl (15 mmol/l)
- Any of the following disease within the past 6 months: myocardial infarction (MI); coronary artery bypass surgery or percutaneous coronary intervention; unstable angina or stroke; Congestive heart failure (CHF)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy .
This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.
- Conditions
- Type 2 Diabetes
- Being tested
- Metformin, vildagliptin
- Keywords
- type 2 diabetes;, vildagliptin;, metformin;
- 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
500 mg twice daily
vildagliptinDrug
Also called LAF237
Vildagliptin 50 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| metformin up titration | Active comparator | metformin 500 mg bid will be up titrated (total daily dose up to 2000 mg) Receives: Drug: Metformin |
| vildagliptin add on to metformin | Experimental | Vildagliptin 50 mg twice daily + Metformin 500mg twice daily Receives: Drug: Metformin; Drug: vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks
Measured: baseline, 24 weeks
Secondary outcomes (6)
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups
The changes from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment will be analyzed in pre-defined patient subgroups based on Body Mass Index(BMI) ( <24, ≥ 24) and age (<60 y and ≥ 60 y)
Measured: baseline and 24 weeks
Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%
The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% of two treatment arms in the overall population and in pre defined sub groups.
Measured: baseline and 24 weeks
Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events
The percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5% without adverse GI events of two treatment arms in the overall population and in pre defined sub groups.
Measured: baseline and 24 weeks
Mean change from baseline in fasting plasma glucose (FPG)
Mean change from baseline in FPG will be calculated in the overall population and in pre defined sub groups.
Measured: baseline, 24 weeks
Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample
Mean change from baseline in 2 hour post prandial glucose(PPG) in a sub sample of overall patients.
Measured: baseline, 24 weeks
Number of patients with adverse events, serious adverse events and death
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 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 Type 2 DiabetesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,091 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
- NCT01541956
- Sponsor's protocol ID
- CLAF237ACN01
- Status last verified
- Nov 2016
- First submitted
- 24 Feb 2012
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ji LN, Pan CY, Lu JM, Li H, Zhu DL, Li Q, Li QF, Peng YD, Tian HM, Yao C, Zhao ZG, Wang L, Wang BH; VISION Study Group. Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION). Diabetes Obes Metab. 2016 Aug;18(8):775-82. doi: 10.1111/dom.12667. Epub 2016 May 18.
PubMed 27406394
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled, Randomized, Multicenter, Prospective, Parallel Group, Interventional Study to Demonstrate the Effectiveness of 24 Weeks Treatment With Vildagliptin 50mg Bid as Add on to Metformin 500 mg Bid Compared to Metformin up to 1000 mg Bid in Chinese Patients With Type 2 Diabetes Inadequately Controlled on Metformin 500 mg Bid Monotherapy .
- ClinicalTrials.gov ID
- NCT01541956
- Acronym / sponsor ID
- CLAF237ACN01
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes;, vildagliptin;, metformin;
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,091 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 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.
This is an open-labeled, randomized, multicenter, prospective, parallel group, interventional study to demonstrate the effectiveness of 24 weeks treatment with Vildagliptin 50mg bid as add on to metformin 500 mg bid compared to metformin up to 1000 mg bid in Chinese patients with type 2 diabetes inadequately controlled on sub maximal dosage metformin monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin up titration | Active comparator | Drug: Metforminmetformin 500 mg bid will be up titrated (total daily dose up to 2000 mg) |
| vildagliptin add on to metformin | Experimental | Drug: Metformin, Drug: vildagliptinVildagliptin 50 mg twice daily + Metformin 500mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chinese T2D patients who are inadequate controlled (6.5 %< HbA1C ≤9%) by metformin (≥750mg/d but ≤1000mg/d, ≥12 weeks),
Key exclusion criteria (8 listed)
- Type 1 diabetes and secondary diabetes
- Acute metabolic diabetic complications within the past 3 months.
- Acute infections which may influence glucose level.
- Evidence of significant chronic diabetic complications,
- Clinically significant renal impairment and hepatic impairment patients, including history of cirrhosis or chronic hepatitis,
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 |
|---|---|---|
| Metformin500 mg twice daily | Drug | metformin up titration, vildagliptin add on to metformin |
| vildagliptinAlso: LAF237Vildagliptin 50 mg twice daily | Drug | vildagliptin add on to metformin |
Primary outcome
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin
Time frame: baseline, 24 weeks
The change from baseline in hemoglobin A1c(HbA1c) after 24 weeks treatment in vildagliptin 50 mg bid used in combination with metformin 500 mg bid is not inferior to that with metformin up to 1000 mg bid as monotherapy after 24 weeks
6 secondary outcomes
Change from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment in pre-defined patient subgroups
Time frame: baseline and 24 weeks
Percentage of patients achieving target hemoglobin A1c( HbA1C) of ≤6.5%
Time frame: baseline and 24 weeks
Percentage of patients achieving target hemoglobin A1c(HbA1C) of ≤6.5% without adverse gastrointestinal (GI) events
Time frame: baseline and 24 weeks
Mean change from baseline in fasting plasma glucose (FPG)
Time frame: baseline, 24 weeks
Mean change from baseline in 2-hour post prandial glucose( PPG) in a sub sample
Time frame: baseline, 24 weeks
Number of patients with adverse events, serious adverse events and death
Time frame: up to 24 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 18 Nov 2016.
- Results publication: PubMed 27406394Ji LN, Pan CY, Lu JM, Li H, Zhu DL, Li Q, Li QF, Peng YD, Tian HM, Yao C, Zhao ZG, Wang L, Wang BH; VISION Study Group. Efficacy and safety of combination therapy with vildagliptin and metformin versus metformin uptitration in Chinese patients with type 2 diabetes inadequately controlled with metformin monotherapy: a randomized, open-label, prospective study (VISION). Diabetes Obes Metab. 2016 Aug;18(8):775-82. doi: 10.1111/dom.12667. Epub 2016 May 18.
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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 Metformin and vildagliptin in people with Type 2 Diabetes, run by Novartis Pharmaceuticals at 1 site in China.
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 1 inclusion and 8 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 18 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 China. 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?
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 from baseline in hemoglobin A1c(HbA1C) after 24 weeks of treatment with vildagliptin (time frame: baseline, 24 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 NCT01541956, 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 18 Nov 2016.