Type 2 Diabetes MellitusPhase 3NCT00822211
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
A Phase 3 study testing Vildagliptin 50 mg bid and Vildagliptin 50 mg qd in people with Type 2 Diabetes Mellitus, run by Novartis at 17 sites in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin 50 mg bid and Vildagliptin 50 mg qd
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 17 sitesChina
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 3
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- Agreement to maintain the same dose of metformin from randomization to the end of the study
- Age in the range of 18-78 years inclusive
- Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
- HbA1c in the range of > 7.0 to ≤10% at Visit 1
- Agreement to maintain prior diet and exercise habits during the full course of the study
- Ability to comply with all study requirements
Who cannot join
- Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
China-Japan Friendship Hospital
Beijing
General Hospital of Beijing Military Region of PLA
Beijing
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
The General Hospital of the PLA
Beijing
The General Hospital of the Second Artilleryman of PLA
Beijing
The Affiliated Union Hospital of Fujian Medical University
Fuzhou
The Fuzhou General Hospital of the PLA Nanjing Military Area
Fuzhou
Guangdong Provincial People's Hospital
Guangzhou
Second Affiliated Hospital of Nanchang University
Nanchang
The Jiangxi Provincial People's Hospital
Nanchang
Te Affiliated Drum Tower of Nanjing University Medical School
Nanjing
Tongji Hospital of Tongji University
Nanjing
Shanghai Changzheng Hospital
Shanghai
The Second Affiliated Hospital of China Medical University
Shenyang
The Second Affiliated Hospital of Tianjin Medical University
Tianjin
First Affiliated Hospital of 4th Military Medical University
Xi'an
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin 50 mg bid, Vildagliptin 50 mg qd, Placebo
- Keywords
- Diabetes Mellitus, HbA1c reduction, vildagliptin, add-on to metformin, Chinese patients
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin 50 mg bidDrug
Vildagliptin 50 mg qdDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin Dose 1 | Experimental | Not described Receives: Drug: Vildagliptin 50 mg bid |
| Vildagliptin Dose 2 | Experimental | Not described Receives: Drug: Vildagliptin 50 mg qd |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c after 24 weeks
Measured: 24 weeks
Secondary outcomes (3)
Percent of patients with HbA1c < 7% after 24 weeks
Measured: 24 weeks
Adverse event profile after 24 weeks of treatment
Measured: 24 weeks
Change from baseline in fasting plasma glucose at 24 weeks
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
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 Diabetes MellitusStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822211
- Sponsor's protocol ID
- CLAF237A23140
- Status last verified
- Nov 2016
- First submitted
- 13 Jan 2009
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Pan C, Xing X, Han P, Zheng S, Ma J, Liu J, Lv X, Lu J, Bader G; Institution Investigators. Efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Aug;14(8):737-44. doi: 10.1111/j.1463-1326.2012.01593.x. Epub 2012 Apr 1.
PubMed 22369287
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
- A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT00822211
- Acronym / sponsor ID
- CLAF237A23140
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus, HbA1c reduction, vildagliptin, add-on to metformin, Chinese patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Jan 2009 (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 assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin Dose 1 | Experimental | Drug: Vildagliptin 50 mg bid |
| Vildagliptin Dose 2 | Experimental | Drug: Vildagliptin 50 mg qd |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- Agreement to maintain the same dose of metformin from randomization to the end of the study
- Age in the range of 18-78 years inclusive
- Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
- HbA1c in the range of > 7.0 to ≤10% at Visit 1
Key exclusion criteria (3 listed)
- Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1
- Pregnant or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| Vildagliptin 50 mg bid | Drug | Vildagliptin Dose 1 |
| Vildagliptin 50 mg qd | Drug | Vildagliptin Dose 2 |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in HbA1c after 24 weeks
Time frame: 24 weeks
3 secondary outcomes
Percent of patients with HbA1c < 7% after 24 weeks
Time frame: 24 weeks
Adverse event profile after 24 weeks of treatment
Time frame: 24 weeks
Change from baseline in fasting plasma glucose at 24 weeks
Time frame: 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 22369287Pan C, Xing X, Han P, Zheng S, Ma J, Liu J, Lv X, Lu J, Bader G; Institution Investigators. Efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Aug;14(8):737-44. doi: 10.1111/j.1463-1326.2012.01593.x. Epub 2012 Apr 1.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vildagliptin 50 mg bid and Vildagliptin 50 mg qd in people with Type 2 Diabetes Mellitus, run by Novartis at 17 sites 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 7 inclusion and 3 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 17 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 HbA1c after 24 weeks (time frame: 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 NCT00822211, 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.