Diabetes Mellitus, Type 2Phase 3NCT01497522
Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 20 sites in Japan.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus… 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 183 participants
- Where
- 20 sitesJapan
- Study dates
- Dec 2011to Feb 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range 20-35 kg/m2
Who cannot join
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Japan20 sites
Novartis Investigative Site
Ageo, Saitama, 362-8588
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-0031
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0084
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0001
Novartis Investigative Site
Fukuoka, Fukuoka, 819-0168
Novartis Investigative Site
Hachiōji, Tokyo, 192-0046
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0014
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0296
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Kurume, Fukuoka, 830-8543
Novartis Investigative Site
Kyoto, Kyoto, 607-8062
Novartis Investigative Site
Kyoto, Kyoto, 615-0035
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075
Novartis Investigative Site
Nerima-ku, Tokyo, 177-0051
Novartis Investigative Site
Ohkawa-city, Fukuoka, 831-0016
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032
Novartis Investigative Site
Takatsuki, Osaka, 569-1096
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021
Novartis Investigative Site
Yokohama, Kanagawa, 221-0802
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin, Placebo
- Keywords
- Vildagliptin, Type 2 diabetes, HbA1c, Fasting plasma glucose
- 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
vildagliptin 50 mg twice daily
PlaceboDrug
Matching Placebo of vildagliptin 50 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | In addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily. Receives: Drug: Vildagliptin |
| Placebo | Placebo comparator | In addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups
HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
Measured: Baseline to 12 weeks
Secondary outcomes (4)
Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses
HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
Measured: Baseline to 12 weeks
Change from baseline in Fasting plasma glucose (FPG) at 12 weeks
FPG will be performed on a blood sample obtained by study personnel and analyzed at a central laboratory.
Measured: Baseline to 12 weeks
Percentage of patients meeting Responder rates in HbA1c
Responder rates will be categorized by predefined HbA1c value at 12 weeks :
- Endpoint HbA1c ≤ 6.5%
- Endpoint HbA1c ≤ 7%
- Endpoint HbA1c ≤ 7% in patients with baseline HbA1c ≤ 8%
Measured: 12 weeks
Number of patients with adverse events (including hypoglycemia), serious adverse events and death
The occurrence of adverse events will be sought by non-directive questioning of the patient at each visit. Adverse events are defined as appearance or worsening of any undesirable symptom, sign (including an abnormal laboratory finding), or medical conditions. 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: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionFeb 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 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 3
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 183 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
- NCT01497522
- Sponsor's protocol ID
- CLMF237A1301
- Status last verified
- Feb 2017
- First submitted
- 20 Dec 2011
- Last updated
- 27 Feb 2017
- Results posted
- No
Publications
Odawara M, Hamada I, Suzuki M. Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. Epub 2014 Mar 7.
PubMed 24604395
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. 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 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT01497522
- Acronym / sponsor ID
- CLMF237A1301
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Vildagliptin, Type 2 diabetes, HbA1c, Fasting plasma glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 22 Dec 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 the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: VildagliptinIn addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily. |
| Placebo | Placebo comparator | Drug: PlaceboIn addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range 20-35 kg/m2
Key exclusion criteria (3 listed)
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
- 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 |
|---|---|---|
| VildagliptinAlso: LAF237vildagliptin 50 mg twice daily | Drug | Vildagliptin |
| PlaceboMatching Placebo of vildagliptin 50 mg twice daily | Drug | Placebo |
Primary outcome
Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups
Time frame: Baseline to 12 weeks
HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
4 secondary outcomes
Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses
Time frame: Baseline to 12 weeks
Change from baseline in Fasting plasma glucose (FPG) at 12 weeks
Time frame: Baseline to 12 weeks
Percentage of patients meeting Responder rates in HbA1c
Time frame: 12 weeks
Number of patients with adverse events (including hypoglycemia), serious adverse events and death
Time frame: 12 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 27 Feb 2017.
- Results publication: PubMed 24604395Odawara M, Hamada I, Suzuki M. Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. Epub 2014 Mar 7.
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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
20 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 in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 20 sites in Japan.
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 3 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 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Japan. 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 glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups (time frame: Baseline to 12 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 NCT01497522, 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 27 Feb 2017.