Type 2 Diabetes MellitusPhase 3NCT01582230
Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
A Phase 3 study testing Vildagliptin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 21 sites in 4 countries.
Trial summary
The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Apr 2012to May 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
- C-peptide >0.6 ng/ml (>0.20 nmol/L).
- HbA1c ≥7.5 to ≤11% at Visit 1
- Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
- Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
- Body Mass Index (BMI) ≥20 to ≤40 kg/m2 at Visit
Who cannot join
- Patients fulfilling any of the following criteria are not eligible for participation in the study
- Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
- Pregnant or lactating women
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Current diagnosis of congestive heart failure (NYHA III or IV).
- Myocardial infarction (MI) within the past 6 months
- Liver disease such as cirrhosis or chronic active hepatitis
- Other protocol defined inclusion/excusion criteria may apply
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
China13 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Changsha, Hunan, 410011
Novartis Investigative Site
Chengdu, Sichuan, 610072
Novartis Investigative Site
Jinan, Shandong, 250031
Novartis Investigative Site
Nanchang, Jiangxi, 330006
Novartis Investigative Site
Nanjing, Jiangsu, 210006
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Tianjin, 300052
Novartis Investigative Site
Wuxi, Jiangsu, 214023
Novartis Investigative Site
Xi’an, Shanxi, 710032
Philippines3 sites
Novartis Investigative Site
Metro Manila, 1500
Novartis Investigative Site
Pasay, Philippines, 1300
Novartis Investigative Site
Quezon City, 1102
Thailand3 sites
Novartis Investigative Site
Bangkok, Bangkok, 10330
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Khon Kaen, 40002
Singapore2 sites
Novartis Investigative Site
Singapore, Singapore, 768825
Novartis Investigative Site
Singapore, 169608
About this study
Official title: A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Placebo
- Keywords
- Type 2 diabetes mellitus, 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 Galvus, LAF237
Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks
PlaceboDrug
Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Eligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. Receives: Drug: Vildagliptin |
| Placebo | Placebo comparator | Eligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. 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 study endpoint, assessed in overall study population
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
Measured: Baseline and every study visit up to 24 weeks
Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
Measured: Baseline and every study visit up to 24 weeks
Secondary outcomes (6)
Number of patients with adverse events, serious adverse events and death on over all population
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: 24 weeks
Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population
FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.
Measured: Baseline, week 24
Percentage of patients meeting responder criteria after 24 weeks treatment on overall population
Responder rate will be analyzed in the following categories:
- Endpoint HbA1c ≤ 6.5%
- Endpoint HbA1c < 7%
- Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed
Measured: After 24 weeks
Number of patients with adverse events, serious adverse events and death on Chinese population
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: 24 weeks
Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population
FPG will be performed on the blood samples collected at all every study visits from baseline to week 24.
Measured: Baseline, week 24
Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population
Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c < 7% • Endpoint HbA1c <7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed
Measured: After 24 weeks
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 2012
- Primary completionMay 2013
- Study completionMay 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 Diabetes MellitusStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 293 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
- NCT01582230
- Sponsor's protocol ID
- CLAF237A23155
- Status last verified
- Aug 2013
- First submitted
- 18 Apr 2012
- Last updated
- 30 Aug 2013
- Results posted
- No
Publications
Ning G, Wang W, Li L, Ma J, Lv X, Yang M, Wang W, Woloschak M, Lukashevich V, Kothny W. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303.
PubMed 25929739
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Vildagliptin 50mg Bid as an add-on Therapy to Insulin, With or Without Metformin, in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01582230
- Acronym / sponsor ID
- CLAF237A23155
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Apr 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 purpose of this study is to assess the efficacy and safety of vildagliptin 50mg bid add-on therapy to improve overall glycemic control in patients with type 2 diabetes mellitus inadequately controlled on insulin with or without metformin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: VildagliptinEligible patients will receive vildagliptin 50 mg in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboEligible patients will receive matching placebo in addition to their stable dose of insulin with or without metformin. One tablet should be taken twice daily as one tablet before breakfast meal and one tablet before the evening meal for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with confirmed diagnosis of Type2 diabetes mellitus (T2DM) by standard criteria
- C-peptide >0.6 ng/ml (>0.20 nmol/L).
- HbA1c ≥7.5 to ≤11% at Visit 1
- Treatment with stable, once or twice daily doses (maximum dose of < 1 unit/kg/day) of basal (long-acting, intermediate-acting) insulin alone or pre-mixed insulin for at least 12 weeks prior to Visit 1. Stable is defined as ±10% of the Visit 1 dose during the previous 12 weeks
- Patients receiving metformin must be on a stable dose of metformin (at least 1500 mg daily or a maximally tolerated dose) for at least 12 weeks prior to Visit 1
Key exclusion criteria (8 listed)
- Patients fulfilling any of the following criteria are not eligible for participation in the study
- Fasting plasma glucose (FPG) ≥240 mg/dl (13.3 mmol/L) at Visit 1
- Pregnant or lactating women
- Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months
- Current diagnosis of congestive heart failure (NYHA III or IV).
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: Galvus, LAF237Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks | Drug | Vildagliptin |
| PlaceboPatient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks | Drug | Placebo |
Primary outcome
Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population
Time frame: Baseline and every study visit up to 24 weeks
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population
Time frame: Baseline and every study visit up to 24 weeks
HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive.
6 secondary outcomes
Number of patients with adverse events, serious adverse events and death on over all population
Time frame: 24 weeks
Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population
Time frame: Baseline, week 24
Percentage of patients meeting responder criteria after 24 weeks treatment on overall population
Time frame: After 24 weeks
Number of patients with adverse events, serious adverse events and death on Chinese population
Time frame: 24 weeks
Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population
Time frame: Baseline, week 24
Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population
Time frame: After 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 30 Aug 2013.
- Derived from this study: PubMed 25929739Ning G, Wang W, Li L, Ma J, Lv X, Yang M, Wang W, Woloschak M, Lukashevich V, Kothny W. Vildagliptin as add-on therapy to insulin improves glycemic control without increasing risk of hypoglycemia in Asian, predominantly Chinese, patients with type 2 diabetes mellitus. J Diabetes. 2016 May;8(3):345-53. doi: 10.1111/1753-0407.12303.
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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
21 sites in 4 countries: 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 Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 21 sites in 4 countries.
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 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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China, Philippines, Thailand, Singapore. 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 study endpoint, assessed in overall study population (time frame: Baseline and every study visit up to 24 weeks). The study lists 2 primary outcomes in all. 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 NCT01582230, 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 30 Aug 2013.