Type 2 Diabetes MellitusPhase 3NCT01257451
Safety and Efficacy of Galvus in Elderly Type 2 Diabetes Patients
A Phase 3 study testing Vildagliptin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 46 sites in 7 countries.
Trial summary
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 431 participants
- Where
- 46 sitesin 7 countries
- Study dates
- Dec 2010to Mar 2012
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age: ≥ 70 years inclusive at Visit 1.
- patients with a confirmed diagnosis of T2DM
- HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
- body mass index (BMI) in the range of 19-45kg/m2
Who cannot join
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- previous or current participation in any vildagliptin clinical study.
- history of hypersensitivity to DPP-4 inhibitors.
- concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
46 sites in 7 countries.
46 sites in 7 countries
Germany13 sites
Novartis Investigative Site
Bamberg, 96050
Novartis Investigative Site
Beckum, 59269
Novartis Investigative Site
Berlin, 10115
Novartis Investigative Site
Eisleben Lutherstadt, 06295
Novartis Investigative Site
Falkensee, 14612
Novartis Investigative Site
Lichtenfels, 96215
Novartis Investigative Site
Magdeburg, 39112
Novartis Investigative Site
Mammendorf, 82291
Novartis Investigative Site
Münster, Germany, 48143
Novartis Investigative Site
Potsdam, 14469
Novartis Investigative Site
Sulzbach-Rosenberg, 92237
Novartis Investigative Site
Völlkingen, Germany, 66333
Novartis Investigative Site
Wetter, 58300
Belgium7 sites
Novartis Investigative Site
Buizingen, 1501
Novartis Investigative Site
De Pinte, 9840
Novartis Investigative Site
Genk, 3600
Novartis Investigative Site
Mouscron, 7700
Novartis Investigative Site
Nazareth, 9810
Novartis Investigative Site
Oostham, 3945
Novartis Investigative Site
Wichelen, Belgium, 9260
Bulgaria7 sites
Novartis Investigative Site
Blagoevgrad, Bulgaria, 2700
Novartis Investigative Site
Dimitrovgrad, Bulgaria, 6400
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, Bulgaria, 4001
Novartis Investigative Site
Sofia, Bulgaria, 1431
Novartis Investigative Site
Sofia, 1431
Novartis Investigative Site
Varna, Bulgaria, 9002
Slovakia7 sites
Novartis Investigative Site
Bratislava, Slovak Republic, 811 02
Novartis Investigative Site
Košice, 040 22
Novartis Investigative Site
Levice, Slovakia, 934 01
Novartis Investigative Site
Ľubochňa, Slovak Republic, 03491
Novartis Investigative Site
Nové Zámky, Slovakia, 940 01
Novartis Investigative Site
Pie¿¿any, Slovakia, 92101
Novartis Investigative Site
Ružomberok, 034 01
United Kingdom5 sites
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Exeter, EX2 5DW
Novartis Investigative Site
Stevenage, SG1 4AB
Novartis Investigative Site
Truro, Cornwall, TR1 3LJ
Novartis Investigative Site
Wiltshire, SN15 2SB
Spain4 sites
Novartis Investigative Site
Alicante, Alicante, 03114
Novartis Investigative Site
Alzira, Valencia, 46600
Novartis Investigative Site
Centelles, Barcelona, 08540
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540
Finland3 sites
Novartis Investigative Site
Helsinki, 00180
Novartis Investigative Site
Lahti, Suomi, 15110
Novartis Investigative Site
Oulu, FIN-90100
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)
This study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Placebo
- Keywords
- Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients
- 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
vildagliptin 50mg bid
PlaceboDrug
Placebo 50mg bid
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: Vildagliptin |
| 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.
To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
Measured: 24 weeks
Secondary outcomes (3)
To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram.
Measured: 24 weeks
To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo
Measured: 24 weeks
To assess the responder rates of patients treated with vildagliptin as compared to placebo
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 posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionMar 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals Corporation, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257451
- Sponsor's protocol ID
- CLAF237A23150
- Other IDs
- 2010-022658-18
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2010
- Last updated
- 18 Dec 2012
- Results posted
- No
Publications
Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldanius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2. Epub 2013 May 23.
PubMed 23706759
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 24 Weeks Treatment With Vildagliptin in Type 2 Diabetes Mellitus Patients ≥ 70 Years (Drug-naive or Inadequately Controlled on Oral Agents)
- ClinicalTrials.gov ID
- NCT01257451
- Acronym / sponsor ID
- CLAF237A23150
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Vildagliptin, Elderly Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Dec 2010 (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 study will evaluate the efficacy and safety of vildagliptin 50 mg bid in elderly patients with Type 2 Diabetes Mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Experimental | Drug: Vildagliptin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age: ≥ 70 years inclusive at Visit 1.
- patients with a confirmed diagnosis of T2DM
- HbA1c of ≥ 7% and ≤10.0% by central laboratory at Visit 1 and assessed by the investigator to be inadequately controlled
- body mass index (BMI) in the range of 19-45kg/m2
Key exclusion criteria (5 listed)
- FPG ≥ 270 mg/dL (≥ 15.0 mmol/L)
- previous or current participation in any vildagliptin clinical study.
- history of hypersensitivity to DPP-4 inhibitors.
- concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study.
- donation of blood or significant blood loss equaling to at least one unit of blood within the past 2 weeks of start of study or a blood transfusion within the past 12 weeks or planned regular transfusions during the study period 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 |
|---|---|---|
| Vildagliptinvildagliptin 50mg bid | Drug | Vildagliptin |
| PlaceboPlacebo 50mg bid | Drug | Placebo |
Primary outcome
To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo
Time frame: 24 weeks
3 secondary outcomes
To evaluate the safety and tolerability of vildagliptin in elderly patients with T2DM who are drug-naive or inadequately controlled with oral antidiabetic drugs (OADs) including physical exam, vital sign, hematology, chemistry and electrocardiogram.
Time frame: 24 weeks
To evaluate the proportion of vildagliptin treated patients achieving fasting plasma glucose (FPG) reduction relative to placebo
Time frame: 24 weeks
To assess the responder rates of patients treated with vildagliptin as compared to placebo
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 Dec 2012.
- Derived from this study: PubMed 23706759Strain WD, Lukashevich V, Kothny W, Hoellinger MJ, Paldanius PM. Individualised treatment targets for elderly patients with type 2 diabetes using vildagliptin add-on or lone therapy (INTERVAL): a 24 week, randomised, double-blind, placebo-controlled study. Lancet. 2013 Aug 3;382(9890):409-416. doi: 10.1016/S0140-6736(13)60995-2. Epub 2013 May 23.
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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
Novartis Pharmaceuticals Corporation study director
Novartis Pharmaceuticals
46 sites in 7 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 46 sites in 7 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 4 inclusion and 5 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 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Germany, Belgium, Bulgaria, Slovakia, United Kingdom and 2 more countries. 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?
To evaluate the proportion of vildagliptin treated patients achieving HbA1c reduction and/or proportion reaching investigator defined target HbA1c relative to placebo (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 NCT01257451, 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 Dec 2012.