Diabetes Mellitus, Type 2Phase 3NCT00728351
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)
A Phase 3 study testing vildagliptin + metformin and metformin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 63 sites in 5 countries.
Trial summary
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- vildagliptin + metformin and metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 63 sitesin 5 countries
- Study dates
- Jun 2008to Feb 2010
- 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
- History of T2DM treated with Metformin
Who cannot join
- FPG >= 260 mg/dL (14.4mmol/L)
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
63 sites in 5 countries.
63 sites in 5 countries
United States16 sites
Study site
Bangor, Maine, 04401
Study site
Billings, Montana, 59102
Study site
Denver, Colorado, 80209
Study site
Houston, Texas, 77023
Study site
Houston, Texas, 77074
Study site
Houston, Texas, 77081
Study site
Long Beach, California, 90806
Novartis Investigative Site
New Brunswick, New Jersey, 08903
Study site
Norfolk, Virginia, 23510
Study site
Oklahoma City, Oklahoma, 73104
Study site
Pine Bluff, Arkansas, 71603
Study site
Taylors, South Carolina, 29687
Study site
Trenton, New Jersey, 08611
Study site
Uniontown, Pennsylvania
Study site
Wenatchee, Washington, 98801
Study site
Wilmington, North Carolina, 28409
Germany16 sites
Hausärztliche Praxis
Aschaffenburg, 63739
Klinische Forschung Berlin Mitte GmbH
Berlin, 10117
AVK
Berlin, 12157
Gemeinschaftspraxis
Celle, 29221
Malteser KM
Duisburg, 42259
Untertrintroper Hausarztzentrum
Essen, 45359
Study site
Gefrees, 95482
Diabeteszentrum Billstedt/Horn
Hamburg, 22119
Diabetologische Schwerpunktpraxis
Hamburg, 22119
St. Elisabeth Krankenhaus Leipzig
Leipzig, 04229
Diabetes-Schwerpunktpraxis Studienambulanz
Leipzig, 04257
Institut für Diabetes-forschung Münster
Münster, 48145
Praxis Dr. Alawi
Saarlouis, 66740
DDT
Siegen, 57072
Diabetologische Schwerpunktpraxis
Sinsheim, 74889
Praxis
Wangen, 88239
Poland16 sites
NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
Bialystok, 15-435
Gdanska Poradnia Cukrzycowa
Gdansk, 80-858
Gabinet Kardiologiczny Mediplus
Gdynia, 81-423
NZOZ "Esculap" S.C.
Gniewkowo, 88-140
SZPZOZ Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki, 05-825
NZOZ Terapia Optima
Katowice, 40-752
Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
Łęczyca, 99-100
Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
Łęczyca, 99-100
Instytut Cantrum Zdrowia Matki Polki
Lodz, 93-338
NZOZ Special-Med
Lublin, 20-044
Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
Poznan, 60-569
Lecznica Prosen-SMO NZOZ
Warsaw, 01-231
Centrum Leczenia Chorob Cywilizacyjnych
Warsaw, 02-777
NZCZ Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, 50-367
Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM
Zabrze, 41-800
Hungary12 sites
Europ-Med Orvosi Szolgaltato Kft
Budaörs, 2040
Synexus Magyarorszag
Budapest, 1036
Uzsoki Hospital
Budapest, 1145
Study site
Budapest
Kenezy Hospital
Debrecen
Gyngyosi Korhaz Kft
Gyöngyös, 3200
Petz Aladar County
Győr, 9024
Selye Janos Korhaz es Rendelointezet
Komárom, 2900
DIAPED Kft., MRC
Meggyesalja U., 122
Josa Andras Teaching Hospital
Nyíregyháza, 4400
Vas Megyei Markuscvszky Lajos Korhaz
Szombathely, 9700
Zala County Hospital
Zalaegerszeg
France3 sites
Cabinet d'Endocrinologie-Maladies Métaboliques
Annecy, 74000
Service Endocrinologic & Metabolisme
Paris, 75013
Polycliniques des minguettes
Vénissieux, 69200
About this study
Official title: A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin + metformin, metformin
- Keywords
- Type 2 diabetes, 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.
vildagliptin + metforminDrug
metforminDrug
1000 bid metformin
| Study group | Role | What they receive |
|---|---|---|
| vildagliptin + metformin | Experimental | Not described Receives: Drug: vildagliptin + metformin |
| metformin | Active comparator | Not described Receives: Drug: metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Measured: 24 weeks
Secondary outcomes (4)
FPG reduction
Measured: 24 weeks
Safety and tolerability
Measured: 24 weeks
Body weight change from baseline
Measured: 24 weeks
Changes in the fasting lipid profile
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 posted5 Aug 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 317 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
- NCT00728351
- Sponsor's protocol ID
- CLMF237A2309
- Status last verified
- Jan 2013
- First submitted
- 31 Jul 2008
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.
- ClinicalTrials.gov ID
- NCT00728351
- Acronym / sponsor ID
- CLMF237A2309
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2010 (actual)
- First posted
- 5 Aug 2008 (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 present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vildagliptin + metformin | Experimental | Drug: vildagliptin + metformin |
| metformin | Active comparator | Drug: metformin |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of T2DM treated with Metformin
Key exclusion criteria (2 listed)
- FPG >= 260 mg/dL (14.4mmol/L)
- 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 + metformin | Drug | vildagliptin + metformin |
| metformin1000 bid metformin | Drug | metformin |
Primary outcome
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Time frame: 24 weeks
4 secondary outcomes
FPG reduction
Time frame: 24 weeks
Safety and tolerability
Time frame: 24 weeks
Body weight change from baseline
Time frame: 24 weeks
Changes in the fasting lipid profile
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 19 Dec 2020.
- Click here for more information on the clinical studyLink provided by the sponsor.
- Results for CLMF237A2309 from the Novartis Clinical Trials websiteLink provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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
63 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vildagliptin + metformin and metformin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 63 sites in 5 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 1 inclusion and 2 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Germany, Poland, Hungary, France. 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 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?
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2020.