Diabetes Mellitus, Type 2Phase 3NCT00382096
Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin, Metformin and Vildagliptin + Metformin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes 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 Vildagliptin + Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,179 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2006to 3 Jun 2008
- 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
- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- Diagnosis of T2DM for at least 4 weeks prior to study entry
- Age 18 - 78 years inclusive
- Body mass index (BMI) of 22 - 40 kg/m2
- HbA1c: 7.5 - 11% inclusive
- FPG <270 mg/dL (15 mmol/L)
Who cannot join
- Pregnant or lactating female
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin, Metformin, Vildagliptin + Metformin
- Keywords
- Type 2 diabetes, vildagliptin, metformin, hemoglobin A1c
- 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
MetforminDrug
Vildagliptin + MetforminDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin + Metformin Dose 1 | Experimental | Not described Receives: Drug: Vildagliptin + Metformin |
| Vildagliptin + Metformin Dose 2 | Experimental | Not described Receives: Drug: Vildagliptin + Metformin |
| Vildagliptin | Active comparator | Not described Receives: Drug: Vildagliptin |
| 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.
Change from baseline in HbA1c
Measured: At week 24
Secondary outcomes (5)
Change from baseline in fasting plasma glucose
Measured: At week 24
Percent of patients with endpoint HbA1c <7%
Measured: At week 24
Percent of patients with reduction in HbA1c >/=0.7%
Measured: At week 24
Adverse event profile after treatment
Measured: At week 24
Change from baseline in body weight
Measured: At week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startSep 2006
- Primary completion3 Jun 2008
- Study completion3 Jun 2008
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
- 1,179 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
- NCT00382096
- Sponsor's protocol ID
- CLMF237A2302
- Status last verified
- May 2017
- First submitted
- 26 Sep 2006
- Last updated
- 19 Dec 2020
- Results posted
- No
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 Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00382096
- Acronym / sponsor ID
- CLMF237A2302
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, vildagliptin, metformin, hemoglobin A1c
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- 3 Jun 2008 (actual)
- Study completion
- 3 Jun 2008 (actual)
- First posted
- 28 Sep 2006 (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 evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin + Metformin Dose 1 | Experimental | Drug: Vildagliptin + Metformin |
| Vildagliptin + Metformin Dose 2 | Experimental | Drug: Vildagliptin + Metformin |
| Vildagliptin | Active comparator | Drug: Vildagliptin |
| 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 (6 listed)
- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- Diagnosis of T2DM for at least 4 weeks prior to study entry
- Age 18 - 78 years inclusive
- Body mass index (BMI) of 22 - 40 kg/m2
- HbA1c: 7.5 - 11% inclusive
Key exclusion criteria (4 listed)
- Pregnant or lactating female
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- 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 | Drug | Vildagliptin |
| Metformin | Drug | Metformin |
| Vildagliptin + Metformin | Drug | Vildagliptin + Metformin Dose 1, Vildagliptin + Metformin Dose 2 |
Primary outcome
Change from baseline in HbA1c
Time frame: At week 24
5 secondary outcomes
Change from baseline in fasting plasma glucose
Time frame: At week 24
Percent of patients with endpoint HbA1c <7%
Time frame: At week 24
Percent of patients with reduction in HbA1c >/=0.7%
Time frame: At week 24
Adverse event profile after treatment
Time frame: At week 24
Change from baseline in body weight
Time frame: At week 24
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.
- Clinical Trial Results for CLMF237A2302 at Novartis Clinical Trials.comLink provided by the sponsor.
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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
2 sites in 2 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 Vildagliptin + Metformin in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 2 sites in 2 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 4 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 2 sites in United States, Germany. 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?
Change from baseline in HbA1c (time frame: At week 24). 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.