Diabetes Mellitus, Type 2Phase 3NCT00468039
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
A Phase 3 study testing vildagliptin + metformin in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in United States.
Trial summary
This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2007to 6 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 type 2 diabetes for at least 4 weeks prior to study entry
- Body mass index 22-40 kg/meter squared
- HbA1c > 11% and/or FPG >270 mg/dL
Who cannot join
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, 78229
About this study
Official title: A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control
This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin + metformin
- Keywords
- metformin, vildagliptin, initial combination
- 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
| Study group | Role | What they receive |
|---|---|---|
| vildagliptin + metformin | Experimental | Not described Receives: Drug: vildagliptin + metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycosylated hemoglobin (HbA1c)at Baseline and week 24
Measured: 24 weeks
Secondary outcomes (5)
HbA1c at Baseline and week 12
Measured: 12 weeks
Fasting plasma glucose test (FPG) at Baseline and week 24
Measured: 24 weeks
Weight at baseline and week 24
Measured: 24 weeks
Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks
Measured: 24 weeks
Safety assessed by monitoring and recording all adverse events, serious adverse events.
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 posted1 May 2007 (estimated)
- Study start6 Mar 2007
- Primary completion6 Jun 2008
- Study completion6 Jun 2008
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468039
- Sponsor's protocol ID
- CLMF237A2302S1
- Status last verified
- Aug 2017
- First submitted
- 27 Apr 2007
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Bosi E, Dotta F, Jia Y, Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 May;11(5):506-15. doi: 10.1111/j.1463-1326.2009.01040.x. Epub 2009 Mar 23.
PubMed 19320662
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, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control
- ClinicalTrials.gov ID
- NCT00468039
- Acronym / sponsor ID
- CLMF237A2302S1
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- metformin, vildagliptin, initial combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2007 (actual)
- Primary completion
- 6 Jun 2008 (actual)
- Study completion
- 6 Jun 2008 (actual)
- First posted
- 1 May 2007 (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 effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vildagliptin + metformin | Experimental | Drug: vildagliptin + metformin |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
- Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
- Body mass index 22-40 kg/meter squared
- HbA1c > 11% and/or FPG >270 mg/dL
Key exclusion criteria (5 listed)
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
- 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 |
Primary outcome
glycosylated hemoglobin (HbA1c)at Baseline and week 24
Time frame: 24 weeks
5 secondary outcomes
HbA1c at Baseline and week 12
Time frame: 12 weeks
Fasting plasma glucose test (FPG) at Baseline and week 24
Time frame: 24 weeks
Weight at baseline and week 24
Time frame: 24 weeks
Responder rates assessed by HbA1c absolute reduction from baseline to endpoint greater than or equal to 0.7% after 24 weeks
Time frame: 24 weeks
Safety assessed by monitoring and recording all adverse events, serious adverse events.
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.
- Results publication: PubMed 19320662Bosi E, Dotta F, Jia Y, Goodman M. Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 May;11(5):506-15. doi: 10.1111/j.1463-1326.2009.01040.x. Epub 2009 Mar 23.
- Results for CLMF237A2302S1 from the Novartis Clinical Trials websiteLink 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
1 site 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 + metformin in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in United States.
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 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 1 site in United States. 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?
glycosylated hemoglobin (HbA1c)at Baseline and week 24 (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 NCT00468039, 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 19 Dec 2020.