Diabetes Mellitus, Type 2Phase 3NCT00383578
Efficacy and Safety of Vildagliptin Compared to Metformin in Elderly Drug Naive Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin 100 mg qd and Metformin 1500 mg daily in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin 100 mg qd and Metformin 1500 mg daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2006to May 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age from 65 years to the upper age limit recommended by local prescribing information for metformin
- Drug naive patients with type 2 diabetes.
- Body mass index (BMI) in the range of 22-40 kg/m2.
- HbA1c in the range of 7 to 9% inclusive
- FPG <270 mg/dL (15 mmol/L)
Who cannot join
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agents
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes
This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin 100 mg qd, Metformin 1500 mg daily
- Keywords
- Type 2 diabetes, vildagliptin, hemoglobin A1c, metformin
- 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 100 mg qdDrug
Metformin 1500 mg dailyDrug
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Not described Receives: Drug: Vildagliptin 100 mg qd |
| Metformin | Active comparator | Not described Receives: Drug: Metformin 1500 mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: after 24 weeks of treatment
Secondary outcomes (5)
Adverse event profile
Measured: after 24 weeks of treatment
Gastrointestinal tolerability
Measured: after 24 weeks of treatment
Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%
Measured: after 24 weeks of treatment
Change from baseline in fasting plasma glucose
Measured: after 24 weeks of treatment
Change from baseline in body weight
Measured: after 24 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionMay 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
- 335 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
- NCT00383578
- Sponsor's protocol ID
- CLAF237A2398
- Status last verified
- Jan 2013
- First submitted
- 29 Sep 2006
- Last updated
- 17 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Active Controlled Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 mg qd or Metformin 1500 mg Daily in Elderly Drug Naive Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00383578
- Acronym / sponsor ID
- CLAF237A2398
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, vildagliptin, hemoglobin A1c, metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2008 (actual)
- First posted
- 3 Oct 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.
This study is designed to demonstrate the efficacy and safety of vildagliptin compared to metformin in elderly drug naive patients with type 2 diabetes
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: Vildagliptin 100 mg qd |
| Metformin | Active comparator | Drug: Metformin 1500 mg daily |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age from 65 years to the upper age limit recommended by local prescribing information for metformin
- Drug naive patients with type 2 diabetes.
- Body mass index (BMI) in the range of 22-40 kg/m2.
- HbA1c in the range of 7 to 9% inclusive
- FPG <270 mg/dL (15 mmol/L)
Key exclusion criteria (4 listed)
- A history of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agents
- 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 100 mg qd | Drug | Vildagliptin |
| Metformin 1500 mg daily | Drug | Metformin |
Primary outcome
Change from baseline in HbA1c
Time frame: after 24 weeks of treatment
5 secondary outcomes
Adverse event profile
Time frame: after 24 weeks of treatment
Gastrointestinal tolerability
Time frame: after 24 weeks of treatment
Patients with endpoint HbA1c <7% and patients with reduction in HbA1c > 0.7%
Time frame: after 24 weeks of treatment
Change from baseline in fasting plasma glucose
Time frame: after 24 weeks of treatment
Change from baseline in body weight
Time frame: after 24 weeks of treatment
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 17 Dec 2020.
- Resutls for CLAF237A2398 on 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
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 100 mg qd and Metformin 1500 mg daily 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 5 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 17 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 Germany, Switzerland. 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: after 24 weeks of treatment). 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 17 Dec 2020.