Diabetes Mellitus, Type 2Phase 3NCT00099853
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
A Phase 3 study testing Vildagliptin and pioglitazone in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vildagliptin and pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Blood glucose criteria must be met
- Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
- Body mass index (BMI) in the range 22-45
Who cannot join
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious cardiovascular complications
- Evidence of serious diabetic complications
- Laboratory value abnormalities as defined by the protocol
- Known sensitivity to pioglitazone
- Other protocol-defined exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vildagliptin, pioglitazone, Placebo
- 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.
VildagliptinDrug
Also called LAF237, Galvus
Vildagliptin 50 mg tablets
pioglitazoneDrug
pioglitazone 45 mg qd
PlaceboDrug
Vildagliptin matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin 50 mg qd + pioglitazone 45 mg qd | Experimental | Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks Receives: Drug: Vildagliptin; Drug: pioglitazone |
| Vildagliptin 50 mg bid + pioglitazone 45 mg qd | Experimental | Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks Receives: Drug: Vildagliptin; Drug: pioglitazone |
| Vildagliptin placebo + pioglitazone 45 mg qd | Placebo comparator | Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks Receives: Drug: pioglitazone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c after 24 weeks
Secondary outcomes (5)
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2004 (estimated)
- Study startMay 2004
- Primary completionJan 2008
- Study completionJan 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.
- 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
- 362 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
- NCT00099853
- Sponsor's protocol ID
- CLAF237A2304
- Status last verified
- Jan 2013
- First submitted
- 21 Dec 2004
- Last updated
- 17 Dec 2020
- Results posted
- No
Publications
Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x.
PubMed 17300592
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
- Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00099853
- Acronym / sponsor ID
- CLAF237A2304
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- type 2 diabetes, vildagliptin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Dec 2004 (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.
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin 50 mg qd + pioglitazone 45 mg qd | Experimental | Drug: Vildagliptin, Drug: pioglitazoneVildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks |
| Vildagliptin 50 mg bid + pioglitazone 45 mg qd | Experimental | Drug: Vildagliptin, Drug: pioglitazoneVildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks |
| Vildagliptin placebo + pioglitazone 45 mg qd | Placebo comparator | Drug: pioglitazone, Drug: PlaceboVildagliptin placebo + pioglitazone 45 mg qd for 24 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Blood glucose criteria must be met
- Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
- Body mass index (BMI) in the range 22-45
Key exclusion criteria (7 listed)
- Type 1 diabetes
- Pregnancy or lactation
- Evidence of serious cardiovascular complications
- Evidence of serious diabetic complications
- Laboratory value abnormalities as defined by the protocol
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 |
|---|---|---|
| VildagliptinAlso: LAF237, GalvusVildagliptin 50 mg tablets | Drug | Vildagliptin 50 mg bid + pioglitazone 45 mg qd, Vildagliptin 50 mg qd + pioglitazone 45 mg qd |
| pioglitazonepioglitazone 45 mg qd | Drug | Vildagliptin 50 mg bid + pioglitazone 45 mg qd, Vildagliptin 50 mg qd + pioglitazone 45 mg qd, Vildagliptin placebo + pioglitazone 45 mg qd |
| PlaceboVildagliptin matching placebo | Drug | Vildagliptin placebo + pioglitazone 45 mg qd |
Primary outcome
Change from baseline in HbA1c after 24 weeks
5 secondary outcomes
Change from baseline in fasting plasma glucose at 24 weeks
Patients with endpoint HbA1c <7% after 24 weeks
Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
Adverse event profile after 24 weeks of treatment
Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c
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.
- Derived from this study: PubMed 17300592Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x.
- Results for CLAF237A2304 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 and pioglitazone in people with Diabetes Mellitus, Type 2, run by Novartis Pharmaceuticals 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 3 inclusion and 7 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 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. 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?
Change from baseline in HbA1c after 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 NCT00099853, 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 17 Dec 2020.