Diabetes Mellitus, Type 2Phase 3NCT00494884
Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
A Phase 3 study testing vildagliptin in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in Germany.
Trial summary
This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- vildagliptin
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Jul 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 85 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method
- Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
- Agreement to maintain the same dose of metformin throughout the study
- Age in the range of 18-85 years inclusive.
- HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
- Agreement to maintain prior diet and exercise habits during the full course of the study
- Ability to comply with all study requirements and signed informed consent to participate in the study.
Who cannot join
- Pregnant or lactating female
- A history of:
- type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
- acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- Any of the following significant laboratory abnormalities:
- ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
Show all 11Show fewer
- Direct bilirubin greater than the upper limit of the normal range at visit 1.
- Serum creatinine levels equal to or greater than 1.5 mg/dL (132 umol/L) males, equal to or greater than 1.4 mg/dL (123 umol/L) females, or a history of abnormal creatinine clearance at visit 1.
- Clinically significant TSH values outside of normal range at visit 1.
- Clinically significant laboratory abnormalities, confirmed by repeat measurement, other than hyperglycemia, hyperinsulinemia, and glycosuria at visit 1 Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
This study will investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- vildagliptin
- Keywords
- Type 2 diabetes, vildagliptin, metformin 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.
vildagliptinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HbA1c
Measured: 24 weeks
Secondary outcomes (5)
Change from baseline in fasting plasma glucose
Measured: 24 weeks
Adverse event profiles including gastrointestinal tolerability and hypoglycemia
Measured: 24 weeks
Responder rates
Measured: 24 weeks
Change from baseline in insulin and proinsulin in a subgroup of patients
Measured: 24 weeks
Change in systolic and diastolic blood pressure
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 posted2 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2008
- Study completionJul 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.
- 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
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. W. E. Schmidt, Study director, Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494884
- Sponsor's protocol ID
- CLAF237ADE02
- Status last verified
- Feb 2017
- First submitted
- 29 Jun 2007
- Last updated
- 27 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group Study to Investigate the Glucose Lowering Effect, Safety and Tolerability of 24 Weeks Treatment With Vildagliptin 100 mg o.d. Versus Placebo Followed by a 12 Weeks Treatment Period With Open-label Vildagliptin 100 mg o.d. as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin
- ClinicalTrials.gov ID
- NCT00494884
- Acronym / sponsor ID
- CLAF237ADE02
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes, vildagliptin, metformin combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jul 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 investigate efficacy and safety of vildagliptin in patients with low baseline levels starting at an HbA1C level of 6.5% to support convenient early intervention with combination therapies. In parallel, morning and evening dosing will be evaluated in this patient population for the first time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male, non-fertile female or female of childbearing potential using a medically approved birth control method
- Patients who have received metformin for at least three months prior to visit 1 and have been on a stable dose for a minimum of 8 weeks prior to visit 1
- Agreement to maintain the same dose of metformin throughout the study
- Age in the range of 18-85 years inclusive.
- HbA1c in the range of 6.5 - 8.0% (inclusive) at visit 1
Key exclusion criteria (11 listed)
- Pregnant or lactating female
- type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing's syndrome and acromegaly.
- acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
- ALT, AST greater than 2 times the upper limit of the normal range at visit 1.
- Direct bilirubin greater than the upper limit of the normal range at visit 1.
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 | – |
Primary outcome
Change from baseline in HbA1c
Time frame: 24 weeks
5 secondary outcomes
Change from baseline in fasting plasma glucose
Time frame: 24 weeks
Adverse event profiles including gastrointestinal tolerability and hypoglycemia
Time frame: 24 weeks
Responder rates
Time frame: 24 weeks
Change from baseline in insulin and proinsulin in a subgroup of patients
Time frame: 24 weeks
Change in systolic and diastolic blood pressure
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 27 Feb 2017.
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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.
Prof. Dr. W. E. Schmidt study director
Ruhr-Universitat Bochum, Medizinische Klinik, St. Josef Hospital, Gudrunstr. 56, D-44791 Bochum, Telefon: 0234-509-2311, Telefax: 0234-509-2309
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 in people with Diabetes Mellitus, Type 2, run by Novartis at 1 site in Germany.
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 7 inclusion and 11 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 27 Feb 2017. 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 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: 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 27 Feb 2017.