Type 2 DiabetesPhase 4NCT01757587
Galvus (Vildagliptin) vs Placebo in Combination With Metformin and Insulin
A Phase 4 study testing Vildagliptin in people with Type 2 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
Trial summary
The main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Mar 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated for at least 3 months with metformin (at the maximum tolerated dose (for at least 1 month) + / - sulfamide and basal insulin
- Patient with an HbA1c between 7 and 9% at the inclusion visit
- Patients able to use a continuous glucose monitoring system,
Who cannot join
- Patients already receiving a specific treatment of postprandial (GLP1, ..)
- Patients with type 1 diabetes, or secondary diabetes
- Patients with eating disorders
- Patients with major complications of diabetes
- Patients participating in another clinical trial
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled by Metformin and Basal Insulin, This One Having Been Properly Titrated.
The main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.
The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c less than 7%) after 3 months of treatment with Galvus or placebo
Read the detailed description
- Visit V1 : screening
- Inclusion visit V2: Be verified inclusion criteria of patient. At the inclusion visit will be collected:
- Informed consent to participate in the study…
- The following data: age, duration of diabetes, usual basal insulin dose, other co-morbidities : hypertension, complications of diabetes, dyslipidemia, smoking (and their associated treatments).
- Data from physical examination and in particular: weight, BMI, waist circumference, systolic blood pressure (SBP) and diastolic (DBP)
- Therapeutic adjustments can be made. In the case of inefficient combination with a sulphonylurea (HbA1c> 7%), it will be stopped and basal insulin will be titrated during the run- in period (2 months) in order to obtain a good control of fasting glucose.
- Visit V3 : At the randomization visit, be collected the results of HbA1c and other biological assessment (FPG, fasting lipid profile). Moreover, the insulin will be collected and the patient will receive the treatment for 3 months (for ex Galvus in this case according to randomisation).
- Visit V4a the glycemic holter will be introduced and removed 5 days later (at visit V4B). The interstitial glucose will be calibrated during the Holter by the blood glucose. When collecting the glycemic holter, patients will also have a clinical examination and a new biological assessment (HbA1c, FPG, C peptide, fasting lipids ...) and an assessment of their dietary intake during the port the holter (overall calorie intake: cal + G, L, P)
- Visit V5 : the patient will receive the treatment for 3 months (placebo at this visit according the example cited above ).
- Visit V6A, it will be the same as for the visit V4a, the glycemic holter will be introduced and removed at V6B visit. Similarly, in the collection of glycemic holter, patients will also have a new clinical examination, laboratory evaluation (HbA1c, FPG, fasting lipids ...) and a dietary assessment (overall calorie intake: cal + G, L, P).
- Conditions
- Type 2 Diabetes
- Being tested
- Vildagliptin, Placebo
- Keywords
- Type 2 Diabetes, Galvus, basal insulin, HbA1c
- 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 Metformin and basal insulin
50 mg, 2 tablets/day on 3 months, both periods of treatment
PlaceboDrug
Also called Metformin and insulin basal
50mg 2 tablets / day on 3 months, both periods of treatment
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Active comparator | Not described Receives: Drug: Vildagliptin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients responding to treatment (HbA1c less than 7%)
Measured: after 3 months of treatment with Galvus or placebo
Secondary outcomes (1)
Compare HbA1c and other clinical and laboratory parameters (fasting plasma glucose (FPG), fasting lipids, weight)
Measured: after 3 months of treatment with Galvus or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia FRANC, MD, Principal investigator, CH Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757587
- Sponsor's protocol ID
- 2011-001813-14
- Status last verified
- Jul 2015
- First submitted
- 8 Feb 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Galvus (Vildagliptin) Efficacy Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled by Metformin and Basal Insulin, This One Having Been Properly Titrated.
- ClinicalTrials.gov ID
- NCT01757587
- Acronym / sponsor ID
- 2011-001813-14
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Galvus, basal insulin, HbA1c
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Dec 2012 (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 main objective is to show that the addition of Galvus versus placebo in patients with type 2 diabetes treated with metformin (at the maximum tolerated dose) and basal insulin properly titrated, allows a greater proportion of patients achieving an HbA1c below 7%.
The primary efficacy endpoint was the percentage of patients responding to treatment (HbA1c less than 7%) after 3 months of treatment with Galvus or placebo
Detailed description
- Visit V1 : screening
- Inclusion visit V2: Be verified inclusion criteria of patient. At the inclusion visit will be collected:
- Informed consent to participate in the study…
- The following data: age, duration of diabetes, usual basal insulin dose, other co-morbidities : hypertension, complications of diabetes, dyslipidemia, smoking (and their associated treatments).
- Data from physical examination and in particular: weight, BMI, waist circumference, systolic blood pressure (SBP) and diastolic (DBP)
- Therapeutic adjustments can be made. In the case of inefficient combination with a sulphonylurea (HbA1c> 7%), it will be stopped and basal insulin will be titrated during the run- in period (2 months) in order to obtain a good control of fasting glucose.
- Visit V3 : At the randomization visit, be collected the results of HbA1c and other biological assessment (FPG, fasting lipid profile). Moreover, the insulin will be collected and the patient will receive the treatment for 3 months (for ex Galvus in this case according to randomisation).
- Visit V4a the glycemic holter will be introduced and removed 5 days later (at visit V4B). The interstitial glucose will be calibrated during the Holter by the blood glucose. When collecting the glycemic holter, patients will also have a clinical examination and a new biological assessment (HbA1c, FPG, C peptide, fasting lipids ...) and an assessment of their dietary intake during the port the holter (overall calorie intake: cal + G, L, P)
- Visit V5 : the patient will receive the treatment for 3 months (placebo at this visit according the example cited above ).
- Visit V6A, it will be the same as for the visit V4a, the glycemic holter will be introduced and removed at V6B visit. Similarly, in the collection of glycemic holter, patients will also have a new clinical examination, laboratory evaluation (HbA1c, FPG, fasting lipids ...) and a dietary assessment (overall calorie intake: cal + G, L, P).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin | Active comparator | Drug: Vildagliptin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients treated for at least 3 months with metformin (at the maximum tolerated dose (for at least 1 month) + / - sulfamide and basal insulin
- Patient with an HbA1c between 7 and 9% at the inclusion visit
- Patients able to use a continuous glucose monitoring system,
Key exclusion criteria (6 listed)
- Patients already receiving a specific treatment of postprandial (GLP1, ..)
- Patients with type 1 diabetes, or secondary diabetes
- Patients with eating disorders
- Patients with major complications of diabetes
- Patients participating in another clinical trial
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: Metformin and basal insulin50 mg, 2 tablets/day on 3 months, both periods of treatment | Drug | Vildagliptin |
| PlaceboAlso: Metformin and insulin basal50mg 2 tablets / day on 3 months, both periods of treatment | Drug | Placebo |
Primary outcome
Proportion of patients responding to treatment (HbA1c less than 7%)
Time frame: after 3 months of treatment with Galvus or placebo
1 secondary outcome
Compare HbA1c and other clinical and laboratory parameters (fasting plasma glucose (FPG), fasting lipids, weight)
Time frame: after 3 months of treatment with Galvus or placebo
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 30 Jul 2015.
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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.
Sylvia FRANC, MD principal investigator
CH Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vildagliptin in people with Type 2 Diabetes, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 1 site in France.
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 6 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 30 Jul 2015. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients responding to treatment (HbA1c less than 7%) (time frame: after 3 months of treatment with Galvus or placebo). 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 30 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.