Type 2 Diabetes MellitusPhase 4VIDANCT01862263
Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type II Diabetes
A Phase 4 study testing Vildagliptin and Insulin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 13 sites in Mexico.
Trial summary
The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin and Insulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 13 sitesMexico
- Study dates
- May 2013to Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent read and signed before any protocol procedure.
- Free will to sign the informed consent.
- Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
- Type 2 diabetes mellitus
- Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
- HbA1c between 7.5 to 9%.
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- Fasting plasma glucose (FPG) less than 270 mg/dL.
- Body mass index (BMI) between 20 to 35 kg/m2.
- Free willing to take the vildagliptin tablets during the study.
Who cannot join
- Pregnant or lactating female or without birth control method if of childbearing potential.
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
- Acute cardiovascular complications or metabolic complications within the past 4 months.
- History cerebrovascular disease during the last year.
- History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
- Ischemic heart disease (e.g. myocardial infarction, unstable angina, coronary artery bypass surgery).
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- Congestive heart failure requiring pharmacologic treatment.
- Any known serious heart condition.
- ALT and/or AST greater than three times the upper limit of the normal range.
- Serum creatinine levels greater than 1.5 mg/dL
- Malignancy including leukemia and lymphoma within the last 5 years
- Other inlcusion/exclusion criteria may apply
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Mexico13 sites
Novartis Investigative Site
Cancún, Quintana Roo, 77500
Novartis Investigative Site
Celaya, Guanajuato, 38000
Novartis Investigative Site
Culiacán, Sinaloa, 80000
Novartis Investigative Site
Guadalajara, Jalisco, 44150
Novartis Investigative Site
Guadalajara, Jalisco, 44600
Novartis Investigative Site
Guadalajara, Jalisco, 44670
Novartis Investigative Site
Metepec, State of Mexico, 52140
Novartis Investigative Site
Mexico City, Mexico City, 06700
Novartis Investigative Site
Mexico City, Mexico City, 07300
Novartis Investigative Site
Mexico City, Mexico City, 14050
Novartis Investigative Site
Monterrey, Nuevo León, 64020
Novartis Investigative Site
Monterrey, Nuevo León, 64710
Novartis Investigative Site
Puebla City, 72190
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Placebo-Controlled Study to Compare the Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Insulin.
The purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Insulin, Placebo
- Keywords
- Diabetes,, Type 2 diabetes,, Diabetes mellitus,, insulin,
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Orally active and highly selective inhibitor of DPP-4
InsulinDrug
Long- acting human insulin analog indicated to improve glycemic control
PlaceboDrug
Matching placebo of vildagliptin
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin | Experimental | Vildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day Receives: Drug: Vildagliptin; Drug: Insulin |
| Placebo | Placebo comparator | Insulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid) Receives: Drug: Insulin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with hyperglycemic events evaluated with CGM
An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL.
Measured: At 13 weeks
Secondary outcomes (14)
Number of hypoglycemia and/or hyperglycemia measured by CGM
An episode of hypoglycemia is defined as any value of glucose under 60 mg/dL, an episode of hyperglycemia is defined as any value of glucose above 140mg/dL measured by CGM.
Measured: 13 weeks
Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day
Duration and intensity of hypoglycemic episodes, measured as area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day, measured by continuous glucose monitoring
Measured: 0 to 24 hours daily for week 1, 4 and 13
Average of insulin units per day administered during the study
Change from baseline
Measured: 13 weeks
Changes from the baseline in Lipid Profile
Lipid Profile will include total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol
Measured: Baseline, 13 weeks
Change from baseline in Body weight
Weight will be measured on Kg.
Measured: Baseline, 13 weeks
Change from baseline in Blood pressure (BP),
BP will be mesured on mmHg
Measured: Baseline, 13 weeks
Change from baseline in Fasting plasma glucose (FPG),
FPG will be measured on mg/dL
Measured: Baseline, 13 weeks
Change from baseline in Hemoglobin A1C (HbA1c)
HbA1c will be measured on %
Measured: Baseline, 13 weeks
Change from baseline in Creatinine
Creatinine will be measured on mg/dL
Measured: Baseline, 13 weeks
Change from baseline in C-peptide
C-Peptide will be measured on microIU/mL
Measured: Baseline, 13 weeks
Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
ALT/AST will be measured on ratio.
Measured: Baseline, 13 week
Changes from baseline in Direct bilirubin
Bilirubin will be measure on mg/dL
Measured: Baseline, 13 weeks
Changes from baseline in Body Mass Index (BMI)
Measured: Baseline, 13 weeks
Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 191 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
- NCT01862263
- Sponsor's protocol ID
- CLAF237AMX01
- Acronym
- VIDA
- Status last verified
- Jun 2019
- First submitted
- 22 May 2013
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group Placebo-Controlled Study to Compare the Effect of 13-Week Treatment With Vildagliptin as Add-On Therapy to Improve Glucose Variability in Type 2 Diabetes Mellitus Patients Inadequately Controlled With Insulin.
- ClinicalTrials.gov ID
- NCT01862263
- Acronym / sponsor ID
- VIDA / CLAF237AMX01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes,, Type 2 diabetes,, Diabetes mellitus,, insulin,
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 May 2013 (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 purpose of the study is to assess if the addition of vildagliptin as add-on therapy improves glucose variability in type 2 diabetes mellitus (T2DM) patients inadequately controlled with insulin, with special emphasis in hypoglycemic episodes measured by continuous glucose monitoring.
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, Drug: InsulinVildagliptin 50 mg twice daily (bid) + Insulin 20 to 40 IU/day |
| Placebo | Placebo comparator | Drug: Insulin, Drug: PlaceboInsulin 20 to 40 IU/day + Vildagliptin Placebo twice daily (bid) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent read and signed before any protocol procedure.
- Free will to sign the informed consent.
- Male and female between 18 and 80 years. If female, patient must be non-fertile or of childbearing potential using a medically approved birth control method.
- Type 2 diabetes mellitus
- Patient under insulin treatment within 3 years with stable insulin NPH (Neutral ProtamineHagedorn) regimen at dose of at least 20 UI/day up to 40 UI/day for a minimum of 4 weeks prior to enrolment, only NPH and glargine insulin are allowed.
Key exclusion criteria (12 listed)
- Pregnant or lactating female or without birth control method if of childbearing potential.
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome.
- Acute cardiovascular complications or metabolic complications within the past 4 months.
- History cerebrovascular disease during the last year.
- History of Torsades de Points, ventricular tachycardia or ventricular fibrillation.
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 |
|---|---|---|
| VildagliptinOrally active and highly selective inhibitor of DPP-4 | Drug | Vildagliptin |
| InsulinLong- acting human insulin analog indicated to improve glycemic control | Drug | Placebo, Vildagliptin |
| PlaceboMatching placebo of vildagliptin | Drug | Placebo |
Primary outcome
Percentage of patients with hyperglycemic events evaluated with CGM
Time frame: At 13 weeks
An hypoglycemic event is defined as any continuous glucose monitoring (CGM) measurement less than 60 mg/dL and a hyperglycemic is define as any CGM greater than 140 mg/dL.
14 secondary outcomes
Number of hypoglycemia and/or hyperglycemia measured by CGM
Time frame: 13 weeks
Area under the curve (AUC 0-24) of the excursions of glucose values below 60 mg/dl per day
Time frame: 0 to 24 hours daily for week 1, 4 and 13
Average of insulin units per day administered during the study
Time frame: 13 weeks
Changes from the baseline in Lipid Profile
Time frame: Baseline, 13 weeks
Change from baseline in Body weight
Time frame: Baseline, 13 weeks
Change from baseline in Blood pressure (BP),
Time frame: Baseline, 13 weeks
Change from baseline in Fasting plasma glucose (FPG),
Time frame: Baseline, 13 weeks
Change from baseline in Hemoglobin A1C (HbA1c)
Time frame: Baseline, 13 weeks
Change from baseline in Creatinine
Time frame: Baseline, 13 weeks
Change from baseline in C-peptide
Time frame: Baseline, 13 weeks
Changes from baseline in alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
Time frame: Baseline, 13 week
Changes from baseline in Direct bilirubin
Time frame: Baseline, 13 weeks
Changes from baseline in Body Mass Index (BMI)
Time frame: Baseline, 13 weeks
Number of patients with adverse events, serious adverse events and death as evaluation of safety and tolerability of coadministration of vildagliptin with insulin
Time frame: 13 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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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
13 sites 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 and Insulin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 13 sites in Mexico.
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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Mexico. 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 was stopped early. Results are not available in the source record.
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?
Percentage of patients with hyperglycemic events evaluated with CGM (time frame: At 13 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 5 Jun 2019.