Trial · NCT01528254
VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
NCT01528254, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2020-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus. Trials, record NCT01528254. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01528254
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VERIFY:A Study to Compare Combination Regimen With Vildagliptin & Metformin Versus Metformin in Treatment-naïve Patients With Type 2 Diabetes Mellitus
- NCT number
- NCT01528254
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,004 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Placebo of vildagliptin, vildagliptin, Metformin
- First posted
- 2012-02-07
- Last updated
- 2020-09-24
- Other registries' IDs
- eudract:2011-003712-23
- Results first posted
- 2020-04-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Initial Treatment Failure | Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Treatment failure was defined as two consecutive scheduled visits with HbA1c \>= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits. Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit. |
| Secondary | Rate of Loss in Glycemic Control During Period 1 | Visit 5 (Week 26) to End of Period 1 | The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from Week 26 up to and including the end of Period 1 visit was included in the analysis. Baseline HbA1c was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement was missing. End of Period 1 was defined as the final post-baseline assessment obtained at any visit within Period 1 (scheduled or unscheduled), up to the last scheduled visit. |
| Secondary | Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2 | From 26 weeks after start of Period 2 to end of Period 2 | The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from 26 weeks after the start of Period 2 to the end of Period 2 were included in the analysis, for participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis. |
| Secondary | Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1 | Visit 5 (Week 26) to End of Period 1 | Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from Week 26 to the end of Period 1 was included in the analysis. Baseline FPG was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement is missing. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis. |
| Secondary | Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2 | From 26 weeks after start of Period 2 to end of Period 2 | Rate of loss in glycemic control was estimated using the slope of FPG over time (years). FPG (fasting plasma glucose) data from 26 weeks after the start of Period 2 to then end of Period 2 was included in the analysis. Only participants who started insulin therapy in Period 3 or discontinued during Period 2 due to being unable or unwilling to initiate insulin therapy in period 3 were included. Participants who completed the study in Period 1 or Period 2 were not be included in the analysis. |
| Secondary | Rate of Loss of Beta Cell Function From Baseline to End of Study | Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | The rate of change of beta cell function was assessed using the slope of AUC of ISR/G over time (years) where AUC of ISR/G is defined as (Area under curve of Insulin secretion rate (derived using c-peptide))/(Area under curve of Glucose), using meal-test data from 0 to 120 minutes. Baseline AUC of ISR/G was derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements were missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively. |
| Secondary | Rate of Change in Insulin Sensitivity From Baseline to End of Study | Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | The rate of change of insulin sensitivity is assessed using the slope of OGIS over time (years) where Oral glucose insulin sensitivity (OGIS) was calculated as a function of glucose and insulin, using meal-test data from 0 to 120 minutes. Baseline OGIS is derived based on samples obtained on day 1, or samples obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurements are missing. Three analyses were included, using data from Week 13 to the end of Period 1, end of Period 2 and end of study, respectively. |
| Secondary | Percentage of Participants With Adverse Events, Serious Adverse Events and Death | From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) in each treatment arm to demonstrate that LAF237 is safe for the treatment of naïve patients with type 2 diabetes mellitus through the monitoring of relevant clinical and laboratory safety parameters. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Initial Treatment Failure | Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Full Analysis Set (FAS) | Rate (%) | NUMBER |
| SECONDARY | Rate of Loss in Glycemic Control During Period 1 | Visit 5 (Week 26) to End of Period 1 | Full Analysis Set (FAS) | Rate (%) | MEAN |
| SECONDARY | Rate of Loss in Glycemic Control in HbA1c Over Time During Period 2 | From 26 weeks after start of Period 2 to end of Period 2 | Full Analysis Set (FAS) | Rate (%) | MEAN |
| SECONDARY | Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) During Period 1 | Visit 5 (Week 26) to End of Period 1 | Full Analysis Set (FAS) | Rate (%) | MEAN |
| SECONDARY | Rate of Loss in Glycemic Control in Fasting Plasma Glucose (FPG) Over Time During Period 2 | From 26 weeks after start of Period 2 to end of Period 2 | Full Analysis Set (FAS) | Rate (%) | MEAN |
| SECONDARY | Rate of Loss of Beta Cell Function From Baseline to End of Study | Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Full Analysis Set (FAS) meal-test subset | Rate (%) | MEAN |
| SECONDARY | Rate of Change in Insulin Sensitivity From Baseline to End of Study | Visit 4 (Week 13), End of Period 1, End of Period 2, End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Full Analysis Set (FAS) meal-test subset | Rate (%) | MEAN |
| SECONDARY | Percentage of Participants With Adverse Events, Serious Adverse Events and Death | From first dose of study treatment until End of Study (Study Drug Discontinuation or Premature Subject Discontinuation) | Safety Set (SAF). Percentages are based on the number of patients starting each period. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Initial Treatment Failure | Vilda 50mg Bid + Metformin | Weeks 13-52 | 7.81 | 95% Confidence Interval 6.28 to 9.70 | Rate (%) |
| Time to Initial Treatment Failure | Placebo + Metformin | Weeks 13-52 | 19.97 | 95% Confidence Interval 17.58 to 22.65 | Rate (%) |
| Time to Initial Treatment Failure | Vilda 50mg Bid + Metformin | Year 2 | 17.79 | 95% Confidence Interval 15.49 to 20.38 | Rate (%) |
| Time to Initial Treatment Failure | Placebo + Metformin | Year 2 | 34.67 | 95% Confidence Interval 31.72 to 37.82 | Rate (%) |
| Time to Initial Treatment Failure | Vilda 50mg Bid + Metformin | Year 3 | 31.24 | 95% Confidence Interval 28.35 to 34.33 | Rate (%) |
| Time to Initial Treatment Failure | Placebo + Metformin | Year 3 | 48.31 | 95% Confidence Interval 45.12 to 51.61 | Rate (%) |
| Time to Initial Treatment Failure | Vilda 50mg Bid + Metformin | Year 4 | 39.84 | 95% Confidence Interval 36.74 to 43.11 | Rate (%) |
| Time to Initial Treatment Failure | Placebo + Metformin | Year 4 | 59.29 | 95% Confidence Interval 56.08 to 62.53 | Rate (%) |
| Time to Initial Treatment Failure | Vilda 50mg Bid + Metformin | Year 5 | 46.41 | 95% Confidence Interval 43.20 to 49.74 | Rate (%) |
| Time to Initial Treatment Failure | Placebo + Metformin | Year 5 | 66.57 | 95% Confidence Interval 63.43 to 69.69 | Rate (%) |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vilda 50mg Bid + Metformin | 998 | |
| Overall Study | STARTED | Placebo + Metformin | 1,003 | |
| Overall Study | Safety Set | Vilda 50mg Bid + Metformin | 998 | |
| Overall Study | Safety Set | Placebo + Metformin | 1,001 | |
| Overall Study | Full Analysis Set (FAS) | Vilda 50mg Bid + Metformin | 983 | |
| Overall Study | Full Analysis Set (FAS) | Placebo + Metformin | 989 | |
| Overall Study | Completed Treatment Period 1 | Vilda 50mg Bid + Metformin | 458 | |
| Overall Study | Completed Treatment Period 1 | Placebo + Metformin | 273 | |
| Overall Study | Completed Treatment Period 2 | Vilda 50mg Bid + Metformin | 244 | |
| Overall Study | Completed Treatment Period 2 | Placebo + Metformin | 399 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events1,068
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Vilda 50mg Bid + Metformin | 104 | 998 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Metformin | 104 | 1,001 | |
| other | Diarrhoea | Gastrointestinal disorders | Total | 208 | 1,999 | |
| other | Bronchitis | Infections and infestations | Vilda 50mg Bid + Metformin | 58 | 998 | |
| other | Bronchitis | Infections and infestations | Placebo + Metformin | 59 | 1,001 | |
| other | Bronchitis | Infections and infestations | Total | 117 | 1,999 | |
| other | Influenza | Infections and infestations | Vilda 50mg Bid + Metformin | 93 | 998 | |
| other | Influenza | Infections and infestations | Placebo + Metformin | 64 | 1,001 | |
| other | Influenza | Infections and infestations | Total | 157 | 1,999 | |
| other | Nasopharyngitis | Infections and infestations | Vilda 50mg Bid + Metformin | 104 | 998 |
1 to 10 of 1,068Source ClinicalTrials.gov
See all 1,068 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vilda 50mg Bid + Metformin | 13 | 998 |
| Total, all-cause mortality | Placebo + Metformin | 9 | 1,001 |
| Total, all-cause mortality | Total | 22 | 1,999 |
| Total, other adverse events | Vilda 50mg Bid + Metformin | 582 | 998 |
| Total, other adverse events | Placebo + Metformin | 566 | 1,001 |
| Total, other adverse events | Total | 1,148 | 1,999 |
| Total, serious adverse events | Vilda 50mg Bid + Metformin | 166 | 998 |
| Total, serious adverse events | Placebo + Metformin | 183 | 1,001 |
| Total, serious adverse events | Total | 349 | 1,999 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01528254
GET https://conductscience.org/api/trials/v1/NCT01528254/results?page=2