| Trial ID: | L5665 |
| Source ID: | NCT01686932
|
| Associated Drug: |
Vildagliptin
|
| Title: |
Vildagliptin vs Sitagliptin add-on to Insulin - Impact on Glycemic Profile and Correlation of Hypoglycemic Episodes and Heart Function
|
| Acronym: |
CGM-VISIT
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01686932/results
|
| Conditions: |
Diabetes Mellitus Type 2
|
| Interventions: |
DRUG: Vildagliptin|DRUG: Sitagliptin
|
| Outcome Measures: |
Primary: Hypoglycemic Profile of Vildagliptin Compared to Sitagliptin Over 4 Days After 8 Weeks of Treatment in Period 1 & 2, The hypoglycemic profile is defined as the area under the curve glucose-time profile obtained by continuous glucose monitoring Interstitial glucose values below 3.9 mmol/L (averaged over 5 minutes) were considered relevant for the estimation of the interstitial glucose AUC in the hypoglycemic range These AUC\<3.9mmol/L/5min. values were summed up over 4 days (unit: mmol/L/4d) or over 24 hours at measurement Days 2, 3, 4, and 5 (unit: mmol/L/24h). Lower values for AUC reflect less intense hypoglycemia., baseline and 0-24 hours post-dose on Days 2 to 5 | Secondary: Number of Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment., Hypoglycemic events are defined as blood glucose values \<70 mg/dL measured by a self-monitored blood glucose (SMBG) or continuous glucose monitoring (CGM) measurement regardless of any symptoms suggestive of low blood glucose., after 8 weeks period 1 and Period 2|Mean Duration of Hypoglycemic Events (Min.) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2, the mean duration of hypoglycemic events is detected by continuous glucose monitoring (CGM)measurement., after 8 weeks for Period 1 & Period 2|Mean Amplitudes of Hypoglycemic Events (mmol/L) Measured With Continuous Glucose Monitoring (CGM) Over 4 Days After 8 Weeks of Treatment for Period 1 & Period 2, To evaluate by CGM measurement the grade of severity of hypoglycemia measured as the mean amplitude over 4 days after 8 weeks of treatment in Period 1 \& Period 2, after 8 weeks Period 1 & Period 2|Number of Severe Hypoglycemic Events During Vildagliptin Treatment Compared to Sitagliptin Treatment After 8 Weeks of Treatment in Period 1 and Period 2, Severe hypoglycemic events are defined as any episode requiring the assistance of another party or measured plasma glucose levels of \<40 mg /dL. Assessed by self-monitored blood glucose (SMBG)After 8 weeks of treatment in Period 1 and Period 2, after 8 weeks Period 1 & Period 2|Glucose Fluctuations During the Day Under Vildagliptin Treatment Compared to Sitagliptin Treatment on Day 2 After 8 Weeks of Treatment Period 1 & Period 2, Glucose fluctuations are assessed by the mean amplitude of glycemic excursions (MAGE) and standard deviations (SD) (Service et al., 1970). on day 2 after 8 weeks of treatment Period 1 \& Period 2, Day 2 after 8 weeks of treatment Period 1 & Period 2|Number of Participants With ECG Abnormalities Depending on Hypoglycemic Events After 8 Weeks of Treatment Period 1 & Period 2, ECG abnormalities are defined as either: • Occurrence of \>30 ventricular extrasystoles (VES) per hour or • Occurrence of ≥2 consecutive VES (Couplets) or • Occurrence of ≥3 consecutive VES (Triplets) or • QT-time corrected for heart rate (QTc) \>440 ms. after 8 weeks of treatment Period 1 \& Period 2, after 8 weeks of treatment Period 1 & Period 2|Change From Baseline of Inflammatory Biomarkers High Sensitivity C-reactive Protein (hsCRP) After 8 Weeks of Treatment in Period 1 & Period 2, The inflammatory biomarkers hsCRP was assessed at baseline and after 8 weeks of treatment Period 1 \& Period 2, Baseline, after 8 weeks Period 1 & Period 2|Change From Baseline of Inflammatory Biomarkers Interleukin 6 (IL-6) After 8 Weeks of Treatment in Period 1 & Period 2, The inflammatory biomarkers IL-6 was assessed at baseline and after 8 weeks of treatment Period 1 \& Period 2, Baseline, after 8 weeks Period 1 & Period 2|Percentage Change From Baseline of Pro-insulin/C-peptide Ratios After 8 Weeks of Treatment Period 1 & Period 2, Percentage Change from baseline of pro-insulin/C-peptide ratios after 8 weeks of treatment Period 1 \& Period 2 Higher pro-insulin / C-peptide ratios (expressing disproportional hyperproinsulinemia) may be associated with increasing beta cell dysfunction and more inefficient pro-insulin processing, Baseline, after 8 weeks Period 1 & Period 2|Number of Occurrence of Pre-defined ECG Findings During 4 Days of Continuous ECG Monitoring at Baseline and in the 8th Week of Periods 1 and 2, Number of Occurrence of pre-defined ECG findings during 4 days of continuous ECG monitoring at baseline and in the 8th week of Periods 1 and 2. ECG data were continuously recorded and analyzed over a period of 4 days simultaneously with continuous glucose monitoring. It assessed number of any Vertical Electric(al) Sounding (VES), number of 2 consecutive VES \[couplets\], and number of \>3 consecutive VES \[salves\], after 8 weeks Period 1 & Period 2
|
| Sponsor/Collaborators: |
Sponsor: Novartis Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
51
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2012-11
|
| Completion Date: |
2014-09
|
| Results First Posted: |
2015-10-02
|
| Last Update Posted: |
2016-03-02
|
| Locations: |
Novartis Investigative Site, Berlin, 10115, Germany|Novartis Investigative Site, Berlin, 13055, Germany|Novartis Investigative Site, Dortmund, 44137, Germany|Novartis Investigative Site, Dresden, 01307, Germany|Novartis Investigative Site, Elsterwerda, 04910, Germany|Novartis Investigative Site, Falkensee, 14612, Germany|Novartis Investigative Site, Magdeburg, 39112, Germany|Novartis Investigative Site, Neuss, 41460, Germany|Novartis Investigative Site, Potsdam, 14469, Germany|Novartis Investigative Site, Sulzbach-Rosenberg, 92237, Germany|Novartis Investigative Site, Wallerfing, 94574, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01686932
|
