Trial · NCT00645099
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio) | Baseline to End Point (up to 6 months) | The primary end point analysis set consisted of 413 patients, i.e., all patients who received study medication at least once and had baseline and post-baseline TG and HDL data. Data of patients with missing TG or HDL values or who started or changed lipid-lowering medication during the trial were excluded from analysis. | Ratio | MEAN |
| SECONDARY | Change From Baseline to End Point in Triglycerides | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in High Density Lipoprotein | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Total Cholesterol | Baseline to End Point (up to 6 months) | Safety data were analyzed using the Intent-to-Treat (ITT) analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT) | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Converted Insulin | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | pmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Fasting Glucose | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B) | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post baseline data for the particular secondary efficacy parameter under discussion. | dimensionless | MEAN |
| SECONDARY | Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | dimensionless | MEAN |
| SECONDARY | Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up | 6 months | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | Participants | NUMBER |
| SECONDARY | Number of Patients With Onset of Impaired Glucose Tolerance | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement.Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | Participants | NUMBER |
| SECONDARY | Number of Patients With Impaired Fasting Glucose | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | Participants | NUMBER |
| SECONDARY | Change From Baseline at End Point of the Insulinogenic Index | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | pM/mM | MEAN |
| SECONDARY | Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin | Baseline to End Point (up to 6 months) | The secondary end point analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | pM/mM | MEAN |
| SECONDARY | Change From Baseline at End Point in Body Weight | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | kg | MEAN |
| SECONDARY | Change From Baseline at End Point in Body Mass Index (BMI) | Baseline to End Point (up to 6 months) | kg/m² | MEAN | |
| SECONDARY | Change From Baseline at End Point in Waist Circumference | Baseline to End Point (up to 6 months) | Safety data were analyzed using the ITT analysis set for safety and consisted of 459 patients, i.e., all patients who received study medication at least once and provided any post-baseline safety data. Changes from baseline could only be calculated for patients with paired data. | cm | MEAN |
| SECONDARY | Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up | 6 months | The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. In this case, the total number of patients in the analysis set depends on the number of patients without metabolic syndrome at baseline. | Participants | NUMBER |
| SECONDARY | Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS) | Baseline to End Point (up to 6 months) | The secondary endpoint analysis set included all patients who received study medication at least once and provided ≥1 post-baseline efficacy measurement. Therefore, the total number of patients in the analysis set depends on the number of patients having post-baseline data for the particular secondary efficacy parameter under discussion. | points on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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