Trial · NCT01272219
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Fasting Body Weight | Week 0, Week 56 | The observed mean change from baseline in fasting body weight (%) after 56-weeks of treatment (main treatment period). |
| Primary | Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. | At Week 56 | Percentage of subjects losing at least 5% of baseline fasting body weight after 56-weeks of treatment (main treatment period). |
| Primary | Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight | At 56 weeks | Percentage of subjects losing \>10% of baseline fasting body weight after 56-weeks of treatment (main treatment period). |
| Primary | Proportion of Subjects With Onset of Type 2 Diabetes | At 160 weeks | Proportion of subjects with onset of Type 2 diabetes mellitus (T2DM) at week 160 (main + extension treatment period) among subjects with pre-diabetes at baseline - evaluated as time to onset of T2DM. Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Change From Baseline in Waist Circumference (cm) | Week 0, Week 56 | The observed mean change from baseline in waist circumference (cm) after 56-weeks of treatment (main treatment period). |
| Secondary | Change From Baseline in Waist Circumference (Subjects With Pre-diabetes at Baseline) | Week 0, week 160 | The observed mean change from baseline in waist circumference (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Pre-diabetes Status After 56 Weeks of Treatment | Week 0, Week 56 | Observed percentage of subjects with pre-diabetes status after 56 weeks of treatment (main treatment period). |
| Secondary | Pre-diabetes Status in Subject With Pre-diabetes at Baseline After 160 Weeks of Treatment | Week 0, week 160 | Observed percentage of subjects (subjects with pre-diabetes at baseline) with pre-diabetes status after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Mean Change From Baseline in Fasting Body Weight (Subjects With Pre-diabetes at Baseline) | Week 0, week 160 | The observed mean change from baseline in fasting body weight (subjects with pre-diabetes at baseline) after 160 weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Proportion of Subjects Losing at Least 5% and Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (Subjects With Pre-diabetes at Baseline) | At 160 weeks | Percentage of subjects losing \>=5% and percentage of subjects losing \>10% of baseline fasting body weight (pre-diabetic subjects at baseline) after 160-weeks of treatment (main + extension treatment period). Subjects included in FAS, who were stratified to 160-weeks of treatment (i.e., excluding 37 subjects with pre-diabetes who entered the re-randomised period and including 6 subjects without pre-diabetes incorrectly stratified to the 160-week treatment period). |
| Secondary | Change From Week 56 in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) | Week 56, Week 68 | The observed mean change in fasting body weight (%) from week 56 to week 68 in re-randomised subjects (with no pre-diabetes at baseline) after 12-weeks of treatment (re-randomised treatment period). |
| Secondary | Change From Baseline in Fasting Body Weight (%) (Re-randomised Subjects With No Pre-diabetes) | Week 0, Week 68 | The observed mean change from baseline in fasting body weight (%) in re-randomised subjects (with no pre-diabetes at baseline) after 68 weeks of treatment (main + re-randomised treatment period). |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01272219/registered