Trial · NCT00622284
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | HbA1c Change From Baseline at Week 52 | Baseline and week 52 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| PRIMARY | HbA1c Change From Baseline at Week 104 | Baseline and week 104 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| SECONDARY | Body Weight Change From Baseline at Week 52 | Baseline and week 52 | This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule. | kg | MEAN |
| SECONDARY | Body Weight Change From Baseline at Week 104 | Baseline and week 104 | This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule. | kg | MEAN |
| SECONDARY | Incidence of Hypoglycaemic Events up to 52 Weeks | Week 52 | The treated set consisted of all patients treated with at least one dose of study drug | Patients | NUMBER |
| SECONDARY | Incidence of Hypoglycaemic Events up to 104 Weeks | Week 104 | The treated set consisted of all patients treated with at least one dose of study drug | Patients | NUMBER |
| SECONDARY | Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 | Baseline and week 52 | This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule. | mg/dL | MEAN |
| SECONDARY | Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 | Baseline and week 104 | This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule. | mg/dL | MEAN |
| SECONDARY | Percentage of Patients With HbA1c <7.0% at Week 52 | Week 52 | Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=7.0%. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c <7.0% at Week 104 | Week 104 | Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=7.0%. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c <6.5% at Week 52 | Week 52 | Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=6.5%. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c <6.5% at Week 104 | Week 104 | Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c \>=6.5%. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 | Week 104 | FAS (NCF) | Percentage of patients | NUMBER |
| SECONDARY | 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 | Baseline and week 104 | Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104). | mg/dL | MEAN |
| SECONDARY | HbA1c Change at Week 4 | Baseline and week 4 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change at Week 8 | Baseline and week 8 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change at Week 12 | Baseline and week 12 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change at Week 16 | Baseline and week 16 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change at Week 28 | Baseline and week 28 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | MEAN |
| SECONDARY | HbA1c Change at Week 40 | Baseline and week 40 | The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule. | Percent | 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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT00622284/outcomes