Trial · NCT00622284
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | HbA1c Change From Baseline at Week 52 | Baseline and week 52 | This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications. |
| Primary | HbA1c Change From Baseline at Week 104 | Baseline and week 104 | This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications. |
| Secondary | Body Weight Change From Baseline at Week 52 | Baseline and week 52 | This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications. |
| Secondary | Body Weight Change From Baseline at Week 104 | Baseline and week 104 | This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications. |
| Secondary | Incidence of Hypoglycaemic Events up to 52 Weeks | Week 52 | A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L) |
| Secondary | Incidence of Hypoglycaemic Events up to 104 Weeks | Week 104 | A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L) |
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline at Week 52 | Baseline and week 52 | This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications. |
| Secondary | Fasting Plasma Glucose (FPG) Change From Baseline at Week 104 | Baseline and week 104 | This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications. |
| Secondary | Percentage of Patients With HbA1c <7.0% at Week 52 | Week 52 | The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. |
| Secondary | Percentage of Patients With HbA1c <7.0% at Week 104 | Week 104 | The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c \>= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. |
| Secondary | Percentage of Patients With HbA1c <6.5% at Week 52 | Week 52 | The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c \>= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c \>= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. |
| Secondary | Percentage of Patients With HbA1c <6.5% at Week 104 | Week 104 | The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c \>= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c \>= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications. |
| Secondary | Percentage of Patients With HbA1c Lowering by 0.5% at Week 104 | Week 104 | Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104 |
| Secondary | 2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104 | Baseline and week 104 | This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications. |
| Secondary | HbA1c Change at Week 4 | Baseline and week 4 | Difference of base percent value \[Week x(%) - baseline (%)\] |
| Secondary | HbA1c Change at Week 8 | Baseline and week 8 | |
| Secondary | HbA1c Change at Week 12 | Baseline and week 12 | |
| Secondary | HbA1c Change at Week 16 | Baseline and week 16 | |
| Secondary | HbA1c Change at Week 28 | Baseline and week 28 | |
| Secondary | HbA1c Change at Week 40 | Baseline and week 40 |
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
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