Trial · NCT00707993
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 in Glycosylated Hemoglobin at Week 52. | Baseline and Week 52. | Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF). | percentage of Glycosylated Hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin | Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34 and Week 42. | Randomized participants who received at least 1 dose of study drug, had measurements at Baseline and at the visit, and who met pre-specified criteria (no major protocol violations) for inclusion in the Per Protocol Set. Missing data were imputed using last observation carried forward (LOCF). | percentage of Glycosylated Hemoglobin | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Hypoglycemia | On occurrence (up to 52 weeks). | Percentages based on the number of Safety Set participants in each treatment group. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL). | On Occurrence (up to 52 weeks). | All randomized participants who had at least 1 dose of study medication (full analysis set). | participants | NUMBER |
| SECONDARY | Incidence of Hyperglycemic Rescue | On Occurrence (up to 52 weeks). | All randomized participants who had at least 1 dose of study medication (full analysis set). Participants who discontinued prior to Week 2 were excluded from analysis. | participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 26, Week 34, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Postprandial Glucose | Baseline and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set). | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Proinsulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | pmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Insulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mcIU/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Proinsulin/Insulin Ratio | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Homeostasis Model Assessment of Beta Cell Function | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | percent score of beta cell function | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Lipids (Total Cholesterol) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Lipids (Triglycerides) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein | Baseline, Week 12, Week 26, Week 42 and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | mg/L | LEAST_SQUARES_MEAN |
| SECONDARY | Incidence of Subjects Achieving Glycosylated Hemoglobin <=7% | Baseline and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | percentage of participants | NUMBER |
| SECONDARY | Incidence of Glycosylated Hemoglobin Decrease From Baseline. | Baseline and Week 52. | All randomized participants who had at least 1 dose of study medication (full analysis set) with last observation carried forward. | percentage of participants | NUMBER |
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/NCT00707993/outcomes