Trial · NCT00707993
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin at Week 52. | Baseline and Week 52. | The change in the percentage of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline. |
| 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. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit relative to baseline. |
| Secondary | Incidence of Hypoglycemia | On occurrence (up to 52 weeks). | Percentage of participants with at least one hypoglycemic episode during 52 week study. |
| Secondary | Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥200 mg Per dL). | On Occurrence (up to 52 weeks). | The number of participants with a fasting plasma glucose value ≥ to 200 mg per dL during the 52 week study. |
| Secondary | Incidence of Hyperglycemic Rescue | On Occurrence (up to 52 weeks). | The number of participants requiring rescue for failing to achieve pre-specified glycemic targets during the 52 week study. |
| 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. | The change in the value of fasting plasma glucose collected at each week indicated including final visit relative to baseline. |
| Secondary | Change From Baseline in 2-hour Postprandial Glucose | Baseline and Week 52. | The change in postprandial (after eating a meal) glucose levels at week 52 relative to baseline. Standard 2-hour postprandial glucose (PPG) tests performed following an overnight fast and evaluated right before and after a 120-minute (2-hour) timeframe relative to ingestion of a standard oral glucose drink. |
| Secondary | Change From Baseline in Fasting Proinsulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the value of fasting proinsulin collected at each week indicated including final visit relative to baseline. |
| Secondary | Change From Baseline in Insulin | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the value of insulin collected at each week indicated including final visit relative to baseline. |
| Secondary | Change From Baseline in Proinsulin/Insulin Ratio | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the ratio value of proinsulin and insulin collected at each week indicated including final visit relative to baseline. |
| Secondary | Homeostasis Model Assessment of Beta Cell Function | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between homeostasis model assessment of beta cell function collected at each week indicated including final visit relative to baseline. Homeostasis model assessment of beta cell function measures beta cell function, calculated by a constant (20) times insulin, divided by fasting plasma glucose minus a constant (3.5). |
| Secondary | Change From Baseline in Body Weight | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | The change in body weight measured at each week indicated including final visit from baseline. |
| Secondary | Change From Baseline in Serum Lipids (Total Cholesterol) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | The change in total cholesterol measured at each week indicated including final visit from baseline. |
| Secondary | Change From Baseline in Serum Lipids (High-Density Lipoprotein Cholesterol) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | The change in high-density lipoprotein cholesterol measured at each week indicated including final visit from baseline. |
| Secondary | Change From Baseline in Serum Lipids (Low-Density Lipoprotein Cholesterol) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | The change in low-density lipoprotein cholesterol measured at each week indicated including final visit from baseline. |
| Secondary | Change From Baseline in Serum Lipids (Triglycerides) | Baseline, Week 8, Week 12, Week 26, Week 42 and Week 52. | The change in triglycerides measured at each week indicated including final visit from baseline. |
| Secondary | Change From Baseline in High Sensitivity C-reactive Protein | Baseline, Week 12, Week 26, Week 42 and Week 52. | The change between the high sensitivity C-reactive protein value collected at each week indicated including final visit from baseline. |
| Secondary | Incidence of Subjects Achieving Glycosylated Hemoglobin <=7% | Baseline and Week 52. | The percentage of participants with a value for the percentage of glycosylated hemoglobin (HbA1c; the percentage of hemoglobin that is bound to glucose) less than or equal to 6.5 and 7.0% during the 52 week study. |
| Secondary | Incidence of Glycosylated Hemoglobin Decrease From Baseline. | Baseline and Week 52. | The percentage of participants with a decrease from baseline in the percentage of glycosylated hemoglobin (the percentage of hemoglobin that is bound to glucose) greater than or equal to 0.5, 1.0, 1.5 and 2.0% during the 52 week study. |
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/registered