Trial · NCT01435616
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c) | Baseline, 52 weeks | All participants who were randomized, had at least 1 dose of study medication, and at least 1 post-baseline HbA1c measurement. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Total and Nocturnal Hypoglycemia Events | Baseline to 52 weeks | All participants who were randomized, who received at least 1 dose of study drug, and had evaluable total and/or nocturnal event data. | episodes/participant/30 days | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 % | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. | percentage of participants | NUMBER |
| SECONDARY | Fasting Serum Glucose (By Laboratory Measurement) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting serum glucose data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable fasting blood glucose data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | 6 Point Self-monitored Blood Glucose (SMBG) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable SMBG data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 52 Weeks in Body Weight | Baseline, 52 weeks | All participants who were randomized, who received at least 1 dose of study drug, and had evaluable body weight data. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Hemoglobin A1c | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Insulin Dose Per Body Weight | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable insulin dose data. | units of insulin/kg body weight | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Insulin Dose Adjustments to Steady-State | Baseline to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline insulin data. | number of insulin dose adjustments | LEAST_SQUARES_MEAN |
| SECONDARY | European Quality of Life-5 Dimension (EQ-5D) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable EQ-5D data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Insulin Treatment Satisfaction Questionnaire | Up to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable ITSQ data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adult Low Blood Sugar Survey | Up to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable LBSS data. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C) | Baseline, 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline lipid measurement. | milligrams per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin | Up to 52 weeks | All participants who were randomized, had at least 1 dose of study drug, and had at least 1 post-baseline total bilirubin measurement. | percentage of participants | NUMBER |
| SECONDARY | Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR) | Baseline to 78 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable TEAR data. | percentage of participants | NUMBER |
| SECONDARY | Intra-participant Variability of the Fasting Blood Glucose (FBG) | 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline FBG data. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Total and Nocturnal Hypoglycemic Events | Baseline to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable hypoglycemia event data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia | Up to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had at least 1 post-baseline HbA1c measurement. Missing endpoints were imputed with the LOCF method, using only post-baseline data. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) | Up to 52 weeks | All participants who were randomized, received at least 1 dose of study drug, and had evaluable post-baseline liver enzyme data. | 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01435616/outcomes