Trial · NCT01769378
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 24 Weeks | Baseline, 24 Weeks | Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data at both baseline and post-baseline. | percent change of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve HbA1c <7.0% and ≤6.5% at 24 Weeks | 24 Weeks | Participants who were randomized and received at least one dose of study drug with evaluable HbA1c data. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Serum Glucose (FSG) at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable FSG data at both baseline and post-baseline. LOCF was used to impute missing post-baseline values. If no data after date of randomization, the endpoint was considered missing. | milligrams per deciliter (mg/dL) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable body weight data at both baseline and post-baseline. | kilograms (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and evaluable BMI data at both baseline and post-baseline. | kilograms per/square meter kg/m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean of All 7-Point Self Monitored Plasma Glucose (SMPG) at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable SMPG data at both baseline and post-baseline. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Reported and Adjudicated Cardiovascular Events | Baseline through 24 Weeks, 30-day Follow Up | ITT population: All randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Acute Pancreatitis Events | Baseline through 24 Weeks, 30-day Follow Up | ITT population: all randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Calcitonin at 24 Weeks | Baseline, 24 Weeks | Participants who received at least one dose of study drug and evaluable calcitonin data at baseline and post-baseline. | picogram per milliliter (pg/ml) | MEDIAN |
| SECONDARY | Percentage of Participants With Self-Reported Events of Hypoglycemia | Baseline through 24 Weeks | ITT Population: all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Rate of HE Adjusted Per 30 Days | Baseline through 24 weeks | ITT population: all randomized participants who received at least one dose of study drug. | number of events/participants/30 days | MEAN |
| SECONDARY | Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia | Baseline through 24 Weeks | ITT population: all randomized participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia | Baseline through 24 Weeks | ITT population: All randomized participants who received at least one dose of study drug. | weeks | MEAN |
| SECONDARY | Dulaglutide Anti-Drug Antibodies (ADA) | Baseline up to 4 Weeks Post-Last Dose of Study Drug | ITT population: all randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Lipase | Baseline, 24 Weeks | All participants who received at least one dose of study drug and had evaluable lipase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing. | Units/Liter | MEDIAN |
| SECONDARY | Change From Baseline in Amylase | Baseline, 24 Weeks | Participants who received at least one dose of study drug and had evaluable amylase data at both baseline and post-baseline. LOCF was used to impute missing postbaseline values. If no data after date of randomization, the endpoint was considered missing. | Units/Liter | MEDIAN |
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.
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