A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
Trial · NCT01644500
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in HbA1c at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Attaining HbA1c of <7% or ≤6.5% at 26 Weeks | 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. Last observation carried forward (LOCF) methodology was used to impute missing post-baseline values. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | millimoles per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) Profiles at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Rate of Hypoglycemic Episodes | Baseline through 26 Weeks | Participants who had been randomized, received at least one dose of study drug, and had evaluable hypoglycemic data. | episodes/participant/30 days | MEAN |
| SECONDARY | Number of Participants With Self-Reported Hypoglycemic Episodes | Baseline through 26 Weeks | All participants who were randomized and received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment 2 Steady-state Beta (β) - Cell Function (HOMA2-%B) at 26 Weeks | Baseline, up to 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values. | percentage of HOMA2-%B | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Homeostasis Model Assessment 2 Insulin Sensitivity - Cell Function (HOMA2-%S) at 26 Weeks | Baseline, up to 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. LOCF methodology was used to impute missing post-baseline values. | percentage of HOMA2-%S | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pancreatic Enzymes at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement and had evaluable pancreatic enzyme data. | units per liter (u/L) | MEAN |
| SECONDARY | Change From Baseline in Serum Calcitonin at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable serum calcitonin data. | picomoles per liter (pmol/L) | MEAN |
| SECONDARY | Change From Baseline in Sitting Blood Pressure at 26 Weeks | Baseline, 26 Weeks | All participants who were randomized, received at least one dose of study drug, and had evaluable blood pressure data. | millimeters of mercury (mmHg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Sitting Pulse Rate at 26 Weeks | Baseline, 26 Weeks | All participants who were randomized, received at least one dose of study drug, and had evaluable pulse rate data. | beats per minute (bpm) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Electrocardiogram (ECG) Parameters, Fridericia Corrected QT (QTcF) Interval and P-R Wave (PR) Interval at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ECG data. | milliseconds (msec) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate From ECG at 26 Weeks | Baseline, 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ECG data. | bpm | MEAN |
| SECONDARY | Change From Baseline in Body Weight at 26 Weeks | Baseline, 26 Weeks | All participants who were randomized, received at least one dose of study drug, and had evaluable body weight data. | kilogram (kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Mass Index (BMI) at 26 Weeks | Baseline, 26 Weeks | All participants who were randomized, received at least one dose of study drug, and had evaluable BMI data. | kilograms per meter squared (kg/m^2) | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Developing Antibodies to Dulaglutide | Baseline through 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable ADA data. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Cardiovascular Events | Baseline through 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | number of participants | NUMBER |
| SECONDARY | Number of Participants With Adjudicated Pancreatitis | Baseline through 26 Weeks | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, and had at least one post-baseline HbA1c measurement. | participants | NUMBER |
| SECONDARY | European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score Responses at 26 Weeks | Week 26 | Participants who had been randomized, received at least one dose of study drug, had a baseline HbA1c measurement, had at least one post-baseline HbA1c measurement, and had evaluable EQ-5D data. | 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
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