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Clinical Trial Details

Trial ID: L4127
Source ID: NCT03311724
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03311724/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Tirzepatide|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in Haemoglobin A1c (HbA1c), Least squares (LS) mean was calculated using mixed model repeated measures model (MMRM) with baseline + baseline BMI group + baseline metformin flag + treatment + time + treatment\*time as fixed factors., Baseline, 3 Months | Secondary: Percentage of Participants Achieving HbA1c Target of <7.0%, Percentage of participants achieving HbA1c target of \< (less than) 7.0%., 3 Months|Change From Baseline in Fasting Blood Glucose (FBG), LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment\*time as fixed factors., Baseline, 3 Months|Change From Baseline in Body Weight, LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment\*time as fixed factors., Baseline, 3 Months|Change From Baseline in Waist Circumference, LSMean was calculated using MMRM model with baseline + baseline HbA1C group + baseline BMI group + baseline Metformin flag + treatment + time + treatment\*time as fixed factors., Baseline, 3 Months|Number of Participants With Anti Drug Antibodies, Number of participants with anti drug antibodies., Baseline through 3 Months|Number of Episodes of Total Hypoglycemia Episodes, Number of episodes of total hypoglycemia episodes with plasma glucose \<= ( less than or equal to) 54 mg/dL., Baseline through 3 Months|Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide, Pharmacokinetics (PK): Average Trough Concentration (Conctrough) of Tirzepatide., Week 4, 8 12: Pre-dose
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 111
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-10-19
Completion Date: 2018-04-24
Results First Posted: 2021-05-19
Last Update Posted: 2021-05-19
Locations: Valley Research, Fresno, California, 93720, United States|National Research Institute, Los Angeles, California, 90057, United States|Catalina Research Institute, LLC, Montclair, California, 91763, United States|University Clinical Investigators, Inc., Tustin, California, 92780, United States|Chase Medical Research, LLC, Waterbury, Connecticut, 06708, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|Solaris Clinical Research, Meridian, Idaho, 83646, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|Clinical Research Professionals, Saint Louis, Missouri, 63141, United States|Aventiv Research, Columbus, Ohio, 43213, United States|New Phase Research & Development, Knoxville, Tennessee, 37909, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Consano Clinical Research, Shavano Park, Texas, 78231, United States
URL: https://clinicaltrials.gov/show/NCT03311724