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Clinical Trial Details

Trial ID: L4061
Source ID: NCT02072096
Associated Drug: Glimepiride
Title: A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)
Acronym: IMPERIUM
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02072096/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Glimepiride|DRUG: Metformin|DRUG: Pioglitazone|DRUG: Acarbose|DRUG: Linagliptin|DRUG: Sitagliptin|DRUG: Liraglutide|DRUG: Insulin Glargine|DRUG: Exenatide once weekly (QW)|DRUG: Exenatide twice daily (BID)
Outcome Measures: Primary: Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia, Failed to reach and maintain HbA1c target, without clinically significant hypoglycemia, is defined as having 2 consecutive HbA1c \> upper limit of HbA1c target over 12 weeks starting from Week 24 for participants with HbA1c data beyond Week 24, or Week 24 HbA1c \> upper limit of HbA1c target for participants without HbA1c data beyond Week 24. Clinically significant hypoglycemia is defined as any severe hypoglycemia or repeated hypoglycemia interrupting participants activities or sleep and associated with blood glucose ≤3.9 millimole per liter (mmol/L), or repeated asymptomatic hypoglycemia associated with blood glucose \<3.0 mmol/L. Success is defined as lacking of failure., Baseline to last participant visit (up to 72 weeks) | Secondary: Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy, Baseline to last participant visit (up to 72 weeks)|Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia, Baseline to last participant visit (up to 72 weeks)|Change From Baseline of Urinary Albumin to Creatinine Ratio, The Urinary Albumin to Creatinine Ratio is used in addition to Estimated Glomerular Filtration Rate (eGFR) to measure the incidence and progression of diabetic kidney disease., Baseline, Week 72|Change From Baseline in Body Mass Index (BMI), Baseline, Week 72|Change From Baseline of Estimated Glomerular Filtration Rate (eGFR), The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease., Baseline, Week 72 | Other: Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score, Baseline, Week 72|Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score, Baseline, Week 72|Change From Baseline in Mini-mental State Examination (MMSE) Score, Baseline, Week 72
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: OLDER_ADULT
Phases: PHASE4
Enrollment: 192
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-02
Completion Date: 2015-10
Results First Posted: 2016-11-23
Last Update Posted: 2019-10-09
Locations: Suncoast Research Group, LLC, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33175, United States|Suncoast Clinical Research, New Port Richey, Florida, 34652, United States|Florida Hospital, Orlando, Florida, 32804, United States|Athens Primary Care, Athens, Georgia, 30606, United States|Herman Clinical Research, LLC, Suwanee, Georgia, 30024, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Iderc, P.L.C., Des Moines, Iowa, 50314, United States|Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States|Mercy Health Research, Saint Louis, Missouri, 63141, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|Heritage Valley Medical Group, Inc., Beaver, Pennsylvania, 15009, United States|Family Medical Associates, Levittown, Pennsylvania, 19056, United States|Carolina Health Specialists, Myrtle Beach, South Carolina, 29572, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Rockwood Clinic Research Center, Spokane, Washington, 99202, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saint Stefan Ob Stainz, A-8511, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Salzburg, 5026, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Vienna, A-1060, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wien, A 1210, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Berlin, 10409, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dortmund, 44137, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Hamburg, 22607, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mainz, 55116, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Münster, 48145, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Neuwied, 56564, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Stuttgart, 70378, Germany|Manati Medical Center, Manati, 00674, Puerto Rico|American Telemedicine Center, San Juan, 00917-3104, Puerto Rico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Salford, Manchester, M6 8HD, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dundee, Scotland, DD1 9SY, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sheffield, South Yorkshire, S5 7AU, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ipswich, Suffolk, IP4 5PD, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Manchester, M41 5SL, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02072096

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details
D336 Pioglitazone small molecule DB01132 Details