Clinical trial NCT02072096: A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)
Official title: An Individualized treatMent aPproach for oldER patIents: A Randomized, Controlled stUdy in Type 2 Diabetes Mellitus (IMPERIUM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 192
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the benefits and risks associated with the use of 2 treatment strategies to lower blood sugar in participants aged 65 and older with T2DM. One strategy is based on the use of oral and injectable medications that only reduce blood sugar (glucose) when it is high. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.


Eligibility criteria: Inclusion Criteria:

* Have T2DM based on a history and clinical impression that is consistent with the World Health Organization (WHO) Classification of Diabetes
* Have a Clinical Frailty Scale (CFS) score of 4 or above or Total Illness Burden Index (TIBI) score of 5 or above as assessed at screening
* Have an A1c \>7.3% and \<10.9% at study entry and are not achieving desired glycemic control as evidenced by A1c measurement at least 0.4% higher than individualized treatment target set at screening.
* Have been treated for at least 3 months prior to the study entry with any of the following treatment options:

  * Diet/exercise only (only if they have known contraindications to metformin treatment)
  * Any dose of sulfonylurea
  * Effective or maximally-tolerated doses of metformin, dipeptidyl-peptidase-4 (DPP-4) inhibitor, thiazolidinedione, or acarbose used in monotherapy or in dual combination. The following doses are considered to be effective:

    * at least 1500 mg of metformin per day
    * At least 30 mg of pioglitazone per day
    * At least 4 mg of rosiglitazone per day
    * At least 75 mg of acarbose per day
    * Any marketed dose of DPP-4 inhibitor

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the investigational product used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 60 days in a clinical trial involving an investigational product other than the investigational product used in this study. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have previously completed or withdrawn from this study. This exclusion criterion does not apply to participants who are rescreened prior to randomization
* At study entry, have contraindications to sulfonylurea, insulin, or GLP-1 RA
* Have a history of pancreatitis, a personal or family history of medullary thyroid carcinoma, or have Multiple Endocrine Neoplasia syndrome type 2
* Have taken any injectable glucose-lowering agent, miglitol, meglitinide, Sodium/Glucose cotransporter-2 inhibitor, or other antihyperglycemia treatment that is not listed in the fourth inclusion criterion for more than 10 days within 3 months prior to the study entry
* In the opinion of investigator should have an individualized A1c target set at 8% or higher
* Have a body mass index (BMI) greater than 45 kg/m\^2
* Have had more than 1 episode of severe hypoglycemia within 24 weeks prior to the study
* Have cardiac disease with functional status that is Class III or IV according to the New York Heart Association Cardiac Disease Classification
* Have an estimated glomerular filtration rate (eGFR) \<30 milliliter/minute/1.73 m\^2 (mL/min/1.73 m\^2) or advanced renal disease including history of renal transplantation or currently receiving renal dialysis
* Have obvious clinical signs or symptoms or laboratory evidence of liver disease (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 2.5 times the upper limit of the reference range)
* Receive current therapy for a malignancy, other than basal-cell or squamous-cell skin cancer
* Received systemic glucocorticoids within the 3 months prior to entry for more than 14 consecutive days
* Have any other condition that precludes the participant from following and completing the study

Primary outcomes:
measure: Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia
timeFrame: Baseline to last participant visit (up to 72 weeks)
Secondary outcomes:
measure: Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy
timeFrame: Baseline to last participant visit (up to 72 weeks)
measure: Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
timeFrame: Baseline to last participant visit (up to 72 weeks)
measure: Change From Baseline of Urinary Albumin to Creatinine Ratio
timeFrame: Baseline, Week 72
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Baseline, Week 72
Other outcomes:
measure: Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score
timeFrame: Baseline, Week 72
measure: Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score
timeFrame: Baseline, Week 72
measure: Change From Baseline in Mini-mental State Examination (MMSE) Score
timeFrame: Baseline, Week 72
Locations:
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Athens
country: United States
facility: Athens Primary Care
state: Georgia
city: Suwanee
country: United States
facility: Herman Clinical Research, LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: Beaver
country: United States
facility: Heritage Valley Medical Group, Inc.
state: Pennsylvania
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Health Specialists
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: Spokane
country: United States
facility: Rockwood Clinic Research Center
state: Washington
city: Saint Stefan Ob Stainz
country: Austria
facility: 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.
city: Salzburg
country: Austria
facility: 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.
city: Vienna
country: Austria
facility: 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.
city: Wien
country: Austria
facility: 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.
city: Berlin
country: Germany
facility: 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.
city: Dortmund
country: Germany
facility: 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.
city: Hamburg
country: Germany
facility: 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.
city: Mainz
country: Germany
facility: 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.
city: Münster
country: Germany
facility: 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.
city: Neuwied
country: Germany
facility: 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.
city: Stuttgart
country: Germany
facility: 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.
city: Manati
country: Puerto Rico
facility: Manati Medical Center
city: San Juan
country: Puerto Rico
facility: American Telemedicine Center
city: Salford
country: United Kingdom
facility: 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.
state: Manchester
city: Dundee
country: United Kingdom
facility: 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.
state: Scotland
city: Sheffield
country: United Kingdom
facility: 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.
state: South Yorkshire
city: Ipswich
country: United Kingdom
facility: 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.
state: Suffolk
city: Manchester
country: United Kingdom
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Heller SR, Pratley RE, Sinclair A, Festa A, Kiljanski J, Brusko CS, Duan R, Heine RJ. Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM). Diabetes Obes Metab. 2018 Jan;20(1):148-156. doi: 10.1111/dom.13051. Epub 2017 Aug 8.