A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	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)
Phase	Phase 4
Sponsor	Eli Lilly and Company
Responsible Party	Eli Lilly and Company
ClinicalTrials.gov Identifier	NCT02072096
First Received	February 24, 2014
Last Updated	April 21, 2014
Last verified	April 2014

Tracking Information[ + expand ][ + ]

First Received Date	February 24, 2014
Last Updated Date	April 21, 2014
Start Date	February 2014
Estimated Primary Completion Date	April 2018
Current Primary Outcome Measures	Proportion of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (A1c) Targets Without Clinically Significant Hypoglycemia [Time Frame: Baseline through 72 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures	Proportion of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy [Time Frame: Baseline through 72 weeks] [Designated as safety issue: No] Incidence of Total Hypoglycemia and Other Categories of Hypoglycemia [Time Frame: Baseline through 72 weeks] [Designated as safety issue: Yes] Change from Baseline of Urinary Albumin to Creatinine Ratio [Time Frame: Baseline through 72 weeks] [Designated as safety issue: Yes] Change from Baseline in Body Mass Index (BMI) [Time Frame: Baseline through 72 weeks] [Designated as safety issue: Yes] Change from Baseline of Estimated Glomerular Filtration Rate (eGFR) [Time Frame: Baseline through 72 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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)
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Glimepiride Administered orally Drug: Metformin Administered orally Drug: Pioglitazone Administered orally Drug: Acarbose Administered orally Drug: Linagliptin Administered orally Drug: Sitagliptin Administered orally Drug: Liraglutide Administered orally Drug: Insulin Glargine Administered subcutaneously (SQ) Drug: Exenatide once weekly (QW) Administered SQ Drug: Exenatide twice daily (BID) Administered SQ
Study Arm (s)	Experimental: Strategy A (Glucose-Dependent) Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks. Active Comparator: Strategy B (Reference) Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	880
Estimated Completion Date	April 2018
Estimated Primary Completion Date	April 2018
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 advance 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
Gender	Both
Ages	65 Years
Accepts Healthy Volunteers	No
Contacts	Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Location Countries	United States, Austria, Germany, Puerto Rico, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT02072096
Other Study ID Numbers	14842
Has Data Monitoring Committee	No
Information Provided By	Eli Lilly and Company
Study Sponsor	Eli Lilly and Company
Collaborators	Not Provided
Investigators	Study Director: 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) Eli Lilly and Company
Verification Date	April 2014

Locations[ + expand ][ + ]

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.	Concord, California, United States, 94520 Contact: Eli Lilly Not yet recruiting
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.	Miami, Florida, United States, 33175 Contact: Eli Lilly Recruiting
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.	New Port Richey, Florida, United States, 34652 Contact: Eli Lilly Recruiting
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.	Orlando, Florida, United States, 32804 Contact: Eli Lilly Not yet recruiting
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.	Suwanee, Georgia, United States, 30024 Contact: Eli Lilly Recruiting
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.	Idaho Falls, Idaho, United States, 83404 Contact: Eli Lilly Recruiting
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.	Des Moines, Iowa, United States, 50314 Contact: Eli Lilly Recruiting
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.	Topeka, Kansas, United States, 66606 Contact: Eli Lilly Recruiting
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.	Minneapolis, Minnesota, United States, 55416 Contact: Eli Lilly Not yet recruiting
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.	St Louis, Missouri, United States, 63141 Contact: Eli Lilly Recruiting
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.	Las Vegas, Nevada, United States, 89148 Contact: Eli Lilly Recruiting
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.	Nashua, New Hampshire, United States, 03063 Contact: Eli Lilly Recruiting
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.	Syracuse, New York, United States, 13210 Contact: Eli Lilly Recruiting
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.	Myrtle Beach, South Carolina, United States, 29572 Contact: Eli Lilly Recruiting
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.	Dallas, Texas, United States, 75230 Contact: Eli Lilly Recruiting
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.	El Paso, Texas, United States, 79925 Contact: Eli Lilly Recruiting
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.	San Antonio, Texas, United States, 78229 Contact: Eli Lilly Recruiting
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.	Spokane, Washington, United States, 99202 Contact: Eli Lilly Recruiting
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, Austria, 5026 Contact: Eli Lilly Recruiting
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.	St. Stefan Ob Stainz, Austria, A-8511 Contact: Eli Lilly Recruiting
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, Austria, A 1210 Contact: Eli Lilly Recruiting
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.	Aschaffenburg, Germany, 63739 Contact: Eli Lilly Recruiting
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, Germany, 10409 Contact: Eli Lilly Recruiting
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, Germany, 44137 Contact: Eli Lilly Recruiting
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, Germany, 22607 Contact: Eli Lilly Recruiting
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, Germany, 55116 Contact: Eli Lilly Recruiting
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, Germany, 48145 Contact: Eli Lilly Recruiting
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, Germany, 56564 Contact: Eli Lilly Recruiting
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, Germany, 70378 Contact: Eli Lilly Recruiting
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.	Manati, Puerto Rico, 00674 Contact: Eli Lilly Recruiting
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.	San Juan, Puerto Rico, 00917-3104 Contact: Eli Lilly Recruiting
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, United Kingdom, M6 8HD Contact: Eli Lilly Recruiting
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, United Kingdom, DD1 9SY Contact: Eli Lilly Recruiting
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, United Kingdom, S5 7AU Contact: Eli Lilly Recruiting
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, United Kingdom, IP4 5PD Contact: Eli Lilly Recruiting
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, United Kingdom, M41 5SL Contact: Eli Lilly Recruiting

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A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM)

Overview[ - collapse ][ - ]

Tracking Information[ + expand ][ + ]

Descriptive Information[ + expand ][ + ]

Recruitment Information[ + expand ][ + ]

Administrative Information[ + expand ][ + ]

Locations[ + expand ][ + ]