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

NCT ID: NCT02072096

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-10-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Strategy A (Glucose-Dependent)

Participants may receive oral and injectable (glucagon-like peptide-1 receptor agonists \[GLP-1 RA\]) therapies 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. Treatment may last up to 72 weeks.

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Administered orally

Pioglitazone

Intervention Type: DRUG

Administered orally

Acarbose

Intervention Type: DRUG

Administered orally

Linagliptin

Intervention Type: DRUG

Administered orally

Sitagliptin

Intervention Type: DRUG

Administered orally

Liraglutide

Intervention Type: DRUG

Administered subcutaneously (SC)

Exenatide once weekly (QW)

Intervention Type: DRUG

Administered SC

Exenatide twice daily (BID)

Intervention Type: DRUG

Administered SC

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. Insulin glargine is titrated according treatment algorithm. Treatment may last up to 72 weeks.

Group Type: ACTIVE_COMPARATOR

Glimepiride

Intervention Type: DRUG

Administered orally

Metformin

Intervention Type: DRUG

Administered orally

Pioglitazone

Intervention Type: DRUG

Administered orally

Acarbose

Intervention Type: DRUG

Administered orally

Linagliptin

Intervention Type: DRUG

Administered orally

Sitagliptin

Intervention Type: DRUG

Administered orally

Insulin Glargine

Intervention Type: DRUG

Administered SC

Interventions

Glimepiride

Administered orally

Intervention Type: DRUG

Metformin

Administered orally

Intervention Type: DRUG

Pioglitazone

Administered orally

Intervention Type: DRUG

Acarbose

Administered orally

Intervention Type: DRUG

Linagliptin

Administered orally

Intervention Type: DRUG

Sitagliptin

Administered orally

Intervention Type: DRUG

Liraglutide

Administered subcutaneously (SC)

Intervention Type: DRUG

Insulin Glargine

Administered SC

Intervention Type: DRUG

Exenatide once weekly (QW)

Administered SC

Intervention Type: DRUG

Exenatide twice daily (BID)

Administered SC

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Suncoast Research Group, LLC

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Suncoast Clinical Research

New Port Richey, Florida, United States

Florida Hospital

Orlando, Florida, United States

Athens Primary Care

Athens, Georgia, United States

Herman Clinical Research, LLC

Suwanee, Georgia, United States

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

Iderc, P.L.C.

Des Moines, Iowa, United States

Cotton O'Neil Clinic

Topeka, Kansas, United States

Mercy Health Research

St Louis, Missouri, United States

Southern New Hampshire Diabetes and Endocrinology

Nashua, New Hampshire, United States

Heritage Valley Medical Group, Inc.

Beaver, Pennsylvania, United States

Family Medical Associates

Levittown, Pennsylvania, United States

Carolina Health Specialists

Myrtle Beach, South Carolina, United States

Dallas Diabetes Endocrine Center

Dallas, Texas, United States

Rockwood Clinic Research Center

Spokane, Washington, 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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , 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, , Germany

Manati Medical Center

Manatí, , Puerto Rico

American Telemedicine Center

San Juan, , 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, 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, 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, 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, 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, , United Kingdom

Countries

United States; Austria; Germany; Puerto Rico; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28671753 (View on PubMed)

Other Identifiers

F3Z-MC-IOQL

Identifier Type: OTHER

Identifier Source: secondary_id

2013-001473-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14842

Identifier Type: -

Identifier Source: org_study_id