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IMPERIUM

TerminatedPhase 4Results posted

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

An Individualized treatMent aPproach for oldER patIents: A Randomized, Controlled stUdy in Type 2 Diabetes Mellitus (IMPERIUM)

Lead sponsor

Eli Lilly and Company

Assets

Exenatide / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

192

actual

Study population

Type 2 diabetes

Key I/E criteria

•HbA1c 7.3-10.9%•Age ≥65

Primary endpoint

•And Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02072096

Org study ID14842

Secondary ID2013-001473-24

Secondary IDF3Z-MC-IOQLEli Lilly and Company

Timeline

Milestones

Study first posted2014-02-26estimated

Results first posted2016-11-23estimated

Last update posted2019-10-09actual

Study start2014-02 (month precision)

Primary completion2015-10actual (month precision)

Study completion2015-10actual (month precision)

Assets

Investigational agents

Exenatide Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Renal / kidney

Patient-reported / QoL

Weight & body composition

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kilogram per square meter (kg/m^2)	95% CI
Strategy A (Glucose-Dependent)	-0.47	—
Strategy B (Reference)	0.20	—

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/registry result

Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia

Time frame:Baseline to last participant visit (up to 72 weeks)

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
Strategy A (Glucose-Dependent)	64.5	54.4 – 73.4
Strategy B (Reference)	54.9	44.6 – 64.9

Primary/protocol endpoint/low confidence

Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia

Time frame:Baseline to last participant visit (up to 72 weeks)

threshold achievement, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy

Time frame:Baseline to last participant visit (up to 72 weeks)

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Strategy A (Glucose-Dependent)	21	—
Strategy B (Reference)	13	—

Secondary/protocol endpoint

Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy

Time frame:Baseline to last participant visit (up to 72 weeks)

threshold achievement, event

Renal / kidney

4 endpoints

Secondary/registry result

Change From Baseline of Urinary Albumin to Creatinine Ratio

Time frame:Baseline, Week 72

uACR, change

change from baseline, improvement

LOINC 9318-7

Posted result

Group	Value (mean), milligram per millimole (mg/mmol)	95% CI
Strategy A (Glucose-Dependent)	1.85	—
Strategy B (Reference)	1.85	—

Secondary/registry result

Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, Week 72

eGFR, change

change from baseline, improvement

LOINC 98979-8

Posted result

Group	Value (mean), milliliter per minute/1.73 square meter	95% CI
Strategy A (Glucose-Dependent)	-5.00	—
Strategy B (Reference)	-5.88	—

Secondary/protocol endpoint

Change From Baseline of Urinary Albumin to Creatinine Ratio

Time frame:Baseline, Week 72

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint

Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, Week 72

eGFR, change

change from baseline, improvement

LOINC 98979-8

Patient-reported / QoL

4 endpoints

Other/protocol endpoint

Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score

Time frame:Baseline, Week 72

change from baseline, improvement

Other/protocol endpoint

Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score

Time frame:Baseline, Week 72

EQ-5D index

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score

Time frame:Baseline, Week 72

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score

Time frame:Baseline, Week 72

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/registry result

Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia

Time frame:Baseline to last participant visit (up to 72 weeks)

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), Participants	95% CI
Strategy A (Glucose-Dependent)Total Hypoglycemia	10	—
Severe Hypoglycemia	0	—
Clinically Significant Hypoglycemia	0	—
Symptomatic Hypoglycemia	5	—
Asymptomatic Hypoglycemia	8	—
Probable Symptomatic Hypoglycemia	0	—
Unspecified Hypoglycemia	2	—
Relative Hypoglycemia	1	—
Nocturnal Hypoglycemia	4	—
Strategy B (Reference)Total Hypoglycemia	50	—
Severe Hypoglycemia	0	—
Clinically Significant Hypoglycemia	1	—
Symptomatic Hypoglycemia	34	—
Asymptomatic Hypoglycemia	30	—
Probable Symptomatic Hypoglycemia	7	—
Unspecified Hypoglycemia	7	—
Relative Hypoglycemia	6	—
Nocturnal Hypoglycemia	10	—

Secondary/protocol endpoint

Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia

Time frame:Baseline to last participant visit (up to 72 weeks)

Documented hypoglycemia

event count, event

Other clinical outcomes

2 endpoints

Other/protocol endpoint

Change From Baseline in Mini-mental State Examination (MMSE) Score

Time frame:Baseline, Week 72

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change From Baseline in Mini-mental State Examination (MMSE) Score

Time frame:Baseline, Week 72

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM).
Diabetes, obesity & metabolism2018 Jan (month)PMID28671753doi:10.1111/dom.13051via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.