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Diabetes Mellitus, Type 2Phase 4IMPERIUMNCT02072096

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

A Phase 4 study testing Glimepiride, Metformin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 34 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Glimepiride, Metformin and Pioglitazone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
34 sitesin 5 countries
Study dates
Feb 2014to Oct 2015
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

34 sites in 5 countries.

34 sites in 5 countries

United States16 sites

  • Athens Primary Care

    Athens, Georgia, 30606

  • Heritage Valley Medical Group, Inc.

    Beaver, Pennsylvania, 15009

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • Iderc, P.L.C.

    Des Moines, Iowa, 50314

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • Family Medical Associates

    Levittown, Pennsylvania, 19056

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33175

  • Carolina Health Specialists

    Myrtle Beach, South Carolina, 29572

  • Southern New Hampshire Diabetes and Endocrinology

    Nashua, New Hampshire, 03063

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Florida Hospital

    Orlando, Florida, 32804

  • Rockwood Clinic Research Center

    Spokane, Washington, 99202

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Herman Clinical Research, LLC

    Suwanee, Georgia, 30024

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

Other trials in United States

Germany7 sites

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in Germany

United Kingdom5 sites

  • 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

  • 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

  • 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

  • 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

  • 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

Other trials in United Kingdom

Austria4 sites

  • 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

  • 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

  • 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 1210

  • 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

Other trials in Austria

Puerto Rico2 sites

  • Manati Medical Center

    Manati, 00674

  • American Telemedicine Center

    San Juan, 00917-3104

Other trials in Puerto Rico

About this study

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

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.

Being tested
Glimepiride, Metformin, Pioglitazone, Acarbose, Linagliptin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlimepirideDrug

    Administered orally

  • MetforminDrug

    Administered orally

  • PioglitazoneDrug

    Administered orally

  • AcarboseDrug

    Administered orally

  • LinagliptinDrug

    Administered orally

  • SitagliptinDrug

    Administered orally

  • LiraglutideDrug

    Administered subcutaneously (SC)

  • Insulin GlargineDrug

    Administered SC

  • Exenatide once weekly (QW)Drug

    Administered SC

  • Exenatide twice daily (BID)Drug

    Administered SC

Study groups in NCT02072096
Study groupRoleWhat they receive
Strategy A (Glucose-Dependent)ExperimentalParticipants 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.
Receives: Drug: Metformin; Drug: Pioglitazone; Drug: Acarbose; Drug: Linagliptin; Drug: Sitagliptin; Drug: Liraglutide; Drug: Exenatide once weekly (QW); Drug: Exenatide twice daily (BID)
Strategy B (Reference)Active comparatorParticipants 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.
Receives: Drug: Glimepiride; Drug: Metformin; Drug: Pioglitazone; Drug: Acarbose; Drug: Linagliptin; Drug: Sitagliptin; Drug: Insulin Glargine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to last participant visit (up to 72 weeks)

Secondary outcomes (5)

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

    Measured: Baseline to last participant visit (up to 72 weeks)

  2. Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia

    Measured: Baseline to last participant visit (up to 72 weeks)

  3. 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.

    Measured: Baseline, Week 72

  4. Change From Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 72

  5. 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.

    Measured: Baseline, Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionOct 2015
  4. Study completionOct 2015

Why it stopped: The trial was terminated per protocol because of lack of feasibility.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02072096
Sponsor's protocol ID
14842
Other IDs
F3Z-MC-IOQL, 2013-001473-24
Acronym
IMPERIUM
Status last verified
Sep 2019
First submitted
24 Feb 2014
Last updated
9 Oct 2019
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • 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.

    PubMed 28671753

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glimepiride, Metformin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 34 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Germany, United Kingdom, Austria, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02072096, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.

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