A Comparison of Two Treatment Strategies in Older Participants With Type 2 Diabetes Mellitus (T2DM) (IMPERIUM)
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| ClinicalTrials.gov Identifier: NCT02072096 |
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Recruitment Status :
Terminated
(The trial was terminated per protocol because of lack of feasibility.)
First Posted : February 26, 2014
Results First Posted : November 23, 2016
Last Update Posted : October 9, 2019
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Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus, Type 2 | 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 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 192 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Individualized treatMent aPproach for oldER patIents: A Randomized, Controlled stUdy in Type 2 Diabetes Mellitus (IMPERIUM) |
| Study Start Date : | February 2014 |
| Actual Primary Completion Date : | October 2015 |
| Actual Study Completion Date : | October 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Drug: Metformin
Administered orally Drug: Pioglitazone Administered orally Drug: Acarbose Administered orally Drug: Linagliptin Administered orally Drug: Sitagliptin Administered orally Drug: Liraglutide Administered subcutaneously (SC) Drug: Exenatide once weekly (QW) Administered SC Drug: Exenatide twice daily (BID) Administered SC |
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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. Insulin glargine is titrated according treatment algorithm. Treatment may last up to 72 weeks.
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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: Insulin Glargine Administered SC |
Primary Outcome Measures :
- 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) ]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.
Secondary Outcome Measures :
- 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) ]
- Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia [ Time Frame: Baseline to last participant visit (up to 72 weeks) ]
- Change From Baseline of Urinary Albumin to Creatinine Ratio [ Time Frame: Baseline, Week 72 ]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.
- Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 72 ]
- Change From Baseline of Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline, Week 72 ]The eGFR is used in addition to the Urinary Albumin to Creatinine Ratio to measure the incidence and progression of diabetic kidney disease.
Other Outcome Measures:
- Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score [ Time Frame: Baseline, Week 72 ]
- Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score [ Time Frame: Baseline, Week 72 ]
- Change From Baseline in Mini-mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 72 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072096
Locations
Show 34 study locations
Sponsors and Collaborators
Eli Lilly and Company
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT02072096 |
| Other Study ID Numbers: |
14842 F3Z-MC-IOQL ( Other Identifier: Eli Lilly and Company ) 2013-001473-24 ( EudraCT Number ) |
| First Posted: | February 26, 2014 Key Record Dates |
| Results First Posted: | November 23, 2016 |
| Last Update Posted: | October 9, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
| Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
| URL: | https://vivli.org/ |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Metformin Insulin Glargine Pioglitazone Sitagliptin Phosphate Liraglutide Exenatide Glimepiride Linagliptin Acarbose |
Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Obesity Agents Anti-Arrhythmia Agents Immunosuppressive Agents Immunologic Factors Glycoside Hydrolase Inhibitors |