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

Diabetes Mellitus, Type 2 Clinical Trial

— IMPERIUM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02072096
• Other study ID #: 14842
• Secondary ID: F3Z-MC-IOQL2013-
• Status: Terminated
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The other strategy is based on non-glucose dependent agents. The trial will last up to 72 weeks for each participant.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 192
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Glimepiride
Administered orally
• Metformin
Administered orally
• Pioglitazone
Administered orally
• Acarbose
Administered orally
• Linagliptin
Administered orally
• Sitagliptin
Administered orally
• Liraglutide
Administered subcutaneously (SC)
• Insulin Glargine
Administered SC
• Exenatide once weekly (QW)
Administered SC
• Exenatide twice daily (BID)
Administered SC

Locations

Country	Name	City	State
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.	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.	Wien
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.	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
Puerto Rico	Manati Medical Center	Manati
Puerto Rico	American Telemedicine Center	San Juan
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.	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	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.	Sheffield	South Yorkshire
United States	Athens Primary Care	Athens	Georgia
United States	Heritage Valley Medical Group, Inc.	Beaver	Pennsylvania
United States	Dallas Diabetes Endocrine Center	Dallas	Texas
United States	Iderc, P.L.C.	Des Moines	Iowa
United States	Rocky Mountain Diabetes and Osteoporosis Center	Idaho Falls	Idaho
United States	Family Medical Associates	Levittown	Pennsylvania
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Southern New Hampshire Diabetes and Endocrinology	Nashua	New Hampshire
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Florida Hospital	Orlando	Florida
United States	Mercy Health Research	Saint Louis	Missouri
United States	Rockwood Clinic Research Center	Spokane	Washington
United States	Herman Clinical Research, LLC	Suwanee	Georgia
United States	Cotton O'Neil Clinic	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Austria,  Germany,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score		Baseline, Week 72
Other	Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score		Baseline, Week 72
Other	Change From Baseline in Mini-mental State Examination (MMSE) Score		Baseline, Week 72
Primary	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.	Baseline to last participant visit (up to 72 weeks)
Secondary	Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy		Baseline to last participant visit (up to 72 weeks)
Secondary	Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia		Baseline to last participant visit (up to 72 weeks)
Secondary	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.	Baseline, Week 72
Secondary	Change From Baseline in Body Mass Index (BMI)		Baseline, Week 72
Secondary	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.	Baseline, Week 72