NCT02072096|TerminatedPhase 4Results

Study Stopped

The trial was terminated per protocol because of lack of feasibility.

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

IMPERIUM

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

Eli Lilly and Company ClinicalTrials.gov

Compare

3 other identifiers

14842F3Z-MC-IOQL2013-001473-24

Study Type

interventional

Target

192

Locations

5 countries

Sites

Timeline

RegisteredFeb 2014

StartedFeb 2014

CompletionOct 2015

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

192

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus-type-2

Timeline

Completed

Started Feb 2014

Geographic Reach

5 countries

34 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

February 1, 2014

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 23, 2016

Completed

Last Updated

October 9, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

February 24, 2014

Results QC Date

October 4, 2016

Last Update Submit

September 25, 2019

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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.
Baseline to last participant visit (up to 72 weeks)

Secondary Outcomes (5)

Percentage of Participants Requiring Alternative Treatment Due to Glycemic Failure of First Line Injectable Therapy
Baseline to last participant visit (up to 72 weeks)
Number of Participants With Total Hypoglycemia and Other Categories of Hypoglycemia
Baseline to last participant visit (up to 72 weeks)
Change From Baseline of Urinary Albumin to Creatinine Ratio
Baseline, Week 72
Change From Baseline in Body Mass Index (BMI)
Baseline, Week 72
Change From Baseline of Estimated Glomerular Filtration Rate (eGFR)
Baseline, Week 72

Other Outcomes (3)

Change From Baseline in Adult Low Blood Sugar Survey (ALBSS) Score
Baseline, Week 72
Change From Baseline in European Quality of Life-5 Dimensions 5 Levels (EQ-5D-5L) Score
Baseline, Week 72
Change From Baseline in Mini-mental State Examination (MMSE) Score
Baseline, Week 72

Study Arms (2)

Strategy A (Glucose-Dependent)

EXPERIMENTAL

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.

Drug: MetforminDrug: PioglitazoneDrug: AcarboseDrug: LinagliptinDrug: SitagliptinDrug: LiraglutideDrug: Exenatide once weekly (QW)Drug: Exenatide twice daily (BID)

Strategy B (Reference)

ACTIVE COMPARATOR

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.

Drug: GlimepirideDrug: MetforminDrug: PioglitazoneDrug: AcarboseDrug: LinagliptinDrug: SitagliptinDrug: Insulin Glargine

Interventions

GlimepirideDRUG

Administered orally

Strategy B (Reference)

MetforminDRUG

Administered orally