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

NCT02072096 ↗

Phase 4 Terminated 192 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-02
Primary completion: 2015-10
Completion: 2015-10

Outcome

Missed primary endpoint

Stopped: “The trial was terminated per protocol because of lack of feasibility.”

paper There was no significant difference between Strategy-A and Strategy-B in percentages of patients achieving the primary endpoint (64.5% vs 54.9%; P = .190). PMID 28671753 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Exenatide	Peptide	—	Subcutaneous
Comparator	Glimepiride	Small molecule	—	Oral
Subject	Liraglutide	Peptide	—	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous
Background	Acarbose	Unknown	—	Oral
Background	Linagliptin	Unknown	—	Oral
Background	Metformin	Small molecule	—	Oral
Background	Pioglitazone	Small molecule	—	Oral
Background	Sitagliptin	Small molecule	—	Oral