Who is sponsoring NCT01468181?

NCT01468181 is sponsored by Eli Lilly and Company.

What condition does NCT01468181 study?

NCT01468181 studies Type 2 Diabetes Mellitus.

What drugs are being tested in NCT01468181?

Interventions: LY2189265, Sulfonylureas (SU), Biguanides (BG), alpha-glucosidase inhibitor (a-GI), Thiazolidinedione (TZD), Glinides.

What is the status of NCT01468181?

NCT01468181 is currently COMPLETED.

Last reviewed 2015-01-16 · How we verify

A 52-Week, Open-Label, Long-Term Safety Study of LY2189265 in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus

NCT01468181 Phase 3 COMPLETED Results posted

This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	COMPLETED
Enrolment	394
Start date	2011-11
Completion	2013-12

Conditions

Type 2 Diabetes Mellitus

Interventions

LY2189265
Sulfonylureas (SU)
Biguanides (BG)
alpha-glucosidase inhibitor (a-GI)
Thiazolidinedione (TZD)
Glinides

Primary outcomes

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — Baseline through 52 Weeks
A TEAE was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants With Hypoglycemic Episodes — Baseline through 52 Weeks
The percentage of participants with hypoglycemic episodes was calculated by dividing the number of participants with at least 1 hypoglycemic episode over the 52-week treatment period by the total number of participants analyzed, multiplied by 100%. All classifications of hypoglycemia (documented symptomatic, asymptomatic, severe, nocturnal, non-nocturnal, probable symptomatic, relative, and unspecified) were included, except for episodes of relative hypoglycemia that were not severe. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.

Countries

Japan