A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

Eli Lilly and Company394 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

394

Conditions

Type 2 Diabetes Mellitus

Interventions

LY2189265DRUG

Sulfonylureas (SU)DRUG

SU is a pre-study prescribed dose and is not being provided as part of the trial.

Biguanides (BG)DRUG

Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus before screening * Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening * Participants must have a qualifying HbA1c value of 7.0% to 11.0% at screening * Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Participants who have a diagnosis of type 1 diabetes * Participants who have previously been treated with any other glucagon-like peptide-1 (GLP-1) analog within the 3 months before screening * Participants who are currently taking insulin or have had previous insulin treatment within the 3 months before screening * Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥3 times the upper limit of the reference range and/or a serum lipase concentration ≥2 times the upper limit of the reference range, as determined by the central laboratory at screening * Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)

Locations (14)

Outcomes

Primary Outcomes

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

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.

Time frame: Baseline through 52 Weeks

Percentage of Participants With Hypoglycemic Episodes

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.

Time frame: Baseline through 52 Weeks

Secondary Outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline, up to 26 Weeks and up to 52 Weeks

Percentage of Participants Who Achieve HbA1c ≤6.5% or <7%

Time frame: 26 weeks and 52 weeks

Change From Baseline in Fasting Blood Glucose (FBG)

Time frame: Baseline, up to 26 weeks and up to 52 weeks

Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG)

Participants were to test and record SMBG concentrations in their study diaries before each meal (breakfast, lunch, and dinner), approximately 2 hours after the start of each meal. For the mean of all 7-point blood glucose values, the daily mean was calculated as the average of 7 blood glucose values collected on a particular day. The mean of all 7-point blood glucose values at each visit was calculated as the average of 2 daily means. The change from baseline was calculated as the mean of all 7-point blood glucose values at endpoint minus the mean of all 7-point blood glucose values at baseline.

Data from ClinicalTrials.gov

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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.

Aichi, Japan

Chiba, Japan

Hokkaido, Japan

Hyōgo, Japan

Ibaraki, Japan

Kanagawa, Japan

Kyoto, Japan

Nagano, Japan

Okayama, Japan

Osaka, Japan

...and 4 more locations