Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01468181Other id13991Other idH9X-JE-GBDQ

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 394 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
Japan
Start: Nov 2011
Primary completion: Dec 2013
Completion: Dec 2013
First posted: 9 Nov 2011 (estimated)
Last update posted: 29 Jan 2015 (estimated)
Conditions: Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2011201220132014

Ph 3
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
NCT01468181
Nov 2011 to Dec 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as 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).

Interventions

LY2189265Drug
Sulfonylureas (SU)Drug
Biguanides (BG)Drug
alpha-glucosidase inhibitor (a-GI)Drug
Thiazolidinedione (TZD)Drug
GlinidesDrug

Arms5

Experimental
LY2189265 + Sulfonylureas (SU)
LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.
Experimental
LY2189265 + Biguanides (BG)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.
Experimental
LY2189265 + alpha-glucosidase inhibitor (a-GI)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.
Experimental
LY2189265 + Thiazolidinedione (TZD)
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.
Experimental
LY2189265 + Glinides
LY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.

Primary outcomes2

Outcomes the sponsor listed as primary.

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame · Baseline through 52 Weeks
Registry description
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
Time frame · Baseline through 52 Weeks
Registry description
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.

Secondary outcomes(6)

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)
Time frame · Baseline, up to 26 weeks and up to 52 weeks
Registry description
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.
Change From Baseline in Body Weight
Time frame · Baseline, up to 26 weeks and up to 52 weeks
Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)
Time frame · Baseline, up to 26 weeks and up to 52 weeks
Registry description
The HOMA2 is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady state pancreatic beta cell function (%B) and to estimate insulin sensitivity (%S) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100%. The change from baseline for fasting insulin concentrations are presented as insulin secretion (HOMA2-%B) and insulin sensitivity (HOMA2-%S).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline through 52 Weeks

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

Group	Value (percentage of participants)
LY2189265 + SU	85.5
LY2189265 + BG	83.6
LY2189265 + a-GI	70.8
LY2189265 + TZD	80.3
LY2189265 + Glinides	73.2

Primary outcomeNumber· Baseline through 52 Weeks

Percentage of Participants With Hypoglycemic Episodes

Group	Value (percentage of participants)
LY2189265 + SU	33.6
LY2189265 + BG	3.3
LY2189265 + a-GI	6.2
LY2189265 + TZD	6.1
LY2189265 + Glinides	9.9

Secondary and other outcome results(6)

Secondary outcomeMean· Baseline, up to 26 Weeks and up to 52 Weeks

Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Group	Value (percentage of HbA1c)	Spread
LY2189265 + SU	-1.93	0.09
LY2189265 + BG	-1.58	0.11
LY2189265 + a-GI	-1.67	0.10
LY2189265 + TZD	-1.71	0.13
LY2189265 + Glinides	-1.80	0.12

Secondary outcomeNumber· 26 weeks and 52 weeks

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

Group	Value (percentage of participants)
LY2189265 + SU	35.1
LY2189265 + BG	54.1
LY2189265 + a-GI	72.3
LY2189265 + TZD	60.6
LY2189265 + Glinides	53.5

Secondary outcomeMean· Baseline, up to 26 weeks and up to 52 weeks

Change From Baseline in Fasting Blood Glucose (FBG)

Group	Value (milligrams/deciliters (mg/dL))	Spread
LY2189265 + SU	-46.8	4.2
LY2189265 + BG	-37.9	4.0
LY2189265 + a-GI	-46.8	4.7
LY2189265 + TZD	-42.1	4.5
LY2189265 + Glinides	-42.7	3.9

Secondary outcomeMean· Baseline, up to 26 weeks and up to 52 weeks

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

Group	Value (mg/dL)	Spread
LY2189265 + SU	-44.70	4.57
LY2189265 + BG	-34.60	3.88
LY2189265 + a-GI	-45.97	4.99
LY2189265 + TZD	-35.40	3.85
LY2189265 + Glinides	-48.26	4.33

Secondary outcomeMean· Baseline, up to 26 weeks and up to 52 weeks

Change From Baseline in Body Weight

Group	Value (kilograms (kg))	Spread
LY2189265 + SU	0.02	0.22
LY2189265 + BG	-0.74	0.39
LY2189265 + a-GI	-1.22	0.33
LY2189265 + TZD	0.78	0.30
LY2189265 + Glinides	0.19	0.25

Secondary outcomeMean· Baseline, up to 26 weeks and up to 52 weeks

Change From Baseline in Updated Homeostasis Model Assessment (HOMA2)

Group	Value (percentage of HOMA2)	Spread
LY2189265 + SU	29.10	2.75
LY2189265 + BG	28.15	2.79
LY2189265 + a-GI	30.88	3.25
LY2189265 + TZD	27.34	2.60
LY2189265 + Glinides	26.93	2.59

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LY2189265 + SULY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study.	–	9 / 131	112 / 131
LY2189265 + BGLY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study.	–	3 / 61	51 / 61
LY2189265 + a-GILY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study.	–	4 / 65	46 / 65
LY2189265 + TZDLY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study.	–	1 / 66	53 / 66
LY2189265 + GlinidesLY2189265: 0.75 mg administered SC, once weekly for 52 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study.	–	3 / 71	52 / 71

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 20 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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