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Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

Assessment of Dose-Dependent Effects of LY2189265 on Glycemic Control in Patients With Type 2 Diabetes Treated Only With Lifestyle Interventions

NCT00791479•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type 2 diabetes mellitus.

Detailed Description

Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram \[mg\]) or placebo. The main purpose is to assess dose-dependent effect of this new compound on blood glucose over a period of 12 weeks. Therefore, glycosylated hemoglobin (HbA1c) is chosen as the primary efficacy measure. Several other attributes of glycemic control and endocrine function of pancreas will be assessed as secondary objectives. These secondary objectives will be used to compare the effect of the experimental compound and placebo. Since LY2189265 is in early phase of development, comprehensive safety assessment is planned to learn more about possible side-effects and to establish benefit/risk profile of individual doses of the drug. The trial is organized in four phases: screening, lead-in period to establish baseline status of participants in each group, treatment period during which participants will be randomized into 1 of 5 groups (4 will receive one of the LY2189265 doses, 1 group will receive placebo), and safety follow up. Maximum of 9 study visits are planned. Study drug (LY2189265 or placebo) will be administered once weekly via subcutaneous (SC) injections. Rescue intervention was allowed after randomization for those participants whose hyperglycemia reached pre-defined unacceptable high values. Participants on rescue therapy remained in the study and continued to receive study drug. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses. A 3-mg LY2189265 dose was discontinued and replaced with the 1.5 mg dose based on dose finding Study H9X-MC-GBCF; NCT00734474. Except where noted, data summaries from the 3 discontinued 3-mg LY2189265 participants (n=3) are not included due to the small number of participants and the short treatment duration.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diabetes mellitus, type 2
•Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
•Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
•Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy \>6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
•Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
•Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m\^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m\^2, inclusive.
•Stable weight for 3 months prior to screening

Exclusion Criteria

•Diabetes mellitus, type 1
•Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
•Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
•Use of medications (prescription or over-the counter) to promote weight loss
•Chronic (\>2 weeks) use of systemic glucocorticoid therapy
•Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
•Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release \[SR\])
•Cardiovascular event within 6 months prior to screening
•Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
•Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
+14 more criteria

Locations (46)

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.

Concord, California, United States

Lancaster, California, United States

Mission Hills, California, United States

Palm Springs, California, United States

Vincennes, Indiana, United States

Wichita, Kansas, United States

Bloomfield Hills, Michigan, United States

Calabash, North Carolina, United States

Tabor City, North Carolina, United States

Beaver, Pennsylvania, United States

Key Dates

Start Date

December 1, 2008

Primary Completion Date

January 1, 2010

Completion Date

January 1, 2010

Last Updated

December 10, 2014

Enrollment

167

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2189265 and Lifestyle Measures

DRUG

Placebo solution and Lifestyle Measures

DRUG

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

NCT06959901

Obesity and Diabetes Mellitus, Type 2Diabetes Prevention

View study

RECRUITINGNA

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

NCT06574035

Diabetes Mellitus, Type 2Depressive Symptoms+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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