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A Study of LY2189102 in Patients With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LY2189102

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Type 2 Diabetes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter [ng/ml]), with duration of more than 3 months.
Body mass index between 25 and 40 kilograms per square meter (kg/m2).
Stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks).
Drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator).
Angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria.
Glycated hemoglobin level between 7% and 10%.
Baseline High-sensitivity C-reactive protein greater than or equal to 2 milligrams per liter (mg/L)
Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. Furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug.
Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Exclusion Criteria:

Current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in Inclusion Criteria above).
Current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100 mg per day or less of aspirin allowed).
Within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication.
Presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2.
Evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. A specific assay, (for example, tuberculin testing) will be conducted unless it is medically inappropriate. Exceptions include patients with a history of a positive specific assay for TB who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of TB who have been appropriately treated and can provide documentation.
Symptomatic herpes zoster within 3 months of randomization.
Show evidence of hepatitis C and/or positive hepatitis B surface antigen.
Show evidence of human immunodeficiency virus and/or positive test of antibodies to human immunodeficiency virus (HIV).
Received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study.
Screening serum creatinine greater than 2.0 milligrams per deciliter (mg/dL).
Serum aspartate aminotransferase or alanine aminotransaminase concentration greater than 2x the upper limit of normal.
Known allergies to LY2189102 or excipients.
Previously completed or withdrawn from this study or any other study investigating LY2189102.
Have donated blood of greater than 500 mL within the preceding 30 days and intend to donate within 3 months from the end of study.
Have had other recent or ongoing signs of infection (for example, fever, current treatment with antibiotics).
Experienced a serious bacterial infection within 6 months of randomization.
Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality.
Have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease.
Have had a previous reaction to other biologics that, in the opinion of the investigator, puts the patient at serious risk.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

0.6 milligrams (mg) LY2189102

18 mg LY2189102

180 mg LY2189102

Placebo

Arm Description

0.9% Sodium Chloride

Outcomes

Primary Outcome Measures

Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks

Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.

Secondary Outcome Measures

Change From Baseline in Fasting Glucose at 12 Weeks

Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks

Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks

The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.

Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12

The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.

Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)

The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.

PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)

Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.

Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)

Pharmacokinetics Measured by Serum Concentration at End of Dosing.

Full Information

NCT ID

NCT00942188

First Posted

July 17, 2009

Last Updated

September 6, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00942188

Brief Title

A Study of LY2189102 in Patients With Type 2 Diabetes

Official Title

Phase 2 Randomized, Double-blind, Placebo Controlled, Parallel Design Study in Patients With Type 2 Diabetes Mellitus Who Are Stable on Diet and Exercise, With or Without Metformin Monotherapy.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes

Keywords

Diabetes, Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.6 milligrams (mg) LY2189102

Arm Type

Experimental

Arm Title

18 mg LY2189102

Arm Type

Experimental

Arm Title

180 mg LY2189102

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% Sodium Chloride

Intervention Type

Drug

Intervention Name(s)

LY2189102

Intervention Description

Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received 2 SC injections weekly for 12 weeks.

Primary Outcome Measure Information:

Title

Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Fasting Glucose at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks

Description

Time Frame

Baseline, 12 weeks

Title

Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12

Description

Time Frame

Baseline, week 10, week 12

Title

Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)

Description

Time Frame

Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose

Title

PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)

Description

Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.

Time Frame

Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose

Title

Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)

Description

Pharmacokinetics Measured by Serum Concentration at End of Dosing.

Time Frame

Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter [ng/ml]), with duration of more than 3 months. Body mass index between 25 and 40 kilograms per square meter (kg/m2). Stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks). Drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator). Angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria. Glycated hemoglobin level between 7% and 10%. Baseline High-sensitivity C-reactive protein greater than or equal to 2 milligrams per liter (mg/L) Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. Furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug. Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. Exclusion Criteria: Current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in Inclusion Criteria above). Current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100 mg per day or less of aspirin allowed). Within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication. Presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2. Evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. A specific assay, (for example, tuberculin testing) will be conducted unless it is medically inappropriate. Exceptions include patients with a history of a positive specific assay for TB who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of TB who have been appropriately treated and can provide documentation. Symptomatic herpes zoster within 3 months of randomization. Show evidence of hepatitis C and/or positive hepatitis B surface antigen. Show evidence of human immunodeficiency virus and/or positive test of antibodies to human immunodeficiency virus (HIV). Received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study. Screening serum creatinine greater than 2.0 milligrams per deciliter (mg/dL). Serum aspartate aminotransferase or alanine aminotransaminase concentration greater than 2x the upper limit of normal. Known allergies to LY2189102 or excipients. Previously completed or withdrawn from this study or any other study investigating LY2189102. Have donated blood of greater than 500 mL within the preceding 30 days and intend to donate within 3 months from the end of study. Have had other recent or ongoing signs of infection (for example, fever, current treatment with antibiotics). Experienced a serious bacterial infection within 6 months of randomization. Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality. Have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease. Have had a previous reaction to other biologics that, in the opinion of the investigator, puts the patient at serious risk.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36689

Country

United States

Facility Name

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

Facility Name

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20003

Country

United States

Facility Name

City

Miami Gardens

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48126

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

24912797

Citation

Bihorel S, Fiedler-Kelly J, Ludwig E, Sloan-Lancaster J, Raddad E. Population pharmacokinetic modeling of LY2189102 after multiple intravenous and subcutaneous administrations. AAPS J. 2014 Sep;16(5):1009-17. doi: 10.1208/s12248-014-9623-6. Epub 2014 Jun 11.

Results Reference

derived

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A Study of LY2189102 in Patients With Type 2 Diabetes

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