Clinical trial NCT00942188: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Diabetes
Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Glucose at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
timeFrame: Baseline, 12 weeks
measure: 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
timeFrame: Baseline, 12 weeks
measure: Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12
timeFrame: Baseline, week 10, week 12
measure: Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)
timeFrame: 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
measure: PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)
timeFrame: 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
measure: Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)
timeFrame: 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
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 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.
state: Alabama
city: Anaheim
country: United States
facility: 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.
state: California
city: Chula Vista
country: United States
facility: 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.
state: California
city: La Mesa
country: United States
facility: 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.
state: California
city: Walnut Creek
country: United States
facility: 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.
state: California
city: Washington
country: United States
facility: 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.
state: District of Columbia
city: Miami Gardens
country: United States
facility: 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.
state: Florida
city: Miami
country: United States
facility: 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.
state: Florida
city: Boise
country: United States
facility: 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.
state: Idaho
city: Baltimore
country: United States
facility: 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.
state: Maryland
city: Dearborn
country: United States
facility: 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.
state: Michigan
city: Philadelphia
country: United States
facility: 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.
state: Pennsylvania
city: Arlington
country: United States
facility: 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.
state: Texas
city: Dallas
country: United States
facility: 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.
state: Texas
city: San Antonio
country: United States
facility: 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.
state: Texas
city: Tomball
country: United States
facility: 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.
state: Texas
city: Salt Lake City
country: United States
facility: 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.
state: Utah
city: Richmond
country: United States
facility: 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.
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.