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Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: LY2189265 (Biological); Placebo (Drug); Insulin (Drug); Glucose (Drug); Glucagon (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company


The purpose of this study is to measure the effect of LY2189265 to increase insulin levels in response to glucose intake.

Clinical Details

Official title: The Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose Infusion

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Maximum Insulin Concentration (Cmax) - First Phase Response

Area Under the Insulin Concentration-time Curve (AUC) - First Phase Response

Maximum Insulin Concentration (Cmax) - Second Phase Response

Insulin Area Under the Curve (AUC) - Second Phase Response

Secondary outcome: Insulin Maximum Concentration (Cmax)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria: All Participants

- Women must be surgically sterile (hysterectomy or bilateral oophorectomy or tubal

ligation) or postmenopausal as defined by age >45 years without use of oral contraceptive agents for greater than 1 year and have either:

- spontaneous amenorrhea greater than 12 months, or

- spontaneous amenorrhea 6 to 12 months with documented follicle stimulating

hormone (FSH) >25 milli international units/milliliter (mIU/mL) and serum estradiol <73 picomoles/liter (pmol/L) (20 picograms/milliliter [pg/mL])

- Are reliable and willing to make themselves available for the duration of the study

and are willing to follow study procedures

- Have given written informed consent approved by Lilly and the ethical review board

governing the site

- Have serum creatinine <150 micromoles/liter (µmol/L) (<1. 3 milligrams/deciliter

[mg/dl] in women, <170 µmol/L [<1. 5 mg/dL] in men)

- Have normal hemoglobin result, as determined by the investigator

Healthy Participants

- Overtly healthy men and women as determined by medical history, normal lab results

and physical examination.

- Body mass index (BMI) between 19 and 25 kilograms/meter squared (kg/m^2), inclusive.

- Normal blood pressure and heart rate as determined by the investigator

- Have a normal response to an oral glucose tolerance test (OGTT) (glucose <7. 8

millimoles/liter [mmol/L] [<140 mg/dL] at 2 hours after 75 grams (g) oral glucose load) Participants with type 2 diabetes mellitus (T2DM)

- Participants will have a BMI between 22. 0 and 40. 0 kg/m^2

- Have T2DM controlled with diet and exercise alone or metformin for at least 4 weeks

prior to admission

- Have a hemoglobin A1c (HbA1c) value at screening (or within 4 weeks prior to

screening) of 6. 0% to 9. 5%

- Diagnosed with T2DM within the past 10 years

- Clinical laboratory test results within normal range or deemed clinically

insignificant by the Investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.

- Participants who are taking stable-dose prescription medications (for example,

antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions are permitted to participate providing the medication is not associated with development of torsade de pointes. However, use of beta-blockers and thiazide diuretics are not permitted during this study. Exclusion Criteria: All Participants

- Within 30 days of the initial dose of study drug, have received treatment with a drug

that has not received regulatory approval for any indication

- Known allergies to Glucagon-Like Peptide 1 (GLP-1) related compounds

- Have previously completed or withdrawn from this study or any other study in the last

year investigating glucagon-like peptides or incretin mimetics including exenatide (Byetta®)

- Regular use of known drugs of abuse and/or positive findings on urinary drug

screening, other than findings consistent with medication prescribed by the participant's physician(s)

- History or presence of cardiovascular, respiratory, renal, endocrine (except T2DM),

hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data

- Have a history or presence of gastrointestinal disorder

- Poorly controlled hypertension (systolic greater than 160 millimeters of mercury

[mmHg], diastolic greater than 95 mmHg) and/or evidence of labile blood pressure including symptomatic postural hypotension. Use of beta-blockers or thiazide diuretics is not permitted during the study

- Have a clinically significant history of cardiac disease or presence of active

cardiac disease within 1 year of the screening period

- Evidence of hepatitis C and/or positive hepatitis C antibody

- Evidence of hepatitis B and/or positive hepatitis B surface antigen

- Evidence of human immunodeficiency virus (HIV) and/or positive for HIV antibodies

- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14

units per week (females) or are unwilling to follow alcohol restrictions (1 unit = 12 ounces [oz] or 360 milliliters[mL] of beer; 5 oz or 150 mL of wine; 1. 5 oz or 45 mL of distilled spirits).

- Smoke more than 10 cigarettes or equivalent in nicotine use or nicotine substitutes

per day

- Regular use of systemic corticosteroids by oral, intravenous, or intramuscular route,

or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption

- Have a history or presence of significant active neuropsychiatric disease

- Blood donation of more than 500 mL in the last 3 months or any blood donation within

the last month

- Any other condition, which in the opinion of the investigator would preclude

participation in the study

- An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the

investigator increases the risk of participating in the study.

- Any clinically significant abnormal hematology, clinical chemistry, or urinary

result(s) as determined by the investigator

- Evidence of significant active uncontrolled endocrine or autoimmune abnormalities

(for example thyroid disease, or pernicious anemia) as judged by the screening physician Healthy Participants

- Intended use of over-the-counter or prescription medication 7 and 14 days,

respectively, prior to dosing. Participants with T2DM

- Clinically significant peripheral vascular occlusive disease (PVOD).

- Known severe exudative diabetic retinopathy

- Known significant autonomic neuropathy as evidenced by urinary retention, diabetic

diarrhea, or gastroparesis

- Have experienced a ketoacidotic episode (pH less than 7. 3) requiring hospitalization

in the last 6 months

- Outpatient use of insulin for control of diabetes within the past 2 years

- Use of antidiabetic agents other than metformin in the 4 weeks prior to study entry

or use of thiazolidinediones within 12 weeks of study entry

Locations and Contacts

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., Neuss D-41460, Germany
Additional Information

Starting date: February 2011
Last updated: October 3, 2014

Page last updated: August 23, 2015

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