A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Doses of LY2409021 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01606397
• Other study ID #: 11071
• Secondary ID: I1R-FW-GLBB
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2012
• Last updated: May 23, 2012
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: May 2012
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthorityUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :

• The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses

• How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks

• How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal

• How LY2409021 works when given with metformin

• How daily dosing of LY2409021 affects the cells that produce insulin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin

• Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement

• Have a screening body mass index (BMI) of 20 to 40 kg/m^2 inclusive

• Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

Exclusion Criteria:

• Have used insulin for diabetic control within 1 year of study entry

• Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.

• Have clinically significant coronary artery disease

• Have clinically significant peripheral vascular disease

• Have clinical evidence of active diabetic proliferative retinopathy

• Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis

• Impaired renal function (serum creatinine greater than 115 micromoles/liter [µmol/L] [1.3 mg/dL] in women, greater than 130 µmol/L [1.5 mg/dL] in men)

• Have triglycerides greater than 4.5 millimoles per liter (mmol/L) [approximately 400 mg/dL] at screening

• Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months

• Are allergic to LY2409021 or similar drugs

• Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data

• Have used systemic glucocorticoids within 1 month prior to first dosing

• Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month

• Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Administered orally (capsule)
• LY2409021
Administered orally (capsule)

Locations

Country	Name	City	State
Singapore	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.	Singapore
United Kingdom	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.	Plymouth

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with one or more drug related adverse events (AEs) or any serious AEs		From first dose of study drug up to discharge (at least 28 days after last dose)	Yes
Secondary	Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021		From first study drug dose to Day 28 post last dose	No
Secondary	Pharmacokinetics: Maximum concentration (Cmax) of LY2409021		From first study drug dose to Day 28 post last dose	No
Secondary	Change in fasting blood glucose level		From Day -1 to Day 28 of dosing	No
Secondary	Change in incremental area under the curve (AUC) for glucose		From Day -1 to Day 28 of dosing	No
Secondary	Change in homeostasis model assessment of beta cell function (HOMA-B)		From baseline to Day 28	No
Secondary	Change in fasting glucagon level		From Day -1 to Day 28 of dosing	No
Secondary	Change in fasting insulin level		From Day -1 to Day 28 of dosing	No
Secondary	Change in fasting C-peptide level		From Day -1 to Day 28 of dosing	No
Secondary	Change in fasting glucagon-like peptide-1 (GLP-1) level		From Day -1 to Day 28 of dosing	No