A Study of LY2405319 in Participants With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2405319 With 28 Days of Subcutaneous Injections in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869959
• Other study ID #: 12708
• Secondary ID: I1K-MC-GLUG
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2013
• Last updated: May 31, 2013
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the safety and tolerability of a drug called LY2405319. It will be given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study will determine how long the drug stays in the body and how it affects blood sugar levels. After screening, the study will last about 2 months for each participant. Participants will continue their pre-study regimen of diet and exercise alone, or in combination with metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of type 2 diabetes.

• Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days).

• Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0% inclusive or are on metformin and an additional OAM with an HbA1c value of 6.5% to 9.5% inclusive.

• Participants on another oral antihyperglycemic medication (OAM) in addition to metformin therapy may be randomized if removed from treatment of the other OAM = 14 days prior to study drug administration and fasting blood glucose is =145 milligrams per deciliter (mg/dL) and =270 mg/dL.

• Are females not of child-bearing potential due to surgical sterilization or are postmenopausal.

• Have a body mass index (BMI) =25 and =40.

• Have clinical laboratory test results within normal reference range for the population.

Exclusion Criteria:

• Use insulin, thiazolidinediones (TZDs), dipeptidyl peptidase (DPP) IV inhibitors, or exenatide during the 3 months prior to screening.

• Have had more than 1 episode of severe hypoglycemia requiring assistance of another person to administer a resuscitative action within 6 months prior to entry into the study, or are currently diagnosed with having hypoglycemia unawareness.

• Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months.

• Have any abnormality of the electrocardiogram (ECG) that will, in the opinion of the investigator, impair the ability to measure the QT. A QTc (Bazett's correction) interval >450 milliseconds (msec) for men and >470 msec for women or a PR interval more than 220 msec are specifically excluded. Have conduction abnormalities that may confound the QTc analysis.

• Have a personal or family history of long QT syndrome, family history of sudden death, or personal history of unexplained syncope within the last year; or use prescription or over-the-counter medications known to prolong the QT or QTc interval.

• Have diastolic blood pressure (DBP) =95 mm Hg and/or systolic blood pressure (SBP) =160 mm Hg.

• Have an active or untreated malignancy or have been in remission from a clinically significant malignancy for <5 years.

• Have a history of a transplanted organ.

• Evidence of a significant active, uncontrolled endocrine or autoimmune abnormality, as judged by the investigator at screening.

• Have a history of human immunodeficiency virus (HIV).

• Have a known allergy to yeast or yeast proteins, history of anaphylaxis with bronchospasm, or atopic dermatitis with chronic urticaria.

• Have any other condition (including known drug or alcohol abuse or psychiatric disorder within the last 6 months) that may preclude the patient from following and completing the protocol.

• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (including pancreatitis), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; or constituting a risk when taking the study medication; or of interfering with the interpretation of data.

• Are women who are breastfeeding.

• Have had a significant change in weight, defined as a gain or loss of at least 4 kilograms (kg) (9 pounds) in the 90 days prior to randomization.

• Have taken in the 30 days prior to randomization, a medication, herbal product, or nutritional supplement that affects adipose mass or distribution or energy balance.

• Are receiving chronic (>2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to second screening appointment.

• Have current or recent (within the past 3 months) use of gemfibrozil or fenofibrate, niacin, ezetimibe or bile acid binding resins (for example, cholestyramines). Stable statin therapy of =3 months will be allowed.

• Are currently taking central nervous system stimulant.

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:
• LY2405319
Administered SQ.
• Placebo
Administered SQ.

Locations

Country	Name	City	State
United States	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.	Cincinnati	Ohio
United States	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.	Cypress	California
United States	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.	Deland	Florida
United States	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.	Miramar	Florida
United States	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.	Portland	Oregon
United States	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.	San Antonio	Texas
United States	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.	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration		Baseline through Day 56	Yes
Secondary	Change from Baseline to Day 28 in Fasting Glucose		Baseline, Day 28	No
Secondary	7 Point Self-monitored Blood Glucose (SMBG)		Baseline and Week 4	No
Secondary	Change from Baseline to Week 4 in Glucose Area Under the Curve (AUC)		Baseline, Week 4	No
Secondary	Change from Baseline to Week 4 in Insulin Area Under the Curve (AUC)		Baseline, Week 4	No
Secondary	Change from Baseline to Week 4 in C-peptide Area Under the Curve (AUC)		Baseline, Week 4	No
Secondary	Change from Baseline to Day 28 in Fasting Lipid Profile		Baseline, Day 28	No
Secondary	Change from Baseline to Day 28 in Body Weight		Baseline, Day 28	No
Secondary	Change from Baseline to Day 28 in Adiponectin		Baseline, Day 28	No
Secondary	Change from Baseline to Day 28 in C-Reactive Protein		Baseline, Day 28	No
Secondary	Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2405319		Predose on Day 1 through Week 4 of study drug administration	No
Secondary	Pharmacokinetics: Maximum Concentration (Cmax) of LY2405319		Predose on Day 1 through Week 4 of study drug administration	No
Secondary	The Number of Participants with Anti-LY2405319 Antibodies		Predose on Day 1 through Day 56	No
Secondary	Change from Baseline to Day 28 in Eating Inventory for Cognitive Restraint of Eating, Disinhibition, and Hunger		Baseline, Day 28	No
Secondary	Change from Baseline to Day 28 in the Food Preference Questionnaire (FPQ) Score		Baseline, Day 28	No
Secondary	Change from Baseline to Day 28 in The Patient Health Questionnaire (PHQ-9) Score		Baseline, Day 28	No