A Study of LY2405319 in Participants With Type 2 Diabetes

NCT01869959 | Completed Phase 1 Results

• 2 other identifiers: 12708I1K-MC-GLUG
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  The number of participants with 1 or more SAEs considered by the investigator to be related to study drug administration is reported. SAEs were classified using the Medical Dictionary for Regulatory Activities (MedDRA) 11.0. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Baseline through Day 56

Secondary Outcomes (15)

• Change From Baseline to Day 28 in Fasting Glucose

  Baseline, Day 28

• 7 Point Self-monitored Blood Glucose (SMBG)

  Baseline (Day -5, -4, or -3) and Week 4 (Days 24, 25, or 26)

• Change From Baseline to Week 4 in Glucose Area Under the Curve (AUC)

  Predose and 2 hours postdose (Baseline, Week 4)

• Change From Baseline to Week 4 in Insulin Area Under the Curve (AUC)

  Predose and 2 hours postdose (Baseline, Week 4)

• Change From Baseline to Week 4 in C-peptide Area Under the Curve (AUC)

  Predose and 2 hours postdose (Baseline, Week 4)

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.

Drug: Placebo

3 mg LY2405319

EXPERIMENTAL

Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days.

Drug: LY2405319

10 mg LY2405319

EXPERIMENTAL

Participants received 10 mg LY2405319 injected SC once daily for 28 days.

Drug: LY2405319

20 mg LY2405319

EXPERIMENTAL

Participants received 20 mg LY2405319 injected SC once daily for 28 days.

Drug: LY2405319

Interventions

LY2405319 DRUG

Administered SC

10 mg LY2405319; 20 mg LY2405319; 3 mg LY2405319

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a diagnosis of T2DM.
• Are on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days) regimen.
• Have a glycosylated hemoglobin A1c (HbA1c) value of 7.0% to 10.0%, inclusive, or are on metformin and an additional oral antidiabetic medication (OAM) with an HbA1c value of 6.5% to 9.5%, inclusive.
• Participants on another 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 mg 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.

You may not qualify if:

• 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 corrected QC \[QTc\] \[Bazett's correction\] interval \>450 milliseconds \[msec\] for men and \>470 msec for women or a PR interval \>220 msec are specifically excluded) or have conduction abnormalities that may confound the QTc analysis.
• Have a personal or family history of long QT syndrome, family history of sudden death, 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 millimeters of mercury (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 participant 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; of 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (7)

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, 90630, United States

Location

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, 92780, United States

Location

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, 32720, United States

Location

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, 33025, United States

Location

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, 45212, United States

Location

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, 97239, United States

Location

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, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LY2405319

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 20, 2017
• Results First Posted: March 20, 2017

Record last verified: 2017-01

Locations

US (7)