Study Stopped
The overall benefit-risk profile did not support continued development of LY2409021 for type 2 diabetes.
A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of LY2409021 Compared to Sitagliptin in Subjects With Type 2 Diabetes Mellitus
3 other identifiers
interventional
174
4 countries
33
Brief Summary
The intent of this study is to assess the safety of LY2409021 in participants with Type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. The study treatment is expected to last 12 months (52 weeks).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 diabetes-mellitus-type-2
Started Apr 2014
Typical duration for phase_2 diabetes-mellitus-type-2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 8, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
April 24, 2018
CompletedOctober 9, 2019
September 1, 2019
1.4 years
April 8, 2014
March 24, 2018
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to 6 Months in Hepatic Fat Fraction
The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit.
Baseline, 6 months
Secondary Outcomes (14)
Change From Baseline to 6 Months in Alanine Aminotransferase Levels
Baseline, 6 months
Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI)
Baseline, 6 months
Change From Baseline to 6 Months in Fasting Lipids Levels
Baseline, 6 months
Change From Baseline to 6 Months in Fasting Blood Glucagon
Baseline, 6 months
Change From Baseline to 6 Months in Body Weight
Baseline, 6 months
- +9 more secondary outcomes
Study Arms (3)
LY2409021
EXPERIMENTAL20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Sitagliptin
ACTIVE COMPARATOR100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Placebo
PLACEBO COMPARATORPlacebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Interventions
Eligibility Criteria
You may qualify if:
- Have been treated with a stable dose of metformin for at least 3 months and have been treated with an optimally effective and stable dose of an sulfonylurea for at least 6 months prior to screening.
- HbA1c value between 7.0% and 10.0%, inclusive.
- Body mass index (BMI) between 20 and 45 kilograms/square meter (kg/m\^2), inclusive.
You may not qualify if:
- Known type 1 diabetes mellitus.
- More than 1 episode of severe hypoglycemia within 6 months prior to screening.
- Two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
- Severe gastrointestinal disease that may significantly impact gastric emptying or motility or having undergone gastric bypass or gastric banding surgery.
- Previous history or active diagnosis of pancreatitis.
- Positive hepatitis B surface antigen or hepatitis C antibody.
- Clinical signs or symptoms of liver disease, or hepatic aminotransferases (aminotransferase or alanine aminotransferase) greater than 2.0Ă— upper limit of normal (ULN) or elevated alkaline phosphatase (greater than ULN) unrelated to bone metabolic disease.
- Elevated total bilirubin level (greater than ULN), clinically suspicious signs/symptoms of cirrhosis or history of cirrhosis.
- Current diagnosis, personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia (MEN), or Von Hippel-Lindau.
- Contraindications for magnetic resonance imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
John Muir Health Network - The Osteoporosis Center
Concord, California, 94520, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
National Research Institute
Los Angeles, California, 90057, United States
Suncoast Research Group, LLC
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33175, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Midwest CRC
Crystal Lake, Illinois, 60012, United States
Iderc, P.L.C.
Des Moines, Iowa, 50314, United States
Cotton O'Neil Clinic
Topeka, Kansas, 66606, United States
Centex Studies, Inc
Lake Charles, Louisiana, 70601, United States
Cosmopolitan International Diabetes Center
Columbia, Missouri, 65212, United States
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
SHS Clinical Research Group
Toms River, New Jersey, 08753, United States
Office:Alwine,Lk
Downingtown, Pennsylvania, 19335, United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, 37411, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Galenos Research
Dallas, Texas, 75251, United States
San Gabriel Clinical Research
Georgetown, Texas, 78626, United States
Oakwell Clinical Research
San Antonio, Texas, 78218, United States
Victorium Clinical Research
San Antonio, Texas, 78240, United States
Polyclinic
Seattle, Washington, 98104, 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.
Athens, 11527, Greece
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.
Thessaloniki, 54636, Greece
PRADNET, Inc. Centro Especializado de Nutricion y Bariatria
Hato Rey, 00917, Puerto Rico
American Telemedicine Center
San Juan, 00917-3104, Puerto Rico
GCM Medical Group PSC
San Juan, 909, Puerto Rico
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.
Changhua, 500, Taiwan
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.
Yong Kung City, 71004, Taiwan
Related Publications (1)
Kazda CM, Frias J, Foga I, Cui X, Guzman CB, Garhyan P, Heilmann C, Yang JA, Hardy TA. Treatment with the glucagon receptor antagonist LY2409021 increases ambulatory blood pressure in patients with type 2 diabetes. Diabetes Obes Metab. 2017 Aug;19(8):1071-1077. doi: 10.1111/dom.12904. Epub 2017 Mar 27.
PMID: 28191913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Terminated, The overall benefit-risk profile did not support continued development of LY2409021 for type 2 diabetes.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2014
First Posted
April 10, 2014
Study Start
April 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 9, 2019
Results First Posted
April 24, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.