Clinical trial NCT02111096: A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 2.0× 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.

Primary outcomes:
measure: Change From Baseline to 6 Months in Hepatic Fat Fraction
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change From Baseline to 6 Months in Alanine Aminotransferase Levels
timeFrame: Baseline, 6 months
measure: Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI)
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Fasting Lipids Levels
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Fasting Blood Glucagon
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Body Weight
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Fasting Plasma Glucose
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Blood Pressure
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in Pulse Rate
timeFrame: Baseline, 6 months
measure: Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)
timeFrame: Baseline, 6 months
measure: Population Pharmacokinetics: Apparent Clearance of LY2409021
timeFrame: Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,
measure: Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021
timeFrame: Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,
measure: Rate of Hypoglycemic Events Adjusted Per 30 Days
timeFrame: Baseline through 6 months
measure: Number of Participants With Hypoglycemic Events
timeFrame: Baseline through 6 months
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Health Network - The Osteoporosis Center
state: California
city: Fresno
country: United States
facility: Valley Endocrine, Fresno
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Honolulu
country: United States
facility: University of Hawaii
state: Hawaii
city: Honolulu
country: United States
facility: East West Medical Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Chicago
country: United States
facility: Cedar-Crosse Research Center
state: Illinois
city: Crystal Lake
country: United States
facility: Midwest CRC
state: Illinois
city: Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Clinic
state: Kansas
city: Lake Charles
country: United States
facility: Centex Studies, Inc
state: Louisiana
city: Columbia
country: United States
facility: Cosmopolitan International Diabetes Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Toms River
country: United States
facility: SHS Clinical Research Group
state: New Jersey
city: Downingtown
country: United States
facility: Office:Alwine,Lk
state: Pennsylvania
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Galenos Research
state: Texas
city: Georgetown
country: United States
facility: San Gabriel Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Oakwell Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Victorium Clinical Research
state: Texas
city: Seattle
country: United States
facility: Polyclinic
state: Washington
city: Athens
country: Greece
facility: 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.
city: Thessaloniki
country: Greece
facility: 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.
city: Hato Rey
country: Puerto Rico
facility: PRADNET, Inc. Centro Especializado de Nutricion y Bariatria
city: San Juan
country: Puerto Rico
facility: American Telemedicine Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: Changhua
country: Taiwan
facility: 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.
city: Yong Kung City
country: Taiwan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.