Clinical trial NCT02119819: A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Official title: Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Weight loss
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-22
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the safety and effectiveness of the study drug known as LY2944876 to exenatide extended-release and placebo in participants with type 2 diabetes mellitus. All drugs will be given by an injection under the skin. Participants remain on stable doses of metformin, as prescribed by their personal investigator if they were on metformin at study entry. Participants' involvement in the study is expected to last about 30 weeks.

Detailed description: The study will include a 12 week blinded treatment period, where neither the participant nor the investigator will know to which treatment each individual is assigned. Thereafter follows a 12 week period where participants and the investigator will know which treatment they are assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment in this period, those who received placebo will be followed without treatment.

Eligibility criteria: Inclusion Criteria:

* Men or women with diabetes mellitus Type 2
* Have screening HbA1c ≥7.0% and ≤10.5% either on diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for 3 months prior to screening
* Have body mass index (BMI) ≥23 and ≤45 kilograms per meter squared at screening

Exclusion Criteria:

* Women of child bearing potential
* Participants who have used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months
* Participants who have used insulin for diabetic control for more than 6 consecutive days within the prior year
* Participants with impaired renal function (serum creatinine \>124 micromole per liter (µmol/L) \[1.4 milligrams per deciliter (mg/dL)\] in women, \>133 µmol/L \[1.5 mg/dL\] in men)

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 24
timeFrame: Baseline, Week 24
measure: Percent Change From Baseline in Body Weight
timeFrame: Baseline, Week 12; Baseline, Week 24
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, Week 12; Baseline, Week 24
measure: Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, Week (Wk) 12; Baseline, Week 24
measure: Change From Baseline in Lipids
timeFrame: Baseline, Week 24
measure: Change From Baseline in Fasting Fibroblast Growth Factor 21
timeFrame: Baseline, Week 12; Baseline, Week 24
measure: Percentage of Participants Requiring Rescue Therapy
timeFrame: Baseline through Therapy Completion (Week 24)
measure: Percentage of Participants Developing Anti-Drug Antibodies to LY2944876
timeFrame: Week 12 and Week 24
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876
timeFrame: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876
timeFrame: Baseline, Week 8, Week 12, Week 16, Week 20, Week 24
measure: Change From Baseline in Adiponectin Levels
timeFrame: Baseline, Week 12; Baseline, Week 24
measure: Change From Baseline in Beta-Hydroxy Butyrate Levels
timeFrame: Baseline, Week 12; Baseline, Week 24
measure: Change From Baseline in Glucagon Levels
timeFrame: Baseline, Week 12; Baseline, Week 24
measure: Change From Baseline in Insulin Levels
timeFrame: Baseline, Week 12; Baseline, Week 24
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research 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: Palm Springs
country: United States
facility: Desert Medical Group Inc
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Fort Lauderdale
country: United States
facility: M & O Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Oviedo
country: United States
facility: Compass Research
state: Florida
city: Winter Haven
country: United States
facility: Clinical Research of Central Florida
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: Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Saint Louis
country: United States
facility: St John's Mercy Medical Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Washington
country: United States
facility: Mercy Health Research
state: Missouri
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: High Point
country: United States
facility: High Point Clinical Trials Center
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research LLC
state: North Dakota
city: Corvallis
country: United States
facility: The Corvallis Clinic P.C.
state: Oregon
city: Altoona
country: United States
facility: Blair Medical Associates, Inc.
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
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: Sugar Land
country: United States
facility: Southwest Health Associates, P.A.
state: Texas
city: Bountiful
country: United States
facility: Wade Family Medicine
state: Utah
city: Ampelokipoi
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: 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: Chihuahua
country: Mexico
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: Guadalajara
country: Mexico
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: Tampico
country: Mexico
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: Bialystok
country: Poland
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: Gdansk
country: Poland
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: Gdynia
country: Poland
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: Lodz
country: Poland
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: Poznan
country: Poland
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: Szczecin
country: Poland
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: Warsaw
country: Poland
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: Manati
country: Puerto Rico
facility: Manati Medical Center
city: San Juan
country: Puerto Rico
facility: American Telemedicine Center
city: Cluj-Napoca
country: Romania
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: Iaşi
country: Romania
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: Ploiesti
country: Romania
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: Targu Mures
country: Romania
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: Timisoara
country: Romania
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: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.