A Study of the Safety and Effectiveness of LY3053102 in Participants With Type 2 Diabetes

This study is currently recruiting participants.
Verified January 2014 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02020616
First received: December 13, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to investigate the safety and effectiveness of the study drug known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be given in different doses as an injection under the skin. The study is expected to last up to 6 months for each participant. Participants may remain on stable-dose metformin as prescribed by their personal physician.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: LY3053102
Drug: Exenatide extended release
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics, and Efficacy of LY3053102 With 12 Weeks of Treatment in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Hemoglobin A1c (HbA1c) at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants Achieving Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% at 12 Week Endpoint [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants that Require Rescue Therapy [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Weight at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-Point Blood Glucose Profile at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Lipids at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants with Anti-Drug Antibodies to LY3053102 [ Time Frame: Baseline through Study Completion (up to 6 months) ] [ Designated as safety issue: No ]
  • Number of Participants with Hypoglycemia [ Time Frame: Baseline through Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in Bone Metabolism at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-Time Curve at Steady State (AUCt,ss) of LY3053102 [ Time Frame: Predose to Steady State after 12 Weeks of Study Drug ] [ Designated as safety issue: No ]
  • Change from Baseline in Bone Mineral Density Markers at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: December 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY3053102
Stage 1: Escalating dose (7 milligrams [mg] up to 200 mg) of LY3053102 administered once a week by subcutaneous (SC) injection for 12 weeks. Stage 2: LY3053102 administered once a week by SC injection for 12 weeks
Drug: LY3053102
Administered SC
Drug: Placebo
Administered SC
Placebo Comparator: Placebo
Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks
Drug: Placebo
Administered SC
Active Comparator: Exenatide
Stage 1 and Stage 2: Exenatide extended release 2 mg given by SC injection once a week for 12 weeks
Drug: Exenatide extended release
Administered SC
Drug: Placebo
Administered SC
Experimental: LY3053102 + Exenatide
Stage 2: LY3053102 administered by SC injection once a week for 12 weeks and exenatide extended release 2 mg administered by SC injection once a week for 12 weeks
Drug: LY3053102
Administered SC

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Participants with type 2 diabetes mellitus for at least 6 months before entering the trial based on the disease diagnostic criteria (World Health Organization [WHO]) classification managed with diet or exercise alone or with a stable dose of metformin of at least 1000 mg/day for at least 60 days before screening or on metformin and an eligible second oral anti-hyperglycemic medication after a 60-day washout of the second oral anti-hyperglycemic medication
  • Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
  • Have a hemoglobin A1c value of ≥7.0% and ≤10.5%, if on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days), or have a hemoglobin A1c value of ≥7.0% and ≤9.5%, and are on an appropriate diet and exercise regimen, a stable dose of metformin and willing to discontinue a second oral anti-hyperglycemic medication
  • Have a body mass index ≥23 and ≤45 kilograms per square meter (kg/m^2)

Exclusion Criteria

  • Have used insulin for diabetic control for more than 6 consecutive days within 1 year prior to screening
  • Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 2 months, prior to the first week of the study
  • Have hepatitis B and/or positive hepatitis B surface antigen. hepatitis C or human immunodeficiency virus (HIV) and/or positive HIV antibodies
  • Have known or suspected cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing
  • Have cardiac disease with functional status that is New York Heart Association Class II, III, or IV or in the last 6 months have had any of the following: a history of myocardial infarction , unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, or cerebrovascular accident (for example, stroke)
  • Have poorly controlled hypertension, malignant hypertension, renal artery stenosis, and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days prior to the first week of the study
  • Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase or aspartate aminotransferase levels >2 times the upper limit of the reference range
  • Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone which, in the opinion of the investigator, would pose a risk to participant safety. Participants on a stable dose of thyroid replacement therapy may be eligible if they meet the other criteria
  • Have clinically significant peripheral vascular disease, or clinical evidence of active diabetic proliferative retinopathy, (known significant autonomic neuropathy) as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
  • Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
  • Have impaired renal function
  • Have fasting triglycerides >500 milligrams per deciliter (mg/dL) at screening
  • Have experienced a keto-acidotic episode requiring hospitalization in the last 6 months
  • Have an electrocardiogram (ECG) considered to be indicative of cardiac disease
  • Have personal or family history of long QT syndrome, family history of sudden death in a first-degree relative before age 40, or personal history of unexplained syncope within the last year. Use of prescription or over-the-counter medications known to prolong the QT or QTc interval
  • Have a history of bone disease (including osteoporosis or unhealed fractures), evidence of osteoporosis (femoral neck or lumbar spine T-score <-2.5) determined by dual X-ray absorptometry (DXA) scan at screening, evidence of osteopenia (T-score between -1.0 and -2.5 at the femoral neck or lumbar spine) with a high risk of fracture based on risk factors or current active treatment of periodontal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02020616

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

Locations
United States, California
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. Recruiting
Orange, California, United States, 92868
Contact: Eli Lilly         
United States, Florida
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. Recruiting
Miami, Florida, United States, 33156
Contact: Eli Lilly         
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. Recruiting
Orlando, Florida, United States, 32806
Contact: Eli Lilly         
United States, New York
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. Recruiting
New York, New York, United States, 10013
Contact: Eli Lilly         
United States, Texas
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. Recruiting
Dallas, Texas, United States, 75230
Contact: Eli Lilly         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM -5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02020616     History of Changes
Other Study ID Numbers: 14515, I6I-MC-LMRB
Study First Received: December 13, 2013
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014