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

This study has been terminated.
(Lack of Efficacy)
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: December 13, 2013
Last updated: May 8, 2015
Last verified: May 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • Number of Participants Achieving Hemoglobin A1c (HbA1c) <7.0% or HbA1c ≤6.5% at 12 Week Endpoint [ Time Frame: Week 12 ]
  • Number of Participants that Require Rescue Therapy [ Time Frame: Baseline through Week 12 ]
  • Change from Baseline in Body Weight at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in 7-Point Blood Glucose Profile at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ]
  • Change from Baseline in Lipids at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ]
  • Number of Participants with Anti-Drug Antibodies to LY3053102 [ Time Frame: Baseline through Study Completion (up to 6 months) ]
  • Number of Participants with Hypoglycemia [ Time Frame: Baseline through Week 12 ]
  • Change from Baseline in Bone Metabolism at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ]
  • 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 ]
  • Change from Baseline in Bone Mineral Density Markers at 12 Week Endpoint [ Time Frame: Baseline, Week 12 ]

Enrollment: 60
Study Start Date: December 2013
Study Completion Date: February 2015
Primary Completion Date: February 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


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT02020616

  Show 50 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Eli Lilly and Company Identifier: NCT02020616     History of Changes
Other Study ID Numbers: 14515
I6I-MC-LMRB ( Other Identifier: Eli Lilly and Company )
Study First Received: December 13, 2013
Last Updated: May 8, 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017