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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 19, 2014
Last verified: September 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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 44 Study Locations
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: September 19, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014