Skip to content

Trial · Interventional

TerminatedPhase 1/2Results postedRegistry data

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

NCTNCT02020616 (opens ClinicalTrials.gov in a new tab)Other id14515Other idI6I-MC-LMRB

Overview

Status
Terminated
Phase
Phase 1/2
Enrollment
60 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Dec 2013
Primary completion
Feb 2015
Completion
Feb 2015
First posted
25 Dec 2013 (estimated)
Last update posted
8 Oct 2019
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2013201420152016
  1. Ph 1/2

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

    NCT02020616

    Dec 2013 to Feb 2015

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY3053102Drug
  • Exenatide ERDrug
  • PlaceboDrug
  • MetforminDrug

Arms4

  • 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

  • Placebo comparator

    Placebo

    Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks

  • Active comparator

    Exenatide Extended-Release (ER)

    Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks

  • Experimental

    LY3053102 + Exenatide ER

    Stage 2: LY3053102 administered by SC injection once a week for 12 weeks and exenatide ER 2 mg administered by SC injection once a week for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint

    Time frame · Baseline, Week 12

    Registry description

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect.

Secondary outcomes(11)
  1. Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint

    Time frame · Week 12

    Registry description

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

  2. Percentage of Participants That Require Rescue Therapy

    Time frame · Baseline through Week 12

    Registry description

    Percentage of participants that required \>=1 rescue (blood glucose lowering) medications.

  3. Change From Baseline in Body Weight at 12-Week Endpoint

    Time frame · Baseline, Week 12

    Registry description

    LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).

  4. Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint

    Time frame · Baseline, Week 12

    Registry description

    7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).

  5. Change From Baseline in Lipids at 12-Week Endpoint

    Time frame · Baseline, Week 12

    Registry description

    Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).

  6. Percentage of Participants With Anti-Drug Antibodies to LY3053102

    Time frame · Baseline through Study Completion (Up to 6 Months)

    Registry description

    Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value.

  7. Percentage of Participants With Hypoglycemia

    Time frame · Baseline through Week 12

    Registry description

    Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia.

  8. Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])

    Time frame · Baseline, Week 12

    Registry description

    LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).

  9. Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])

    Time frame · Baseline, Week 12

    Registry description

    LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).

  10. Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint

    Time frame · Baseline, Week 12

    Registry description

    LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).

  11. Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102

    Time frame · Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose

    Registry description

    AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint

GroupValue (Percent of HbA1c)Spread
Placebo-0.490.33
7 mg LY3053102-0.700.40
15 mg LY3053102-0.750.44
50 mg LY3053102-0.220.43
100 mg LY3053102-0.480.40
200 mg LY3053102-0.520.47
2 mg Exenatide ER-1.430.36
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 12

Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint

GroupValue (Percentage of Participants)
Placebo0.0
7 mg LY305310214.3
15 mg LY305310240.0
50 mg LY305310220.0
100 mg LY30531020.0
200 mg LY30531020.0
2 mg Exenatide ER83.3
Secondary outcomeNumber· Baseline through Week 12

Percentage of Participants That Require Rescue Therapy

GroupValue (Percentage of Participants)
Placebo0.0
7 mg LY30531020.0
15 mg LY305310212.5
50 mg LY305310214.3
100 mg LY30531020.0
200 mg LY30531020.0
2 mg Exenatide ER0.0
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Body Weight at 12-Week Endpoint

GroupValue (kilogram (kg))Spread
Placebo0.71.1
7 mg LY30531021.51.3
15 mg LY30531020.01.4
50 mg LY30531020.41.4
100 mg LY3053102-1.71.3
200 mg LY3053102-2.01.4
2 mg Exenatide ER-0.11.1
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint

GroupValue (milligram/deciliter (mg/dL))Spread
Placebo-23.415.8
7 mg LY3053102-18.719.4
15 mg LY3053102-57.721.6
50 mg LY3053102-34.921.9
100 mg LY30531024.718.3
200 mg LY3053102-26.825.8
2 mg Exenatide ER-47.919.4
Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Lipids at 12-Week Endpoint

GroupValue (mg/dL)Spread
Placebo1.02.2
7 mg LY30531026.02.6
15 mg LY30531029.32.9
50 mg LY30531026.42.9
100 mg LY30531026.02.6
200 mg LY305310211.43.1
2 mg Exenatide ER-2.32.2
Secondary outcomeNumber· Baseline through Study Completion (Up to 6 Months)

Percentage of Participants With Anti-Drug Antibodies to LY3053102

GroupValue (Percentage of Participants)
Placebo0
7 mg LY30531021
15 mg LY30531021
50 mg LY30531020
100 mg LY30531022
200 mg LY30531022
2 mg Exenatide ER2
Secondary outcomeNumber· Baseline through Week 12

Percentage of Participants With Hypoglycemia

GroupValue (Percentage of Participants)
Placebo10.0
7 mg LY305310212.5
15 mg LY30531020.0
50 mg LY30531020.0
100 mg LY305310212.5
200 mg LY305310212.5
2 mg Exenatide ER20.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo administered by SC QW for 12 weeks–1 / 106 / 10
7 mg LY30531027 mg LY3053102 administered SC QW for 12 weeks–0 / 84 / 8
15 mg LY305310215 mg LY3053102 administered SC QW for 12 weeks–0 / 84 / 8
50 mg LY305310250 mg LY3053102 administered SC QW for 12 weeks–0 / 74 / 7
100 mg LY3053102100 mg LY3053102 administered SC QW for 12 weeks–1 / 87 / 8
200 mg LY3053102200 mg LY3053102 administered SC QW for 12 weeks–0 / 87 / 8
2 mg Exenatide ER2 mg exenatide ER administered SC QW for 12 weeks–0 / 108 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.