Safety, Tolerability, Pharmacokinetics, and Efficacy of LY3053102 With 12 Weeks of Treatment in Patients With Type 2 Diabetes Mellitus
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Eli Lilly and Company
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: LY3053102 (Drug)
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
Intervention: Metformin (Drug)
Placebo
Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks
Intervention: Placebo (Drug)
Placebo
Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks
Intervention: Metformin (Drug)
Exenatide Extended-Release (ER)
Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks
Intervention: Exenatide ER (Drug)
Exenatide Extended-Release (ER)
Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks
Intervention: Metformin (Drug)
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
Intervention: LY3053102 (Drug)
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
Intervention: Exenatide ER (Drug)
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
Intervention: Metformin (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint
Time Frame: Baseline, Week 12
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
- Change From Baseline in Body Weight at 12-Week Endpoint(Baseline, Week 12)
- Percentage of Participants That Require Rescue Therapy(Baseline through Week 12)
- Percentage of Participants With Anti-Drug Antibodies to LY3053102(Baseline through Study Completion (Up to 6 Months))
- Percentage of Participants With Hypoglycemia(Baseline through Week 12)
- Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint(Baseline, Week 12)
- Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102(Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose)
- Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint(Week 12)
- Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint(Baseline, Week 12)
- Change From Baseline in Lipids at 12-Week Endpoint(Baseline, Week 12)
- Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])(Baseline, Week 12)
- Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])(Baseline, Week 12)