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

Phase 1

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Exenatide ER; Drug: LY3053102; Drug: Placebo; Drug: Metformin

• Registration Number: NCT02020616
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Disposition First Submitted: 2015-05-08
• Disposition First Submitted QC: 2015-05-08
• Disposition First Posted: 2015-05-25
• Results First Submitted: 2017-09-27
• Results First Submitted QC: 2017-11-20
• Results First Posted: 2017-12-20
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide Extended-Release (ER)	Exenatide ER	Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks
LY3053102	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	Placebo	Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks
LY3053102 + Exenatide ER	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
LY3053102 + Exenatide ER	LY3053102	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
Placebo	Metformin	Stage 1 and Stage 2: Placebo to match LY3053102 administered by SC injection once a week for 12 weeks
LY3053102	Metformin	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
Exenatide Extended-Release (ER)	Metformin	Stage 1 and Stage 2: Exenatide ER 2 mg given by SC injection once a week for 12 weeks
LY3053102 + Exenatide ER	Metformin	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 Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint	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 Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight at 12-Week Endpoint	Baseline, Week 12	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).
Percentage of Participants That Require Rescue Therapy	Baseline through Week 12	Percentage of participants that required \>=1 rescue (blood glucose lowering) medications.
Percentage of Participants With Anti-Drug Antibodies to LY3053102	Baseline through Study Completion (Up to 6 Months)	Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value.
Percentage of Participants With Hypoglycemia	Baseline through Week 12	Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia.
Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint	Baseline, Week 12	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).
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	AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours.
Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint	Week 12	HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint	Baseline, Week 12	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).
Change From Baseline in Lipids at 12-Week Endpoint	Baseline, Week 12	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).
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])	Baseline, Week 12	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).
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])	Baseline, Week 12	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).

Trial Locations

Locations (5)

Orange County Research Center; 🇺🇸 Orange, California, United States

Compass Research; 🇺🇸 Orlando, Florida, United States

Clinilabs, Inc (New York); 🇺🇸 New York, New York, United States

Miami Research Associates; 🇺🇸 Miami, Florida, United States

Dallas Diabetes Endocrine Center; 🇺🇸 Dallas, Texas, United States