Type 2 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus
Conditions
Interventions
Product Name: Glucagon Receptor Antagonist I
Product Code: LY 2409021
Pharmaceutical Form: Capsule, hard
Current Sponsor code: LY 2409021
Other descriptive name: Glucagon Receptor Antagonist I
Concent
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients not of child-bearing potential with type 2 diabetes mellitus (T2DM) between 18 and 70 years old, inclusive, treated with diet and exercise alone or in combination with metformin (at least 1000 mg/day stable and unchanged for at least 3 months prior to screening) are eligible for this study. HbA1c value between 7.0% and 10.5%, inclusive and body mass index (BMI) between 25 to 45 kg/m2, inclusive. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) >2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening Current or previous diagnosis of Gilbert’s disease Nonfasting triglycerides >600 mg/dL Use of insulin or GLP-1 agonist for more than 5 days within the 3-month period prior to screening, or any oral antihyperglycemic medication other than metformin within the 3-month period prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the efficacy of LY2409021 administered once-daily as monotherapy or in combination with metformin by comparing against placebo the mean change in HbA1c from baseline to the end of the 24-week active treatment period.;Secondary Objective: To evaluate the safety and tolerability of oral doses of LY2409021 given once-daily for 24 weeks To evaluate and compare the effects of LY2409021 and placebo on blood glucose, insulin, glucagon, and glucagon-like peptide 1 (GLP-1) and safety parameters. To characterize the population pharmacokinetic and pharmacodynamic properties of LY2409021 and exploration of covariate correlations. To evaluate and compare the effect of LY2409021 and placebo on pancreatic islet beta-cell function To investigate and compare the effects of LY2409021 and placebo on markers of insulin sensitivity To evaluate and compare the effects of LY2409021 and placebo on blood lipids To evaluate if clinical and serum biomarkers are predictive of the efficacy and safety of LY2409021.;Primary end point(s): Change from baseline of HbA1c. | — |
Countries
Germany, Italy, Slovakia, Spain
Outcome results
None listed