Type 2 Diabetes Mellitus MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Code: LY2409021
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
Other descriptive name: LY2409021
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women (not of child-bearing potential) aged at least 18 years with T2DM, treated with diet and exercise alone or in combination with stable doses of MET, HbA1c greater than or equal to 6.5% and less than or equal to 8.5% (assessed by the central laboratory at screening), BPs greater than 90/60 mm Hg and less than 140/90 mm Hg, if being treated for hypertension are taking 3 or fewer antihypertensive medications and have been taking the same medication regimens for at least 1 month before screening, and with stable body weights and body mass indexes great than or equal to 20 kg/m² and less than 40kg/m² will be enrolled. 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 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Have severe gastrointestinal (GI) disease that may significantly affect gastric emptying or motility Previous histories or active diagnoses of pancreatitis. Acute or chronic hepatitis, signs or symptoms of any other liver disease, or ALT level greater than 2.5 times the upper limit of normal (ULN) Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis. Mean resting PRs less than 60 bpm or greater than 100 bpm Current diagnosis or personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia, or Von Hippel-Lindau disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that the change from baseline in mean 24 hour systolic blood pressure of LY2409021 20 mg is noninferior to placebo at 6 weeks, as measured by ABPM, in subjects with T2DM.;Secondary Objective: To assess the difference between LY2409021 and placebo for additional measures of blood pressure and pulse rate and glycaemic control. To assess the effect of LY2409021 on safety measures To characterise the PK of LY2409021;Primary end point(s): Change from baseline in mean ABPM 24-hour SBP;Timepoint(s) of evaluation of this end point: Change from baseline over 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in mean ABPM 24-hour DBP. Mean daytime and nighttime SBP and DBP as measured by ABPM 24-hour, daytime, and nighttime peripheral PRs, pulse pressures, and MAPs, as measured by ABPM Glycemic control (HbA1c, FBG, and 4-point SMBG profiles) Safety measures: vital signs, TEAEs, body weight, laboratory analytes, and hypoglycemic events;Timepoint(s) of evaluation of this end point: 6 weeks | — |
Countries
Czech Republic, Mexico, Poland, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed