Type 2 Diabetes Mellitus MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Januvia
Product Name: Sitagliptin
Product Code: Januvia
Pharmaceutical Form: Tablet
INN or Proposed INN: Sitagliptin
Other descriptive name: SITAGLIPTIN
Concentration unit: mg milligram(s)
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female (using contraception) subjects diagnosed with T2DM between the ages of 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: Known type 1 diabetes. More than 1 episode of severe hypoglycemia within 6 months prior to Visit 1. Two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to Visit 1. Severe gastrointestinal disease that may significantly impact gastric emptying or motility or having undergone gastric bypass or gastric banding surgery. Previous history or active diagnosis of pancreatitis. Positive hepatitis B surface antigen or hepatitis C antibody. Clinical signs or symptoms of liver disease, or hepatic aminotransferases (AST or ALT) >2.0× ULN or elevated alkaline phosphatase (>ULN) unrelated to bone metabolic disease. Elevated total bilirubin level (>ULN), clinically suspicious signs/symptoms of cirrhosis or history of cirrhosis. Current diagnosis, personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia (MEN), or Von Hippel-Lindau. Contraindications for MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare LY2409021 20 mg to placebo (PBO) on the change in hepatic fat fraction (HFF) from baseline (BL) to 6 months as measured by MRI in subjects with T2DM who are taking metformin (MET) and sulfonylurea (SU).;Secondary Objective: To assess the change from baseline in HFF determined by liver MRI at 1, 3, 6, and 12 months and 16 weeks (subset 24 weeks) after treatment discontinuation for each arm. To assess the incremental change in HFF during treatment by measuring HFF between: - 1 and 3 months - 3 and 6 months - 6 and 12 months To compare LY2409021 20 mg to PBO and SITA at 6 months and 12 months for the following measures: - Change in HbA1c - Change from baseline in hepatic aminotransferase levels including frequency of elevation and changes in the mean across time. - Change in fasting glucagon levels - Hepatobiliary adverse events of special interest (AESI). - Pancreas AESIs - Cardiovascular AESIs - Hypoglycemia AESIs - Additional PK/PD and Pharmacogenetic objectives ;Primary end point(s): The primary endpoint is the change in HFF from BL to 6-month endpoint. Baseline is defined as the HFF value at Visit 2 (Week -2).;Timepoint(s) of evaluation of this end point: 6-months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoints: Glucose - change from Baseline (BL) values will be provided for HbA1c, fasting plasma glucose, and 7-point SMBG profiles Weight - change from BL BMI - change from BL PK/PD Analyses: population-PK analysis Safety Endpoints: - Hepatic fat - supportive analysis for the primary analysis - AEs - Vital signs - Clinical Laboratory - Liver Biochemicals - Glucagon - Lipids - Hypoglycemic Events and Interventions - Adjudicated Cardiovascular Events - Deaths and nonfatal cardiovascular AEs will be adjudicated by an independent clinical endpoint committee;Timepoint(s) of evaluation of this end point: 6- and 12- months: Efficacy endpoints, Safety endpoints, PK/PD analyses | — |
Countries
Greece, Taiwan, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed