A study in Type 2 Diabetes Mellitus patients receiving blinded study drug to test a new study medication.

• Register: EUCTR
• Last refreshed on: 25 April 2016
• Main ID: EUCTR2013-004275-12-GR
• Date of registration: 06/03/2014
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A study in Type 2 Diabetes Mellitus patients receiving blinded study drug to test a new study medication.
• Scientific title: A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of LY2409021 Compared to Sitagliptin in Subjects with Type 2 Diabetes Mellitus
• Date of first enrolment: 27/05/2014
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004275-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Greece, Taiwan, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

Inclusion criteria:
Male or female (using contraception) subjects diagnosed with T2DM between the ages of 18 and <80 years old.

Have been treated with a stable dose of MET for at least 3 months and have been treated with an optimally effective and stable dose of an SU for at least 6 months prior to screening

HbA1c value between 7.0% and 10.0%, inclusive.

BMI between 20 and 45 kg/m2, inclusive.

Subjects must be willing to undergo an MRI and laboratory sampling according to the study schedule.
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus
MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

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)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Product Code: LY2409021
Pharmaceutical Form: Tablet
INN or Proposed INN: Not yet available
Current Sponsor code: LY2409021
Other descriptive name: LY2409021
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

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 Outcome(s)

Timepoint(s) of evaluation of this end point: 6- and 12- months:
Efficacy endpoints, Safety endpoints, PK/PD analyses

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

Secondary ID(s)

I1R-MC-GLDJ

Source(s) of Monetary Support

Eli Lilly and Company