An study conducted in multiple countres to assess the control of glucose in patients with Diabetes Type 2. This study will compare 5 different dose levels of HM11260C (the study medication) with placebo (no active drug) and a liraglutide (a treatment for diabetes type 2 available by prescription). This will be a twelve week study where the study physician nor the patient will know whether the treatment is placebo or study medication. There is an equal chance of being assigned to any group.

Conditions: Type 2 Diabetes Mellitus
MedDRA version: 17.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2013-003625-29-ES

Lead Sponsor: Hanmi Pharmaceutical Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 255

Inclusion Criteria

1) Aged = 18 and < 75 years at screening
2) Diagnosed with T2DM for at least 3 months prior to screening
3) Received diet and exercise therapy with or without metformin monotherapy for at least
3 months prior to screening; for subjects who have taken metformin monotherapy, the
following minimum stable (i.e., at least 3 months on this dose) dose requirements apply:
a) = 1500 mg/day of metformin or
b) maximum tolerated dose (the investigator must have documented the reason why
up-titration to e.g., = 1500 mg/day was not possible) or
c) maximum dose according to the country-specific label
4) HbA1c levels of between = 7.0% and = 10.0%, at screening
5) BMI of < 40 kg/ m2 at screening
6) Females of child-bearing potential must test negative for serum pregnancy at screening
and agree to use a highly effective method of birth control throughout the study and for
at least 30 days after Visit 8/ET visit. Child-bearing potential is defined as women who
have not been surgically sterilized 6 weeks prior to screening or are post-menopausal
= 1 year.
A highly effective method of birth control is considered to be one of the following:
- An oral or implanted hormonal method of contraception (if it has been used
for = 3 months prior to study drug administration) while also using a barrier
method (i.e., a condom or diaphragm)
- A hormone or copper intrauterine device if it has been in place for = 3 months
prior to study drug administration (subjects using a nonhormonal or copper
intrauterine device should also use a barrier method [i.e., a condom or a
diaphragm])
- A vasectomised partner
- Total abstinence is acceptable; however, the subject must use a highly
effective method of contraception if the subject subsequently decides not to
abstain.
7) Male subjects must agree to practice highly effective birth control methods during the
conduct of the study and for at least 30 days after Visit 8/ET visit
8) Written informed consent must be obtained before any study-related assessment is performed
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 245
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1) Pregnant or nursing (lactating) women
2) Diagnosis of type 1 diabetes mellitus
3) Uncontrolled diabetes defined as a FPG level of > 240 mg/dL (13.3
mmol/L) at screening
4) A significant change in body weight (at least ± 10%) in the 3
months before screening
5) Medication exclusions apply
6) Known history of hypersensitivity to any of the study drugs or to
drugs of similar chemical classes
7) Any history of GI intolerance (prolonged nausea and vomiting,
chronic diarrhoea during the previous 6 months), gastric emptying
abnormality, inflammatory bowel disease, partial bypass (ileal bypass)
or gastric banding
8) Any previous GI bleeding or ulceration related to the use of NSAIDs
within 3 months before screening
9) Subjects with severe heart or circulatory disease within 6 months
prior to screening, defined as any one of the following:
a) Current symptomatic heart failure (New York Heart Association class
III or IV) (NYHA 1994; Section 14, Appendix 2);
b) A myocardial infarction, coronary artery bypass graft surgery, or
angioplasty within 6 months of screening;
c) Diagnosis of unstable angina requiring medication within 6 months
of screening; or
d) Any transient ischemic attack, cerebral infarct, or cerebral
haemorrhage within 6 months of screening
10) Poorly controlled hypertension (a resting systolic blood pressure
[BP] > 160 mm Hg and/or diastolic BP > 100 mm Hg at screening)
11) Long QT syndrome or prolongation of QTcF interval (QTcF interval >
450 ms for males and > 470 ms for females) at screening
12) A history of additional risk factors for torsade de pointes (TdP; e.g.,
heart failure, hypokalaemia, family history of Long QT Syndrome)
13) Liver disease, hepatitis, alanine transaminase (ALT) levels or
aspartate aminotransferase (AST) > 2.0 times the upper limit of normal,
or total bilirubin > 1.5 times upper limit of normal unless the subject has
a known history of Gilbert syndrome
14) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
using the Cockcroft Gault formula, at screening
15) Calcitonin levels > 20 pg/mL (> 20 ng/L) at screening
16) Personal or family history of medullary thyroid cancer (MTC) or a
genetic condition that predisposes to MTC (i.e., multiple endocrine
neoplasia type 2)
17) Plan to or have had radioactive iodine test with intravenous
administration of contrast material (such as intravenous pyelography,
intravenous cholangiography, angiography, or computed tomography
with contrast medium, etc) within 3 months of screening
18) Any planned elective hospitalisations
19) Known history of acute or chronic pancreatitis with presence of
raised serum amylase and lipase (= 3 times the upper limit of normal) at
screening
20) Fasting serum TG > 400 mg/dL (> 4.52 mmol/L) at screening (Visit
1B)
21) Proliferative retinopathy or maculopathy treated within the 6
months before screening or requiring acute treatment
22) History of or positive result at screening for hepatitis B surface
antigen (HBsAg), hepatitis C virus (HCV) antibody, or human
immunodeficiency virus (HIV) type 1 or 2 antibody
23) History of cancer, other than squamous cell or basal cell carcinoma
of the skin, that has not been in full remission for at least 5 years before
screening. (Any history of treated cervical intraepithelial neoplasia I or
cervical intraepithelial neoplasia II is allowed)
24) Use of or a positive screen for drugs of abuse (opiates, cocaine,
amphetamines, cannabinoids), barbiturates, or benzodiazepines that
may potentially j