A Phase II, 12-week, double-blind, randomised, parallel group, multi-centre, international trial to assess the effect on glycaemic control of five doses of HM11260C versus placebo or open-label liraglutide in subjects with type 2 diabetes

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)Body mass index (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 a 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

1)Pregnant or nursing (lactating) women
2)Diagnosis of type 1 diabetes mellitus
3)Uncontrolled diabetes defined as a fasting plasma glucose 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)The following medication exclusions apply:
a)Use of any concomitant medications at a dose that was not stable for the 3 months prior to randomisation, except as permitted below;
b)Use of a weight control treatment 3 months before screening, including any medication with a labelled reference to weight loss or weight gain and over-the-counter medications or herbal supplements;
c)Any antihyperglycaemic agents (including other incretin therapy such as dipeptidyl peptidase 4 inhibitors) other than metformin for > 2 weeks within the 3 months before screening or any use within 30 days of screening.;
d)Prior insulin use for a >= 3-month period at any time, use for > 2 weeks within 3 months before screening or any use within 30 days of screening;
e)Any previous treatment with a GLP-1 analogue ever including treatment in a clinical trial;
f)Any drugs that directly reduce gastrointestinal (GI) motility, including but not limited to chronic use of anticholinergics, antispasmodics, 5-hydroxytryptamine (5HT3) antagonists, dopamine antagonists or opiates within 4 weeks of screening;
g)Any daily medication with a history of causing upper GI AEs, such as bisphosphonates and high-dose acetylsalicylic acid (daily acetylsalicylic acid of 325 mg or less is allowed). Sites considering enrolling a patient on nonsteroidal anti-inflammatory drugs (NSAIDs) known to have a high incidence of GI side effects should contact the Medical Monitor before enrolling the patient;
h)Chronic anticoagulant therapy for any reason within 3 months before screening;
i)Current use of medications that prolong the QT interval/interval corrected by Fridericia formula (QTcF) (Section 13, Appendix 1)
j)Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives (of the used drug) of enrolment, whichever is longer
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 jeopardise a subject*s study compliance. Subjects who have been prescribed benzodiazepines, or low dose opiates for chronic conditions, may qualify for the study at the discretion of the investigator
25)Severe neuropathy, including but not limited to a) severe autonomic neuropathy (e.g., orthostatic hypotension or treated gastroparesis) or b) severe peripheral neuropathy (e.g., non healing diabetic ulcers or requires medication for neuropathic pain)
26)Is incapable of providing proper informed consent or complying with the study procedures
27)Atypical sleep patterns (e.g., those working late night or graveyard shifts)
28)A history of drug addiction, drug or alcohol abuse or heavy alcohol use in the previous 12 months. Heavy alcohol use is defined as more than 14 units per week for women or more than 21 units per week for men (a unit is 1.5 ounces [44 mL] of 80 proof distilled spirits, 4 ounces [118 mL] of wine, or 12 ounces [355 mL] of 3-5% beer)
29)Any other condition or clinically significant abnormal findings during the physical examination, assessment of medical history (including previous anaphylactic reactions or recent severe systemic illness), or clinical laboratory test results that, in the opinion of the investigator, would make the subject unsuitable for the study or would put them at additional risk during participation