Type 2 Diabetes Mellitus MedDRA version: 17.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Hanmi Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 ingredient of the study drug 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) (Section 15, App 3); 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 mmHg and/or diastolic BP > 100 mmHg 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 aminotransferase (ALT) levels or aspartate aminotransferase (AST) > 2.0 times the upper limit of normal (ULN), or total bilirubin > 1.5 times the ULN unless the subject has a known history of Gilbert’s syndrome 14. Estimated glomerular filtration rate (eGFR) 20 pg/mL (> 20 ng/L) at screening 16. Personal or family (siblings/parents) 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 a radioactive iodine test with intravenous administration of contrast material (such as intravenous pyelography, intravenous cholangiography, angiography, or computed tomography with contrast medium) 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 ULN) 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 cannabis (recreational or therapeutic) or a positive screen for drugs of abuse (opiates, cocaine, amphetamines, cannabinoids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess and compare the efficacy of three doses of HM11260C (once monthly dosing) versus placebo on glycaemic control as assessed by the change in HbA1c over the 16 weeks from baseline in subjects with T2DM receiving a stable dose of metformin;Secondary Objective: • To assess and compare the safety and tolerability of HM11260C vs placebo • To assess and compare HM11260C antibody formation • To assess and compare the effect on overall diabetes-related parameters (fasting plasma glucose [FPG], 7-point blood glucose profile, fasting insulin, C peptide and glycated albumin) of HM11260C versus placebo over the 16 weeks from baseline • To assess and compare the effect on body weight of HM11260C vs placebo over the 16 weeks from baseline • To assess and compare the effect on the lipid profile (low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C] and triglyceride [TG]) of HM11260C versus placebo over the 16 weeks from baseline • To determine the PK of HM11260C to explore the exposure-response relationship between HM11260C concentrations and pharmacodynamic (PD) measurements by a PK/PD modelling analysis. Graphical exploration of the exposure-response relationship will be performed, as appropriate;Primary end point(s): The primary variable is HbA1c levels, from samples collected at screening, before dosing on Days 1, 15, 29, 57, and 85 of the treatment period, and at the follow-up visits on Days 113 and 155. HbA1c levels will be used to demonstrate the efficacy of three doses of HM11260C versus placebo on glycaemic control. ;Timepoint(s) of evaluation of this end point: The primary variable is HbA1c levels, from samples collected at screening, before dosing on Days 1, 15, 29, 57, and 85 of the treatment period, and at the follow-up visits on Days 113 and 155. HbA1c levels will be used to demonstrate the efficacy of three doses of HM11260C versus placebo on glycaemic control. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • HbA1c • FPG • 7-point blood glucose profile (diary) • Other diabetes-related parameters (insulin, C-peptide, glucagon and glycated albumin) • Serum lipid profile (LDL-C, HDL-C and TG) • Body weight ;Timepoint(s) of evaluation of this end point: Change from baseline | — |
Countries
Germany, Hungary, Italy, Korea, Republic of, Spain, United States
Contacts
Public ContactClinical director’s office
Hanmi Pharmaceutical Co., Ltd.
Outcome results
None listed