type 2 diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: HM11260C
Product Code: HM11260C
Pharmaceutical Form: Injection*
Current Sponsor code: HM11260C
Other descriptive name: HM11260C
Concentration unit: µg/kg microgram(s)/kilogram
Concentrat
Sponsors
Hanmi Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gender : male/female 2. Age : 18 - 75 years, inclusive 3. BMI : 25 - 40 kg/m2 [Body Mass Index (BMI) (kg/m2) = Body weight (kg) ? Height2 (m2)] 4. Patients with type 2 diabetes mellitus for at least 3 months with fasting glucose 23.0 mIU/mL and serum oestradiol =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Positive for HBsAg, HIV or HCV 2. ALAT and ASAT liver enzymes above two times upper limit of normal 3. History of metabolic disease other than diabetes and dyslipidemia 4. Previous use of insulin for diabetes 5. History of alcohol abuse within 5 years prior to study entry or drug addiction (including soft drugs like cannabis products) 6. History of any cancer within 5 years prior to study entry (with the exception of non-melanoma skin cancer) 7. History of thyroid cancer at any point in time 8. Clinically significant cardiovascular disease 9. Lactating women 10. History of pancreatitis 11. History of other severe gastrointestinal diseases 12. History of relevant drug and/or food allergies 13. Previously treated with a GLP-1 analogue 14. Any other laboratory abnormality which in the opinion of the investigator could interfere with the efficacy or safety evaluations of HM11260C 15. Mental handicap 16. Use of concomitant medication, except for multivitamins and vitamin C, which are allowed up to 7 days prior to the first dose. Also use of stable co-medication with cholesterol and blood pressure lowering and alpha blockers is allowed during the study unless pharmacological interaction with the study compound is being expected. The use of a limited amount of acetaminophen is permitted. All other medication (including over the counter medication, health supplements, and herbal remedies such as St. John’s Wort extract) must have been stopped at least 14 days prior to the first dose. 17. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies (for men) / more than 2 other drug studies (for women) in the 10 months preceding the start of this study (this is the first administration of study drug). 18. Donation of more than 50 mL of blood within 60 days prior to drug administration. Donation of more than 1.5 litres of blood (for men) / more than 1.0 litres of blood (for women) in the 10 months preceding the start of this study. 19. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol 20. Intake of more than 24 units of alcohol per week (PRA standard: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits) 21. Illness within five days prior to drug administration 22. Intake within 48 h prior to the baseline 13C-breath test of corn, whatever its form (including corn flakes and corn-containing cereals or chips, popcorn, corn oil, polenta), cane sugar, exotic fruits (mangoes, pineapples, papaya, kiwis), fruits in syrup, dessert creams, ice creams, purslane and millet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety and tolerability profile of single escalating subcutaneous (sc) dose levels of HM11260C in adult patients with type 2 diabetes mellitus;Secondary Objective: to evaluate the dose response relationship of single escalating sc dose levels of HM11260C on pharmacodynamic (PD) parameters including 24-h glucose profiles (including fasting and post-prandial blood glucose), fasting fructosamine, C-peptide, fasting insulin, glucagon, lipids, gastric emptying, body weight, waist circumference, and a battery of safety laboratory parameters, incl. amylase, lipase, liver enzymes and hematologic parameters to evaluate the pharmacokinetic (PK) profiles of single dose levels of HM11260C to determine the pharmacologically active dose (PAD) of HM11260C (based on fasting glucose) as defined by the dose that results in a mean reduction in fasting glucose of more than 30 mg/dL (1.66 mmol/L) or 20% reduction from baseline, whichever is greater to assess the immunogenicity (anti-HM11260C antibodies and anti-HM11260C neutralizing antibodies) of a single sc dose of HM11260C ;Primary end point(s): Pharmacodynamics : glucose, insulin, C-peptide and glucagon concentrations, fructosamine and lipids (total cholesterol, HDL, LDL, VLDL, free fatty acids, triglycerides) concentrations, 13C-breath tests as a measure of gastric emptying, and Hunger, Craving and Fullness Questionnaire (VAS) Pharmacokinetics : serum HM11260C concentrations, PK parameters | — |
Countries
Netherlands
Outcome results
None listed