A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SEQUENTIAL DOSE ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACODYNAMICS AND PHARMACOKINETICS OF SINGLE SUBCUTANEOUS DOSES OF HM11260C IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS - HM11260C SAD study in patients with type 2 diabetes mellitus

• Conditions: type 2 diabetes mellitus; MedDRA version: 12.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2010-019665-28-NL
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <240 mg/dL (<13.3 mmol/L) and HbA1c (glycosylated haemoglobin) between 6.0 and 10% inclusive
5.Must be treated with:
a. Diet and exercise only, or
b. A stable dose of one oral anti-diabetes medication, such as Metformin, sulphonylurea (SU), or a combination of Metformin and SU for 2 months before screening
6.Must be willing to wash-out glucose lowering drugs for 14 days prior to dosing
7.Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, powerdrinks), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
8.Are nonsmokers or smoker of fewer than 5 cigarettes/cigars/pipes per day as determined by history
9.Medical history without major pathology
10.Resting supine blood pressure between 90/40 mmHg and 150/95 mmHg, a resting pulse rate of 40 bpm or higher, and showing no clinically relevant deviations as judged by the Medical Investigator
11.Computerised (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Medical Investigator
12.Male subjects who are, and whose partners are, willing to use adequate contraception (double barrier method with spermicide) from the time of first dose until 3 months after the follow-up visit
13.Females who have a negative pregnancy test at screening and on each admission, and are of NCBP. NCBP females are defined as follows: Female subjects must be surgically sterile or post-menopausal (defined as at least 1 year post cessation of menses, follicular stimulating hormone >23.0 mIU/mL and serum oestradiol <163.3 pmol/L)
14.All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Medical Investigator
15.Willingness to sign the written Informed Consent Form (ICF)

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified