Diabetes mellitus type 2
Conditions
Interventions
Product Name: Not applicable
Product Code: CS-917
Pharmaceutical Form: Tablet
INN or Proposed INN: Not available
CAS Number: N.a.
Current Sponsor code: CS-917
Concentration unit: mg milligram(s)
Conce
Sponsors
Sankyo Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects with non-insulin dependent type 2 diabetes mellitus (NIDDM) documented by C-peptide secretion (C-peptide =0.2 pmol/mL) at screening 2. Diet-treated subjects or subjects in whom it is medically justifiable to withdraw oral anti-diabetic treatment during the study 3. Negative serum pregnancy test at screening and check-in of each period. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or should use one of the following acceptable birth control methods: (1) barrier methods, including condoms (males), and diaphragms (cervical caps) with intra-vaginal spermicide (including jellies, foams and suppositories), or (2) intra-uterine device (IUD) for the entire duration of their participation in the study and up to one month (i.e. one complete menstrual cycle) whichever is longer, after the last dose of study drug. Note: A female of non-childbearing potential will be defined as one who has been post-menopausal for at least one year or has been surgically sterilised or had a hysterectomy at least three months prior to screening. 4. 18–70 years of age (inclusive) 5. BMI 22–35 kg/m2 6. HbA1c of =6.5% at screening 7. Fasting plasma glucose (FPG): at screening: =16.7 mmol/L (=300 mg/dL) and on Day –1 prior to first dosing: 8.9–16.7 mmol/L (160–300 mg/dL), inclusive 8. Normotensive subjects or stable blood pressure on anti-hypertensive medication 9. Signed Informed Consent Form 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects with type 1 diabetes or need for insulin (IDDM) 2. Subjects with diabetic complications 3. Subjects who experienced hypoglycaemic episodes in the past 6 months 4. Need for concomitant medication; use of prescription drugs within 14 days or use of non-prescription drugs within seven days (including herbals) with the following exception: stable treatment with anti-hypertensive (beta-blockers are not allowed), antilipidaemic or antirheumatic agents, and medication for coronary heart disease 5. Intake of any investigational drug within three months prior to the first intake of study medication (Day 1 of Period 1). 6. Severe drug allergy or serum sickness 7. Serum creatinine >110 µmol/L for female and >135 µmol/L for male subjects at screening 8. Abnormalities of liver function parameters or any abnormal result in haematology or clinical chemistry results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of CS-917 on the plasma pharmacokinetics of glibenclamide and the effects of glibenclamide on the plasma pharmacokinetics of CS-917, the intermediate metabolite R-134450, the active metabolite R-125338 and the metabolite R-143047 at steady-state in NIDDM patients.;Secondary Objective: To assess the safety and tolerability of CS-917 alone, of glibenclamide alone and of CS-917 co-administered in NIDDM patients. To assess the effect of co-administration of CS-917 and glibenclamide on plasma glucose and lactic acid concentrations.;Primary end point(s): The following pharmacokinetic parameters will be calculated using a non-compartmental approach: AUC(SS,0-tau), AUC(SS,0-inf), C(SS,max), C(SS,min), tmax, t1/2, VSS/f, MRT(SS,0-inf), CLSS/f (for CS-917 and glibenclamide only). | — |
Countries
Germany
Outcome results
None listed