The effect of the co-administration of multiple oral doses of the fructose-1,6-bisphosphatase (FBPase) inhibitor CS-917 and glibenclamide on pharmacokinetics, safety and tolerability in diabetic patients (NIDDM) - Not available

• Conditions: Diabetes mellitus type 2

• Registration Number: EUCTR2004-003195-11-DE
• Lead Sponsor: Sankyo Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>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).