Drug to Drug Interaction Study With ASP1941 and Metformin

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01302145

Collaborator

(none)

Enrollment

Locations

Arms

9.4

Actual Duration (Months)

7.2

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study to investigate the effect on safety, pharmacokinetics and pharmacodynamics when ASP1941 is administered as add-on therapy to metformin.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: ASP1941 Drug: Metformin Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Double-blind, Randomized, Placebo-controlled, Parallel Design Study, in Patients With Type 2 Diabetes Mellitus, to Investigate the Safety, Pharmacokinetics and Pharmacodynamics Interactions of Multiple Oral Doses of ASP1941 and Metformin

Actual Study Start Date :

Feb 25, 2009

Actual Primary Completion Date :

Dec 9, 2009

Actual Study Completion Date :

Dec 9, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP1941 + metformin Oral	Drug: ASP1941 Tablet Drug: Metformin Tablet
Placebo Comparator: Placebo + metformin Oral	Drug: Metformin Tablet Drug: Placebo Tablet

Arm

Intervention/Treatment

Experimental: ASP1941 + metformin

Oral

Drug: ASP1941

Tablet

Drug: Metformin

Tablet

Placebo Comparator: Placebo + metformin

Oral

Drug: Metformin

Tablet

Drug: Placebo

Tablet

Outcome Measures

Primary Outcome Measures

Safety assessed by incidence of adverse events, vital signs, 12-lead ECG and glucose monitoring [5 weeks]

Secondary Outcome Measures

Pharmacodynamics assessed by serum glucose change [5 weeks]
Pharmacokinetics assessed by metformin plasma concentration change [5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects with type 2 diabetes
Stable disease under metformin monotherapy (between 1500-3000

mg/day) or dual therapy with metformin (1500-3000 mg/day) and a Sulfonylureum Derivative (SUD) for at least 3 months

Fasting Serum Glucose: 7-11.5 mmol/l (after wash-out)
Stable Fasting Blood Glucose (FBG) at the end of wash-out
BMI between 18.5 and 40.0 kg/m2, inclusive

Exclusion Criteria:

Subjects with type 1 diabetes
Any diabetes related macro-complications, painful diabetic neuropathy, diabetic macular edema or diabetic proliferative retinopathy
Clinical significant renal disease (CLcr <60 ml/min as assessed during a 24h creatinine clearance on Day-2
Recent evidence (e.g. within the last 6 months) of severe hypoglycemia, for example plasma glucose <3 mmol/l (<55 mg/dl) or requiring hospitalization
Pulse <40 or >90; Systolic Blood Pressure >160 mmHg; Diastolic Blood Pressure > 100 mmHg