Drug to Drug Interaction Study With ASP1941 and Metformin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-25

Study Completion Date

2009-12-09

Brief Summary

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

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ASP1941 + metformin

Oral

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

Tablet

Metformin

Intervention Type DRUG

Tablet

Placebo + metformin

Oral

Group Type PLACEBO_COMPARATOR

Metformin

Intervention Type DRUG

Tablet

Placebo

Intervention Type DRUG

Tablet

Interventions

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ASP1941

Tablet

Intervention Type DRUG

Metformin

Tablet

Intervention Type DRUG

Placebo

Tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No