4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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Primary objective: safety and tolerability of BI 10773 in male and female patients with type 2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo to BI 10773

Intervention Type DRUG

BI 10773 low dose

Group Type EXPERIMENTAL

BI 10773 low dose

Intervention Type DRUG

BI 10773 medium dose

Group Type EXPERIMENTAL

BI 10773 medium dose

Intervention Type DRUG

BI 10773 high dose

Group Type EXPERIMENTAL

BI 10773 high dose

Intervention Type DRUG

Interventions

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BI 10773 low dose

Intervention Type DRUG

placebo to BI 10773

Intervention Type DRUG

BI 10773 medium dose

Intervention Type DRUG

BI 10773 high dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and postmenopausal or hysterectomised female patients with type 2 diabetes
* Age \>18 and \< 70 years
* BMI \>18.5 and \<40 kg/m2

Exclusion Criteria

* Antidiabetic treatment with insulin or glitazones or with more than one oral hypoglycaemic agent;
* Fasted blood glucose \> 240 mg/dl (\>13.3 mmol/L) or a blood glucose level above 400 mg/dl (22.2 mmol/L) postprandially;
* HbA1c \> 8.5 %

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No