A Safety and Efficacy Study With YM543 in Type 2 Diabetes Mellitus Subjects

Astellas

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Placebo; Drug: YM543; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454233

543-CL-003

EudraCT number: 2006-001110-33

Details and patient eligibility

About

The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients

Enrollment: 97 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naive subjects diagnosed with T2DM
• Stable diet and exercise program for at least 6 weeks
• Inadequate glycemic control indicated by HbA1c and FPG level at Visit 1

Exclusion criteria

• Any known complication of T2DM indicating a late disease state, clinical manifestations of macro- and/or micro vascular disorders
• Use of insulin or oral blood glucose lowering drugs in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

Dose 1

Treatment:

Drug: YM543

2

Experimental group

Description:

Dose 2

Treatment:

Drug: YM543

3

Experimental group

Description:

Dose 3

Treatment:

Drug: YM543

4

Experimental group

Description:

Dose 4

Treatment:

Drug: YM543

5

Active Comparator group

Treatment:

Drug: Metformin

6

Placebo Comparator group

Treatment:

Drug: Placebo