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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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