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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00454233
First received: March 29, 2007
Last updated: October 14, 2008
Last verified: October 2008
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus Type 2
Drug: YM543
Drug: Metformin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo and Active Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Potential Efficacy of a 12-Week Treatment With YM543 in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination) [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel) [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: February 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose 1
Drug: YM543
Oral
Experimental: 2
Dose 2
Drug: YM543
Oral
Experimental: 3
Dose 3
Drug: YM543
Oral
Experimental: 4
Dose 4
Drug: YM543
Oral
Active Comparator: 5 Drug: Metformin
Oral
Placebo Comparator: 6 Drug: Placebo
oral

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454233

Locations
Russian Federation
Ekaterinburg, Russian Federation
4 Sites
Moscow, Russian Federation
N. Novgorod, Russian Federation
Petrozavodsk, Russian Federation
Samara, Russian Federation
10 Sites
St. Petersburg, Russian Federation
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00454233     History of Changes
Other Study ID Numbers: 543-CL-003, EudraCT number: 2006-001110-33
Study First Received: March 29, 2007
Last Updated: October 14, 2008
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Astellas Pharma Inc:
Diabetes Mellitus Type 2
YM543
Treatment
Safety
efficacy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014