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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014