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GLP-1 Agonist AVE0010 in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation in Monotherapy (GETGOAL-MONO Japan LTS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00905255
First received: May 14, 2009
Last updated: February 21, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and tolerability of AVE0010 once daily treatment in monotherapy in type 2 diabetes patients in Japan over 76 weeks of treatment.

The primary objective of this study is to evaluate the safety and tolerability of AVE0010 once daily treatment in monotherapy in type 2 diabetes patients in Japan over 24 weeks of treatment.

The secondary objectives are to assess the overall safety of AVE0010 once daily treatment in monotherapy at weeks 52 and 76 in patients with type 2 diabetes in Japan, and to assess the effects of AVE0010 on HbA1c reduction, body weight and fasting plasma glucose over a period of 52 weeks.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Lixisenatide (AVE0010)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Parallel-group (One-step Titration and Two-step Titration), Multicenter 52-week Study Followed by a 24-week Extension Assessing the Safety and Tolerability of AVE0010 Monotherapy in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Safety in terms of adverse and serious adverse events, vital signs, ECG, safety laboratory for each one-step and two-step titration group [ Time Frame: at week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall safety on the pooled data of the one-step and two-step titration arms [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Overall safety on the pooled data of the one-step and two-step titration arms [ Time Frame: Week 76 ] [ Designated as safety issue: Yes ]
  • Change in HbA1c from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

two step titration

76 weeks of open-label treatment

 Drug: Lixisenatide (AVE0010)
Subcutaneous injection
Experimental: 2

one step titration

76 weeks of open-label treatment

 Drug: Lixisenatide (AVE0010)
Subcutaneous injection

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus, diagnosed for at least 2 months at the time of screening visit, not treated by an antidiabetic agent in the 3 months before screening, except treatment with sulfonylureas or alpha-glucosidase inhibitors at a stable dose. In this case the OAD treatment must be discontinued before starting single-blind run-in phase.

Exclusion Criteria:

  • HbA1c <7% or >10%
  • Pregnant or breastfeeding women or women of childbearing potential with no effective contraceptive method
  • Type 2 diabetes treated by an antidiabetic pharmacological agent (except sulfonylurea or alpha-glucosidase inhibitors at a stable dose) within the three months preceding the screening.
  • Weight change of more than 5 kg during the 3 months preceding the study
  • Participation in any previous study with AVE0010
  • Use of any investigational drug within 3 months prior to study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905255

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00905255     History of Changes
Other Study ID Numbers: LTS10888
Study First Received: May 14, 2009
Last Updated: February 21, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
hyperglycemia
GLP-1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013