Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus (EDITION JP II)

June 4, 2014 updated by: Sanofi

A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period

Primary Objective:

To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in japanese patients with type 2 diabetes mellitus.

Secondary Objectives:

To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose (FPG), preinjection plasma glucose, 8-point self-measured plasma glucose (SMPG) profile.

To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of study will consist of:

  • Up to 2-week screening period;
  • 6-month open-label comparative efficacy and safety treatment period;
  • 6-month open-label comparative safety extension period;
  • 4-week post-treatment safety follow-up period

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Amagasaki-Shi, Japan
        • Investigational Site Number 392226
      • Chigasaki-Shi, Japan
        • Investigational Site Number 392218
      • Chiyoda-Ku, Japan
        • Investigational Site Number 392212
      • Chuo-Ku, Japan
        • Investigational Site Number 392209
      • Chuo-Ku, Japan
        • Investigational Site Number 392210
      • Chuoh-Ku, Japan
        • Investigational Site Number 392208
      • Ebina-Shi, Japan
        • Investigational Site Number 392217
      • Fujisawa-Shi, Japan
        • Investigational Site Number 392216
      • Higashiosaka-Shi, Japan
        • Investigational Site Number 392222
      • Izumisano-Shi, Japan
        • Investigational Site Number 392223
      • Kamakura-Shi, Japan
        • Investigational Site Number 392215
      • Kashiwara-Shi, Japan
        • Investigational Site Number 392225
      • Kawagoe-Shi, Japan
        • Investigational Site Number 392205
      • Kawaguchi-Shi, Japan
        • Investigational Site Number 392204
      • Kisarazu-Shi, Japan
        • Investigational Site Number 392206
      • Koriyama-Shi, Japan
        • Investigational Site Number 392201
      • Kurashiki-Shi, Japan
        • Investigational Site Number 392228
      • Matsuyama-Shi, Japan
        • Investigational Site Number 392229
      • Matsuyama-Shi, Japan
        • Investigational Site Number 392230
      • Mitaka-Shi, Japan
        • Investigational Site Number 392211
      • Nagoya-Shi, Japan
        • Investigational Site Number 392220
      • Nishinomiya-Shi, Japan
        • Investigational Site Number 392227
      • Ogawa-Machi, Hikigun, Japan
        • Investigational Site Number 392203
      • Okawa-Shi, Japan
        • Investigational Site Number 392231
      • Osaka-Shi, Japan
        • Investigational Site Number 392224
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392207
      • Shizuoka-Shi, Japan
        • Investigational Site Number 392219
      • Takatsuki-Shi, Japan
        • Investigational Site Number 392221
      • Ushiku-Shi, Japan
        • Investigational Site Number 392202
      • Yokohama-Shi, Japan
        • Investigational Site Number 392213
      • Yokohama-Shi, Japan
        • Investigational Site Number 392214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria :

o Patients with type 2 diabetes mellitus diagnosed for at least 1 year at the time of screening visit treated with basal insulin in combination with oral antihyperglycemic drugs (OADs) for at least 6 months before screening visit;

Exclusion criteria:

  • Age < 18 years at screening visit;
  • BMI(body mass index) ≥ 35 kg/m2 at screening visit;
  • HbA1c < 7.0% or > 10% (national glycohemoglobin standardization program [NGSP] value) at screening visit;
  • Diabetes other than type 2 diabetes mellitus;
  • Patients on self-monitoring of blood glucose less than 6 months before screening visit;
  • Patients using pre-mix insulins, insulin detemir at 2 times or more a day, or GLP 1 receptor agonists in the last 3 months before screening visit;
  • Patients using mealtime insulin (rapid-acting insulin analogue and short-acting insulin) for more than 10 days in the last 3 months before screening visit;
  • Use of insulin pump in the last 6 months before screening visit;
  • Initiation of new glucose-lowering medications and/or weight loss drugs in the last 3 months before screening visit;
  • Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit;
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New formulation of insulin glargine
once daily in the evening on-top of oral antihyperglycemic drug (OADs)
Drug: Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Active Comparator: Lantus (insulin glargine)
once daily in the evening on-top of OADs
Drug: Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Names:
  • Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c
Time Frame: baseline, 6 months
baseline, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
Time Frame: up to 6 months
up to 6 months
Change from baseline in FPG
Time Frame: baseline, 6 months
baseline, 6 months
Change from baseline in pre-basal insulin injection SMPG
Time Frame: baseline, 6 months
baseline, 6 months
Change from baseline in 8-point SMPG profiles
Time Frame: baseline, 6 months
baseline, 6 months
Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
Time Frame: baseline, 6 months
baseline, 6 months
Change from baseline in variability of plasma glucose profile
Time Frame: baseline, 6 months
baseline, 6 months
Change from baseline in daily basal insulin dose
Time Frame: baseline, 6 months
baseline, 6 months
Number of patients with various types of hypoglycemia events
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 14, 2012

First Submitted That Met QC Criteria

September 20, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

June 5, 2014

Last Update Submitted That Met QC Criteria

June 4, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC12512
  • U1111-1130-3649 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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