NCT01689129

Brief Summary

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 1 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
243

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

September 14, 2012

Last Update Submit

June 6, 2014

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c

    baseline, 6 months

Secondary Outcomes (8)

  • Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)

    up to 6 months

  • Change from baseline in FPG

    baseline, 6 months

  • Change from baseline in pre-basal insulin injection SMPG

    baseline, 6 months

  • Change from baseline in 8-point SMPG profiles

    baseline, 6 months

  • Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)

    baseline, 6 months

  • +3 more secondary outcomes

Study Arms (2)

New formulation of insulin glargine

EXPERIMENTAL

once daily in the evening on-top of mealtime insulin

Drug: Insulin glargine new formulation (HOE901)

Lantus (insulin glargine)

ACTIVE COMPARATOR

once daily in the evening on-top of mealtime insulin

Drug: Insulin glargine (HOE901) (Lantus)

Interventions

Insulin glargine new formulation (HOE901)DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

New formulation of insulin glargine
Insulin glargine (HOE901) (Lantus)DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: Lantus
Lantus (insulin glargine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 1 diabetes mellitus

You may not qualify if:

  • Age \< 18 years at screening visit;
  • HbA1c \< 7.0 % or \> 10.0 % (national glycohemoglobin standardization program \[NGSP\] value) at screening visit;
  • Patients less than 1 year before screening visit on any basal plus mealtime insulin;
  • Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;
  • Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;
  • Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;
  • 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 (eq, 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Investigational Site Number 392119

Amagasaki-Shi, Japan

Location

Investigational Site Number 392106

Chūōku, Japan

Location

Investigational Site Number 392107

Chūōku, Japan

Location

Investigational Site Number 392110

Ebina-Shi, Japan

Location

Investigational Site Number 392115

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392117

Izumisano, Japan

Location

Investigational Site Number 392109

Kamakura-Shi, Japan

Location

Investigational Site Number 392101

Koriyama-Shi, Japan

Location

Investigational Site Number 392121

Kurashiki-Shi, Japan

Location

Investigational Site Number 392112

Nagoya, Japan

Location

Investigational Site Number 392120

Nishinomiya-Shi, Japan

Location

Investigational Site Number 392113

Osaka, Japan

Location

Investigational Site Number 392116

Osaka, Japan

Location

Investigational Site Number 392118

Osaka, Japan

Location

Investigational Site Number 392104

Shinjuku-Ku, Japan

Location

Investigational Site Number 392105

Shinjuku-Ku, Japan

Location

Investigational Site Number 392111

Shizuoka, Japan

Location

Investigational Site Number 392114

Takatsuki-Shi, Japan

Location

Investigational Site Number 392122

Tokushima, Japan

Location

Investigational Site Number 392103

Tomioka-Shi, Japan

Location

Investigational Site Number 392102

Ushiku-Shi, Japan

Location

Investigational Site Number 392108

Yokohama, Japan

Location

Related Publications (1)

  • Matsuhisa M, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T; EDITION JP 1 study group. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese adults with type 1 diabetes using basal and mealtime insulin: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 1). Diabetes Obes Metab. 2016 Apr;18(4):375-83. doi: 10.1111/dom.12619. Epub 2016 Feb 1.

    PMID: 26662964DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

September 21, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

June 9, 2014

Record last verified: 2014-06

Locations

JP(22)