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Comparison of a New Formulation of Insulin Glargine With Lantus® in Japanese Patients With Type 1 Diabetes Mellitus (EDITION JP I)

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ClinicalTrials.gov Identifier: NCT01689129
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

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


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin glargine new formulation (HOE901) Drug: Insulin glargine (HOE901) (Lantus) Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period
Study Start Date : September 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: New formulation of insulin glargine
once daily in the evening on-top of mealtime insulin
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 mealtime insulin
Drug: Insulin glargine (HOE901) (Lantus)
Pharmaceutical form: solution Route of administration: subcutaneous
Other Name: Lantus




Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: baseline, 6 months ]

Secondary Outcome Measures :
  1. Percentage of HbA1c responders (HbA1c < 7%; < 6.5%) [ Time Frame: up to 6 months ]
  2. Change from baseline in FPG [ Time Frame: baseline, 6 months ]
  3. Change from baseline in pre-basal insulin injection SMPG [ Time Frame: baseline, 6 months ]
  4. Change from baseline in 8-point SMPG profiles [ Time Frame: baseline, 6 months ]
  5. Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values) [ Time Frame: baseline, 6 months ]
  6. Change from baseline in variability of plasma glucose profile [ Time Frame: baseline, 6 months ]
  7. Change from baseline in daily basal insulin dose [ Time Frame: baseline, 6 months ]
  8. Number of Patients with various types of Hypoglycemia Events [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with type 1 diabetes mellitus

Exclusion criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689129


Locations
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Japan
Investigational Site Number 392119
Amagasaki-Shi, Japan
Investigational Site Number 392106
Chuo-Ku, Japan
Investigational Site Number 392107
Chuo-Ku, Japan
Investigational Site Number 392110
Ebina-Shi, Japan
Investigational Site Number 392115
Higashiosaka-Shi, Japan
Investigational Site Number 392117
Izumisano-Shi, Japan
Investigational Site Number 392109
Kamakura-Shi, Japan
Investigational Site Number 392101
Koriyama-Shi, Japan
Investigational Site Number 392121
Kurashiki-Shi, Japan
Investigational Site Number 392112
Nagoya-Shi, Japan
Investigational Site Number 392120
Nishinomiya-Shi, Japan
Investigational Site Number 392113
Osaka-Shi, Japan
Investigational Site Number 392116
Osaka-Shi, Japan
Investigational Site Number 392118
Osaka-Shi, Japan
Investigational Site Number 392104
Shinjuku-Ku, Japan
Investigational Site Number 392105
Shinjuku-Ku, Japan
Investigational Site Number 392111
Shizuoka-Shi, Japan
Investigational Site Number 392114
Takatsuki-Shi, Japan
Investigational Site Number 392122
Tokushima-Shi, Japan
Investigational Site Number 392103
Tomioka-Shi, Japan
Investigational Site Number 392102
Ushiku-Shi, Japan
Investigational Site Number 392108
Yokohama-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01689129     History of Changes
Other Study ID Numbers: EFC12449
U1111-1130-3513 ( Other Identifier: UTN )
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: June 9, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs