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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01689142
First received: September 14, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Insulin glargine new formulation (HOE901)
Drug: Insulin glargine (HOE901)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus With a 6 Month Safety Extension Period

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of HbA1c responders (HbA1c < 7%; < 6.5%) [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in FPG [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in pre-basal insulin injection SMPG [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in 8-point SMPG profiles [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values) [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in variability of plasma glucose profile [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Change from baseline in daily basal insulin dose [ Time Frame: baseline, 6 months ] [ Designated as safety issue: No ]
  • Number of patients with various types of hypoglycemia events [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: September 2012
Study Completion Date: June 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lantus

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  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: NCT01689142

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

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01689142     History of Changes
Other Study ID Numbers: EFC12512, U1111-1130-3649
Study First Received: September 14, 2012
Last Updated: June 4, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glargine
Hypoglycemic Agents
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014