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

Type 2 Diabetes Mellitus Clinical Trial

— EDITION JP II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689142
• Other study ID #: EFC12512
• Secondary ID: U1111-1130-3649
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2012
• Last updated: June 4, 2014
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: June 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
• Insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		baseline, 6 months	No
Secondary	Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)		up to 6 months	No
Secondary	Change from baseline in FPG		baseline, 6 months	No
Secondary	Change from baseline in pre-basal insulin injection SMPG		baseline, 6 months	No
Secondary	Change from baseline in 8-point SMPG profiles		baseline, 6 months	No
Secondary	Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)		baseline, 6 months	No
Secondary	Change from baseline in variability of plasma glucose profile		baseline, 6 months	No
Secondary	Change from baseline in daily basal insulin dose		baseline, 6 months	No
Secondary	Number of patients with various types of hypoglycemia events		up to 6 months	No