Clinical trial NCT01689142: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

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 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.

Primary outcomes:
measure: Change from baseline in HbA1c
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)
timeFrame: up to 6 months
measure: Change from baseline in FPG
timeFrame: baseline, 6 months
measure: Change from baseline in pre-basal insulin injection SMPG
timeFrame: baseline, 6 months
measure: Change from baseline in 8-point SMPG profiles
timeFrame: baseline, 6 months
measure: Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)
timeFrame: baseline, 6 months
measure: Change from baseline in variability of plasma glucose profile
timeFrame: baseline, 6 months
measure: Change from baseline in daily basal insulin dose
timeFrame: baseline, 6 months
measure: Number of patients with various types of hypoglycemia events
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Amagasaki-Shi
country: Japan
facility: Investigational Site Number 392226
city: Chigasaki-Shi
country: Japan
facility: Investigational Site Number 392218
city: Chiyoda-Ku
country: Japan
facility: Investigational Site Number 392212
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392209
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392210
city: Chuoh-Ku
country: Japan
facility: Investigational Site Number 392208
city: Ebina-Shi
country: Japan
facility: Investigational Site Number 392217
city: Fujisawa-Shi
country: Japan
facility: Investigational Site Number 392216
city: Higashiosaka-Shi
country: Japan
facility: Investigational Site Number 392222
city: Izumisano-Shi
country: Japan
facility: Investigational Site Number 392223
city: Kamakura-Shi
country: Japan
facility: Investigational Site Number 392215
city: Kashiwara-Shi
country: Japan
facility: Investigational Site Number 392225
city: Kawagoe-Shi
country: Japan
facility: Investigational Site Number 392205
city: Kawaguchi-Shi
country: Japan
facility: Investigational Site Number 392204
city: Kisarazu-Shi
country: Japan
facility: Investigational Site Number 392206
city: Koriyama-Shi
country: Japan
facility: Investigational Site Number 392201
city: Kurashiki-Shi
country: Japan
facility: Investigational Site Number 392228
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392229
city: Matsuyama-Shi
country: Japan
facility: Investigational Site Number 392230
city: Mitaka-Shi
country: Japan
facility: Investigational Site Number 392211
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392220
city: Nishinomiya-Shi
country: Japan
facility: Investigational Site Number 392227
city: Ogawa-Machi, Hikigun
country: Japan
facility: Investigational Site Number 392203
city: Okawa-Shi
country: Japan
facility: Investigational Site Number 392231
city: Osaka-Shi
country: Japan
facility: Investigational Site Number 392224
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392207
city: Shizuoka-Shi
country: Japan
facility: Investigational Site Number 392219
city: Takatsuki-Shi
country: Japan
facility: Investigational Site Number 392221
city: Ushiku-Shi
country: Japan
facility: Investigational Site Number 392202
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392213
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392214
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Bolli GB, Wysham C, Fisher M, Chevalier S, Cali AMG, Leroy B, Riddle MC. A post-hoc pooled analysis to evaluate the risk of hypoglycaemia with insulin glargine 300 U/mL (Gla-300) versus 100 U/mL (Gla-100) over wider nocturnal windows in individuals with type 2 diabetes on a basal-only insulin regimen. Diabetes Obes Metab. 2019 Feb;21(2):402-407. doi: 10.1111/dom.13515. Epub 2018 Oct 2.
citation: Terauchi Y, Koyama M, Cheng X, Takahashi Y, Riddle MC, Bolli GB, Hirose T. New insulin glargine 300 U/ml versus glargine 100 U/ml in Japanese people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: glucose control and hypoglycaemia in a randomized controlled trial (EDITION JP 2). Diabetes Obes Metab. 2016 Apr;18(4):366-74. doi: 10.1111/dom.12618. Epub 2016 Jan 21.