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

NCT ID: NCT01689142

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-06-30

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

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

New formulation of insulin glargine

once daily in the evening on-top of oral antihyperglycemic drug (OADs)

Group Type: EXPERIMENTAL

Insulin glargine new formulation (HOE901)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Lantus (insulin glargine)

once daily in the evening on-top of OADs

Group Type: ACTIVE_COMPARATOR

Insulin glargine (HOE901)

Intervention Type: DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Interventions

Insulin glargine new formulation (HOE901)

Pharmaceutical form: solution Route of administration: subcutaneous

Intervention Type: DRUG

Insulin glargine (HOE901)

Pharmaceutical form: solution Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Lantus

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 392226

Amagasaki-Shi, , Japan

Investigational Site Number 392218

Chigasaki-Shi, , Japan

Investigational Site Number 392212

Chiyoda-Ku, , Japan

Investigational Site Number 392208

Chuoh-Ku, , Japan

Investigational Site Number 392209

Chūōku, , Japan

Investigational Site Number 392210

Chūōku, , 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, , 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, , Japan

Investigational Site Number 392230

Matsuyama, , Japan

Investigational Site Number 392211

Mitaka-Shi, , Japan

Investigational Site Number 392220

Nagoya, , 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, , Japan

Investigational Site Number 392207

Shinjuku-Ku, , Japan

Investigational Site Number 392219

Shizuoka, , Japan

Investigational Site Number 392221

Takatsuki-Shi, , Japan

Investigational Site Number 392202

Ushiku-Shi, , Japan

Investigational Site Number 392213

Yokohama, , Japan

Investigational Site Number 392214

Yokohama, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 30160030 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26662838 (View on PubMed)

Other Identifiers

U1111-1130-3649

Identifier Type: OTHER

Identifier Source: secondary_id

EFC12512

Identifier Type: -

Identifier Source: org_study_id