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

NCT01689142 | Completed Phase 3

• 2 other identifiers: EFC12512U1111-1130-3649
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 31

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

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c

  baseline, 6 months

Secondary Outcomes (8)

• Percentage of HbA1c responders (HbA1c < 7%; < 6.5%)

  up to 6 months

• Change from baseline in FPG

  baseline, 6 months

• Change from baseline in pre-basal insulin injection SMPG

  baseline, 6 months

• Change from baseline in 8-point SMPG profiles

  baseline, 6 months

• Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values)

  baseline, 6 months

Study Arms (2)

New formulation of insulin glargine

EXPERIMENTAL

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

Drug: Insulin glargine new formulation (HOE901)

Lantus (insulin glargine)

ACTIVE COMPARATOR

once daily in the evening on-top of OADs

Drug: Insulin glargine (HOE901)

Interventions

Insulin glargine new formulation (HOE901) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

New formulation of insulin glargine

Insulin glargine (HOE901) DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Also known as: Lantus

Lantus (insulin glargine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (31)

Investigational Site Number 392226

Amagasaki-Shi, Japan

Location

Investigational Site Number 392218

Chigasaki-Shi, Japan

Location

Investigational Site Number 392212

Chiyoda-Ku, Japan

Location

Investigational Site Number 392208

Chuoh-Ku, Japan

Location

Investigational Site Number 392209

Chūōku, Japan

Location

Investigational Site Number 392210

Chūōku, Japan

Location

Investigational Site Number 392217

Ebina-Shi, Japan

Location

Investigational Site Number 392216

Fujisawa-Shi, Japan

Location

Investigational Site Number 392222

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392223

Izumisano, Japan

Location

Investigational Site Number 392215

Kamakura-Shi, Japan

Location

Investigational Site Number 392225

Kashiwara-Shi, Japan

Location

Investigational Site Number 392205

Kawagoe-Shi, Japan

Location

Investigational Site Number 392204

Kawaguchi-Shi, Japan

Location

Investigational Site Number 392206

Kisarazu-Shi, Japan

Location

Investigational Site Number 392201

Koriyama-Shi, Japan

Location

Investigational Site Number 392228

Kurashiki-Shi, Japan

Location

Investigational Site Number 392229

Matsuyama, Japan

Location

Investigational Site Number 392230

Matsuyama, Japan

Location

Investigational Site Number 392211

Mitaka-Shi, Japan

Location

Investigational Site Number 392220

Nagoya, Japan

Location

Investigational Site Number 392227

Nishinomiya-Shi, Japan

Location

Investigational Site Number 392203

Ogawa-Machi, Hikigun, Japan

Location

Investigational Site Number 392231

Okawa-Shi, Japan

Location

Investigational Site Number 392224

Osaka, Japan

Location

Investigational Site Number 392207

Shinjuku-Ku, Japan

Location

Investigational Site Number 392219

Shizuoka, Japan

Location

Investigational Site Number 392221

Takatsuki-Shi, Japan

Location

Investigational Site Number 392202

Ushiku-Shi, Japan

Location

Investigational Site Number 392213

Yokohama, Japan

Location

Investigational Site Number 392214

Yokohama, Japan

Location

Related Publications (2)

• 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.

  PMID: 30160030 DERIVED

• 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.

  PMID: 26662838 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 21, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2014
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

JP (31)