Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus

A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin

Primary Objective:

- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state

Secondary Objectives:

• To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
• To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
• To compare the occurrence of hypoglycemia between the 2 treatments;
• To assess the safety and tolerability of a new formulation of insulin glargine.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Drug: insulin glargine (HOE901); Drug: insulin glargine- new formulation (HOE901)

Detailed Description

66 days

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kumamoto-Shi, Japan
    • Investigational Site Number 392001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;

Exclusion criteria:

• Age < 20 years at written informed consent;
• HbA1c < 6.5% or > 10.0% at screening
• Diabetes mellitus (DM) other than T1DM;
• Body Mass Index (BMI) > 35.0 kg/m2 at screening visit
• Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
• Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal	Drug: insulin glargine (HOE901); Pharmaceutical form: solution Route of administration: subcutaneous; Drug: insulin glargine- new formulation (HOE901); Pharmaceutical form: solution Route of administration: subcutaneous
Experimental: Sequence 2; Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal	Drug: insulin glargine (HOE901); Pharmaceutical form: solution Route of administration: subcutaneous; Drug: insulin glargine- new formulation (HOE901); Pharmaceutical form: solution Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 24-hour blood glucose profile measured by continuous glucose monitoring	Baseline, Day 28, Day 56

Secondary Outcome Measures

Outcome Measure	Time Frame
Hypoglycemia categorized by the definition of American Diabetes Association	Up to Day 56
Change in fasting plasma glucose from baseline to each treatment end by treatment	Baseline, Day 28, Day 56
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment	Baseline, Day 28, Day 56
Change in HbA1c from baseline to each treatment end by treatment	Baseline, Day 28, Day 56

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• Jinnouchi H, Koyama M, Amano A, Takahashi Y, Yoshida A, Hieshima K, Sugiyama S, Kurinami N, Jinnouchi T, Becker R. Continuous Glucose Monitoring During Basal-Bolus Therapy Using Insulin Glargine 300 U mL(-1) and Glargine 100 U mL (-1) in Japanese People with Type 1 Diabetes Mellitus: A Crossover Pilot Study. Diabetes Ther. 2015 Jun;6(2):143-52. doi: 10.1007/s13300-015-0115-1. Epub 2015 Jun 9.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Estimate): August 19, 2013
• Last Update Submitted That Met QC Criteria: August 16, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: PDY12335; U1111-1129-3633 (Other Identifier: UTN)