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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
insulin glargine (HOE901)
insulin glargine- new formulation (HOE901)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Arm Description

Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal

Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal

Outcomes

Primary Outcome Measures

Change in 24-hour blood glucose profile measured by continuous glucose monitoring

Secondary Outcome Measures

Hypoglycemia categorized by the definition of American Diabetes Association
Change in fasting plasma glucose from baseline to each treatment end by treatment
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Change in HbA1c from baseline to each treatment end by treatment

Full Information

First Posted
August 28, 2012
Last Updated
August 16, 2013
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01676233
Brief Title
Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
66 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Intervention Type
Drug
Intervention Name(s)
insulin glargine (HOE901)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
insulin glargine- new formulation (HOE901)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Change in 24-hour blood glucose profile measured by continuous glucose monitoring
Time Frame
Baseline, Day 28, Day 56
Secondary Outcome Measure Information:
Title
Hypoglycemia categorized by the definition of American Diabetes Association
Time Frame
Up to Day 56
Title
Change in fasting plasma glucose from baseline to each treatment end by treatment
Time Frame
Baseline, Day 28, Day 56
Title
Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
Time Frame
Baseline, Day 28, Day 56
Title
Change in HbA1c from baseline to each treatment end by treatment
Time Frame
Baseline, Day 28, Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392001
City
Kumamoto-Shi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26055218
Citation
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.
Results Reference
derived

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

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