NCT01676233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

August 28, 2012

Last Update Submit

August 16, 2013

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Day 28, Day 56

Secondary Outcomes (4)

  • 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

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

Drug: insulin glargine (HOE901)Drug: insulin glargine- new formulation (HOE901)

Sequence 2

EXPERIMENTAL

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

Drug: insulin glargine (HOE901)Drug: insulin glargine- new formulation (HOE901)

Interventions

insulin glargine (HOE901)DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Sequence 1Sequence 2
insulin glargine- new formulation (HOE901)DRUG

Pharmaceutical form: solution Route of administration: subcutaneous

Sequence 1Sequence 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site Number 392001

Kumamoto, Japan

Location

Related Publications (1)

  • 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.

    PMID: 26055218DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

JP(1)