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CompletedNCT01676233Updated Aug 19, 2013

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 Phase 1 interventional study of insulin glargine (HOE901) and insulin glargine- new formulation (HOE901) in Type 1 Diabetes Mellitus, sponsored by Sanofi. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-08-19.

Sponsored by Sanofi · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.
Read the detailed description

66 days

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Browse Sanofi studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

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

  • Experimental
    Sequence 2

    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

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline, Day 28, Day 56

Secondary outcomes

  1. Hypoglycemia categorized by the definition of American Diabetes Association

    Time frame: Up to Day 56

  2. Change in fasting plasma glucose from baseline to each treatment end by treatment

    Time frame: Baseline, Day 28, Day 56

  3. Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment

    Time frame: Baseline, Day 28, Day 56

  4. Change in HbA1c from baseline to each treatment end by treatment

    Time frame: Baseline, Day 28, Day 56

07

Study locations

1 site
  • Investigational Site Number 392001
    Kumamoto, Japan
08

References and documents

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. PubMed 26055218 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2012, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2012
First posted
Aug 30, 2012
Start
Sep 2012
Primary completionActual
Aug 2013
CompletionActual
Aug 2013
Last update
Aug 19, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01676233
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Aug 30, 2012
Start date
Sep 2012
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Aug 19, 2013

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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