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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01689129
Other study ID # EFC12449
Secondary ID U1111-1130-3513
Status Completed
Phase Phase 3
First received September 14, 2012
Last updated June 6, 2014
Start date September 2012
Est. completion date April 2014

Study information

Verified date June 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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 1 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


Description:

The duration of study will consist of:

- Up to 2-week screening period;

- 6-month open-label comparative efficacy and safety treatment period;

- 6-month open-label comparative safety extension period;

- 4-week post-treatment safety follow-up period


Recruitment information / eligibility

Status Completed
Enrollment 243
Est. completion date April 2014
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Patients with type 1 diabetes mellitus

Exclusion criteria:

- Age < 18 years at screening visit;

- HbA1c < 7.0 % or > 10.0 % (national glycohemoglobin standardization program [NGSP] value) at screening visit;

- Patients less than 1 year before screening visit on any basal plus mealtime insulin;

- Patients not on stable insulin dose (±20% total basal insulin dose) in the last 30 days prior to screening visit;

- Patients using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime rapid-insulin analogue in the last 3 months before screening visit;

- Use of an insulin pump in the last 6 months before screening visit and/or plan to switch to insulin pump in next 12 months;

- 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 (eq, 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Insulin glargine new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Insulin glargine (HOE901) (Lantus)
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country Name City State
Japan Investigational Site Number 392119 Amagasaki-Shi
Japan Investigational Site Number 392106 Chuo-Ku
Japan Investigational Site Number 392107 Chuo-Ku
Japan Investigational Site Number 392110 Ebina-Shi
Japan Investigational Site Number 392115 Higashiosaka-Shi
Japan Investigational Site Number 392117 Izumisano-Shi
Japan Investigational Site Number 392109 Kamakura-Shi
Japan Investigational Site Number 392101 Koriyama-Shi
Japan Investigational Site Number 392121 Kurashiki-Shi
Japan Investigational Site Number 392112 Nagoya-Shi
Japan Investigational Site Number 392120 Nishinomiya-Shi
Japan Investigational Site Number 392113 Osaka-Shi
Japan Investigational Site Number 392116 Osaka-Shi
Japan Investigational Site Number 392118 Osaka-Shi
Japan Investigational Site Number 392104 Shinjuku-Ku
Japan Investigational Site Number 392105 Shinjuku-Ku
Japan Investigational Site Number 392111 Shizuoka-Shi
Japan Investigational Site Number 392114 Takatsuki-Shi
Japan Investigational Site Number 392122 Tokushima-Shi
Japan Investigational Site Number 392103 Tomioka-Shi
Japan Investigational Site Number 392102 Ushiku-Shi
Japan Investigational Site Number 392108 Yokohama-Shi

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c baseline, 6 months No
Secondary Percentage of HbA1c responders (HbA1c < 7%; < 6.5%) up to 6 months No
Secondary Change from baseline in FPG baseline, 6 months No
Secondary Change from baseline in pre-basal insulin injection SMPG baseline, 6 months No
Secondary Change from baseline in 8-point SMPG profiles baseline, 6 months No
Secondary Change from baseline in 24-hour mean plasma glucose of SMPG profiles (mean of 8-point values) baseline, 6 months No
Secondary Change from baseline in variability of plasma glucose profile baseline, 6 months No
Secondary Change from baseline in daily basal insulin dose baseline, 6 months No
Secondary Number of Patients with various types of Hypoglycemia Events up to 6 months No
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