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

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676233
• Other study ID #: PDY12335
• Secondary ID: U1111-1129-3633
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2012
• Last updated: August 16, 2013
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• 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 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.

Description:

66 days

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
• insulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Japan	Investigational Site Number 392001	Kumamoto-Shi

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour blood glucose profile measured by continuous glucose monitoring		Baseline, Day 28, Day 56	No
Secondary	Hypoglycemia categorized by the definition of American Diabetes Association		Up to Day 56	Yes
Secondary	Change in fasting plasma glucose from baseline to each treatment end by treatment		Baseline, Day 28, Day 56	No
Secondary	Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment		Baseline, Day 28, Day 56	No
Secondary	Change in HbA1c from baseline to each treatment end by treatment		Baseline, Day 28, Day 56	No