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

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: insulin glargine (HOE901); Drug: insulin glargine- new formulation (HOE901)

• Registration Number: NCT01676233
• Lead Sponsor: Sanofi

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

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Study Start: 2012-09
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	insulin glargine (HOE901)	Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Sequence 1	insulin glargine- new formulation (HOE901)	Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
Sequence 2	insulin glargine (HOE901)	Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
Sequence 2	insulin glargine- new formulation (HOE901)	Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal

Primary Outcome Measures

Name	Time	Method
Change in 24-hour blood glucose profile measured by continuous glucose monitoring	Baseline, Day 28, Day 56

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site Number 392001; 🇯🇵 Kumamoto-Shi, Japan