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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676233

U1111-1129-3633 (Other Identifier)

PDY12335

Details and patient eligibility

About

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.

Full description

66 days

Enrollment: 20 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: insulin glargine- new formulation (HOE901)

Drug: insulin glargine (HOE901)

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: insulin glargine- new formulation (HOE901)

Drug: insulin glargine (HOE901)