Clinical trial NCT01676233: Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Change in 24-hour blood glucose profile measured by continuous glucose monitoring
timeFrame: Baseline, Day 28, Day 56
Secondary outcomes:
measure: Hypoglycemia categorized by the definition of American Diabetes Association
timeFrame: Up to Day 56
measure: Change in fasting plasma glucose from baseline to each treatment end by treatment
timeFrame: Baseline, Day 28, Day 56
measure: Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment
timeFrame: Baseline, Day 28, Day 56
measure: Change in HbA1c from baseline to each treatment end by treatment
timeFrame: Baseline, Day 28, Day 56
Other outcomes:
Locations:
city: Kumamoto-Shi
country: Japan
facility: Investigational Site Number 392001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.