Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus
NCT ID: NCT01676233
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2012-09-30
2013-08-31
Brief Summary
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\- 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
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal
insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
insulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Sequence 2
Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal
insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
insulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Interventions
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insulin glargine (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
insulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 392001
Kumamoto, , Japan
Countries
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References
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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.
Other Identifiers
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U1111-1129-3633
Identifier Type: OTHER
Identifier Source: secondary_id
PDY12335
Identifier Type: -
Identifier Source: org_study_id