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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1129-3633 | Other Identifier | UTN |
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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:
66 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal |
|
| Sequence 2 | Experimental | Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin glargine (HOE901) | Drug | Pharmaceutical form: solution Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour blood glucose profile measured by continuous glucose monitoring | Baseline, Day 28, Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 392001 | Kumamoto | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26055218 | Derived | 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. |
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| insulin glargine- new formulation (HOE901) | Drug | Pharmaceutical form: solution Route of administration: subcutaneous |
|
| 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 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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