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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1116-2926 | Other Identifier | UTN |
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Primary Objective:
To evaluate the effect of prandial treatment adjustment, based on continuous blood glucose monitoring, on glucose control in type 2 diabetes patients who are not controlled by treatment with once daily basal insulin or mixed insulin, requiring treatment with basal plus regimen
The study duration for each patient is 24 weeks +/- 1 week broken down as follows:
The maximal possible time window during the study is +/- one week throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Without Continous Glucose Monitoring (CGM) sensor | Active Comparator | Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the treating physician |
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| Arm B: Continous Glucose Monitoring (CGM) sensor | Experimental | Run-in phase: insulin glargine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer . Treatment phase: the patients are connected to a CGM sensor. Insulin glulisine is administered at initial dosage according to FBG measurements performed by the patient by using a glucometer. Then, adjustment of the dosage is performed by the national coordinator based on the data collected in the past previous days of CGM sensor monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLARGINE (HOE901) | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Hemoglobin A1c (HbA1c) level | Baseline, week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hypoglycemia | Week 24 | |
| Changes in insulin glargine dose | Baseline, week 24 | |
| Changes in insulin glulisine dose |
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Inclusion criteria:
Run-in period:
Randomization:
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 376003 | Beersheba | Israel | ||||
| Investigational Site Number 376007 |
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| INSULIN GLULISINE (HMR1964) | Drug | Pharmaceutical form:Solution for injection Route of administration: Subcutaneous |
|
| Baseline, week 24 |
| Haifa |
| Israel |
| Investigational Site Number 376004 | Kfar Saba | 44281 | Israel |
| Investigational Site Number 376012 | Lod | Israel |
| Investigational Site Number 376013 | Nazareth | Israel |
| Investigational Site Number 376006 | Netanya | Israel |
| Investigational Site Number 376001 | Ramat Gan | Israel |
| Investigational Site Number 376009 | Sakhnin | Israel |
| Investigational Site Number 376008 | Tel Aviv | Israel |
| Investigational Site Number 376010 | Tel Aviv | Israel |
| Investigational Site Number 376011 | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C479079 | insulin glulisine |
| 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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