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Primary Objective:
>To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1: insulin glargine + insulin glulisine | Experimental | insulin glargine once daily + glulisine at meal times |
|
| group 2 NPH insulin + regular insulin | Active Comparator | NPH insulin (isophane insulin) (2 or more divided doses) + regular insulin at meal times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLARGINE | Drug | Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that reach the target of HbA1c ≤7% without confirmed nocturnal hypoglycaemia in each treatment group and the respective CI 90%. | From visit 1 (Day 1) to visit 13 (Day 169) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that reach the target of HbA1c ≤7% and proportion of patients reaching the target of Fasting Plasma Glucose (FPG ≤100mg/dL). | From baseline and Visit 13 (Day 169) | |
| Incidence of confirmed symptomatic and nocturnal hypoglycemias: plasma glucose measurement <= 70mg/dL. |
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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 076-007 | Curitiba | 80060-900 | Brazil | |||
| Investigational Site Number 076-010 |
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| NPH insulin (insulin isophane) | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia |
|
| INSULIN GLULISINE | Drug | Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia |
|
| Regular insulin | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia |
|
| From baseline and Visit 13 (Day 169) |
| Incidence of confirmed severe hypoglycemia: plasma glucose level < 36 mg/dL (2 mmol/L) or with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration | From baseline and Visit 13 (Day 169) |
| Weight variation | From baseline to the end of treatment at visit 13 (day 169) |
| Creatinine clearance variation | From baseline to the end of treatment at visit 13 (day 169) |
| Fortaleza |
| 60015-052 |
| Brazil |
| Investigational Site Number 076-001 | Fortaleza | 60115-282 | Brazil |
| Investigational Site Number 076-003 | Porto Alegre | 91350-250 | Brazil |
| Investigational Site Number 076-005 | São Paulo | 01244-030 | Brazil |
| Investigational Site Number 076-013 | São Paulo | 01308-050 | Brazil |
| Investigational Site Number 076-004 | São Paulo | 01323-001 | Brazil |
| Investigational Site Number 076-002 | São Paulo | 04024-002 | Brazil |
| Investigational Site Number 076-009 | São Paulo | o4039-000 | Brazil |
| Investigational Site Number 076-006 | Taguatinga | 72155000 | Brazil |
| 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 |
| D007336 | Insulin, Isophane |
| C479079 | insulin glulisine |
| D007328 | Insulin |
| 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 |
| D011384 | Proinsulin |
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