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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-2786 | Other Identifier | WHO |
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Primary Objective:
To demonstrate the non-inferiority of hemoglobin A1c (HbA1c) control at six months between the basal plus one and the biphasic insulin regimen.
Secondary Objective:
To demonstrate favorable outcome for basal plus over biphasic insulin when it comes to comparing when both hemoglobin A1c (HbA1c) target goal achievement and non-hypoglycemic event is taken into account.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1: Basal plus | Experimental | Insulin glargine with dosage adjustment determined according to the mean value of the last three days Fasting Blood Glucose (FBG) Insulin glulisine, at initial dosing of 4IU, then weekly adjusted according to the mean value of the last three days PostPrandial Blood Glucose (PPBG) |
|
| group 2: Biphasic insulin | Active Comparator | Insulin aspart/insulin aspart protamine 30/70 (novomix 30) given twice daily and titrated weekly (before breakfast and dinner) according to the lowest of three previous days' pre-meal levels (both breakfast and dinner). Target is 70 mg/dL < Pre-meal blood glucose (dinner and breakfast). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSULIN GLARGINE | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c level (HbA1c) | At 6 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hypoglycemic events (total, severe, nocturnal) | from baseline to the study endpoint (over 6 months of treatment) | |
| Proportion of patients with HbA1c < 7% | from baseline to the study endpoint (over 6 months of treatment) |
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Inclusion criteria:
Sub-optimally controlled Type 2 Diabetes Mellitus (T2DM) patients treated with insulin glargine for a minimum of 3 months:
Male or Female ≥18 years old
Body Mass Index (BMI) <40
10% ≥HbA1c ≥7%
If taking Oral anti-diabetics (OADs), must be on stable dose for at least 1 months
Patients willing to sign data release consent form
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 |
|---|---|---|---|---|---|---|
| Administrative Office | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25952532 | Derived | Jin SM, Kim JH, Min KW, Lee JH, Ahn KJ, Park JH, Jang HC, Park SW, Lee KW, Won KC, Kim YI, Chung CH, Park TS, Lee JH, Lee MK. Basal-prandial versus premixed insulin in patients with type 2 diabetes requiring insulin intensification after basal insulin optimization: A 24-week randomized non-inferiority trial. J Diabetes. 2016 May;8(3):405-13. doi: 10.1111/1753-0407.12312. Epub 2015 Jun 29. |
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| INSULIN GLULISINE | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily |
|
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| Insulin aspart | Drug | Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily |
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| Change in body weight | from baseline to the study endpoint (over 6 months of treatment) |
| Reactive Oxidative Stress (ROS) level changes | from baseline to the study endpoint (over 6 months of treatment) |
| Change in Quality of Life | from baseline to the study endpoint (over 6 months of treatment) |
| Continuous Glucose Monitoring System (CGMS) data | at baseline, 3 and 6 months |
| 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 |
| D061267 | Insulin Aspart |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| 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 |
| D061266 | Insulin, Short-Acting |
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