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To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Insulin Glargine + Glimepiride + Metformin |
|
| 2 | Active Comparator | Insulin monotherapy with premixed insulin NPH 30/70 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | In the morning to target FBG ≤ 100 mg/dl |
| |
| Glimepiride |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % | At endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Change of fasting blood glucose | baseline to endpoint | |
| Change of nocturnal & mean daytime blood glucose | baseline to endpoint | |
| Change of fasting plasma glucose |
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Inclusion 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 |
|---|---|---|
| Christine Kliebe-Frisch, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi aventis administrative office | Vienna | Austria | ||||
| Sanofi-aventis administrative office |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C057619 | glimepiride |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
Glimepiride 3 or 4 mg |
|
| Metformin | Drug | At least 850 mg od |
|
| Insulin monotherapy with premixed insulin NPH 30/70 | Drug | Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl |
|
| baseline to endpoint and all visits |
| Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) | Baseline to endpoint |
| Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) | Baseline to endpoint |
| Frequency of subjects with FBG ≤ 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG ≤ 120 mg/dl (5.5 mmol/l < FBG ≤ 6.6 mmol/l), 120 mg/dl < FBG ≤ 150 mg/dl (6.6 mmol/l < FBG ≤ 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l) | At endpoint |
| Helsinki |
| Finland |
| Sanofi-aventis administrative office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Bromma | Sweden |
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |
| Sanofi-Aventis Administrative Office | Guildford | United Kingdom |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |