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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT # : 2005-002614-38 |
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To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin glulisine+insulin glargine+metformin+glimepiride | Other | Bolus arm |
|
| insulin glargine+metformin+glimepiride | Other | Control arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | One daily injection at bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% | Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7% | at the end of treatment (week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycosylated Haemoglobin (HbA1c) Value | at the end of treatment (week 24) | |
| Change in Glycosylated Haemoglobin (HbA1c) Value | from baseline to the end of treatment (week 24) | |
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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 |
|---|---|---|
| PILORGET Valérie, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-aventis | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis |
During Run-In period patients were not assigned to a treatment group. They were all treated with Insulin Glargine + Metformin + Glimepiride.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride | Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) |
| FG001 | Insulin Glargine+Metformin+Glimepiride | Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-In |
|
| |||||||||||||||||||||
| Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride | Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% | Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7% | Modified Intent to treat (ITT) population, LOCF (Last Observation Carried Forward) | Posted | Number | percentage of participants | at the end of treatment (week 24) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride | Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 8 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs study director | sanofi-aventis | publicregistryGMA@sanofi-aventis.com |
| 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 |
| C479079 | insulin glulisine |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Glimepiride | Drug | At same dosage as during the run-in period |
|
| Insulin Glulisine | Drug | One bolus given before the main meal |
|
| Metformin | Drug | At same dosage as during the run-in period |
|
| Daily Mean Plasma Glucose |
| at the end of treatment (week 24) |
| Change in Daily Mean Plasma Glucose | from baseline to the end of treatment (week 24) |
| Change in Weight | from baseline to the end of treatment (week 24) |
| Daily Dose of Insulin Glargine | Mean of 3 daily doses reported during the week prior to the final visit | at the end of treatment (week 24) |
| Daily Dose of Insulin Glulisine | Mean of 3 daily doses reported during the week prior to the final visit | at the end of treatment (week 24) |
| Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL | during treatment period (12 weeks) |
| Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL | during treatment period (12 weeks) |
| Rate of Severe Symptomatic Hypoglycemia | during treatment period (12 weeks) |
| Moscow |
| Russia |
| Sanofi-aventis | Guildford | United Kingdom |
| Non compliance with treatment procedure |
|
| Sponsor request |
|
| Patient did not meet inclusion criteria |
|
| Patient personal reasons |
|
| Need of insulin with meals |
|
| NOT COMPLETED |
|
|
| Insulin Glargine+Metformin+Glimepiride |
Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Total patients analyzed n=105 due to one missing data in the "insulin glulisine+insulin glargine+metformin+glimepiride" group | Mean | Standard Deviation | kg/m² |
|
| Daily Mean Plasma Glucose | Patients having a baseline value and a value on treatment: insulin glulisine+insulin glargine+metformin+glimepiride group n=47 patients, insulin glargine+metformin+glimepiride group n=55 patients | Mean | Standard Deviation | mg/dL |
|
| Duration of diabetes | Mean | Standard Deviation | years |
|
| Glycosylated Haemoglobin (HbA1c) | Mean | Standard Deviation | percent |
|
| Weight | Total patients analyzed n=105 due to one missing data in the "insulin glulisine+insulin glargine+metformin+glimepiride" group | Mean | Standard Deviation | kg |
|
| OG001 | Insulin Glargine+Metformin+Glimepiride | Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) |
|
|
|
| Secondary | Glycosylated Haemoglobin (HbA1c) Value | Modified ITT population, LOCF | Posted | Mean | Standard Deviation | percent | at the end of treatment (week 24) |
|
|
|
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) Value | Modified ITT population, LOCF | Posted | Least Squares Mean | Standard Error | percent | from baseline to the end of treatment (week 24) |
|
|
|
|
| Secondary | Daily Mean Plasma Glucose | Modified ITT population, LOCF | Posted | Mean | Standard Deviation | mg/dL | at the end of treatment (week 24) |
|
|
|
| Secondary | Change in Daily Mean Plasma Glucose | Modified ITT population, LOCF | Posted | Least Squares Mean | Standard Error | mg/dL | from baseline to the end of treatment (week 24) |
|
|
|
|
| Secondary | Change in Weight | Modified ITT population, LOCF | Posted | Least Squares Mean | Standard Error | kg | from baseline to the end of treatment (week 24) |
|
|
|
|
| Secondary | Daily Dose of Insulin Glargine | Mean of 3 daily doses reported during the week prior to the final visit | Modified ITT population, LOCF | Posted | Mean | Standard Deviation | units of insulin glargine per day | at the end of treatment (week 24) |
|
|
|
| Secondary | Daily Dose of Insulin Glulisine | Mean of 3 daily doses reported during the week prior to the final visit | Modified ITT population, LOCF | Posted | Mean | Standard Deviation | units of insulin glulisine per day | at the end of treatment (week 24) |
|
|
|
| Secondary | Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL | Safety population | Posted | Mean | Standard Deviation | Number of hypoglycemia per patient-year | during treatment period (12 weeks) |
|
|
|
|
| Secondary | Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL | Safety population | Posted | Mean | Standard Deviation | Number of hypoglycemia per patient-year | during treatment period (12 weeks) |
|
|
|
|
| Secondary | Rate of Severe Symptomatic Hypoglycemia | Safety population | Posted | Mean | Standard Deviation | Number of hypoglycemia per patient-year | during treatment period (12 weeks) |
|
|
|
|
| 1 |
| 49 |
| 0 |
| 49 |
| EG001 | Insulin Glargine+Metformin+Glimepiride | Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period) | 2 | 57 | 0 | 57 |
| Tendon Disorder | Musculoskeletal and connective tissue disorders | MedDRA 8 | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA 8 | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 8 | Non-systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| 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 |
| Superiority or Other |
| No |
| Superiority or Other |
| Superiority or Other |