Not provided
Not provided
Not provided
Not provided
Not provided
Due to technical issues relating to the Electronic diary data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the change in hemoglobin A1c (HbA1c) from baseline to Week 12 between the 3 treatment arms.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulins + Sulfonylurea (SU) + Thiazolidinedione (TZD) | Experimental | Arm 1: Insulin glargine administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
|
| Insulins + Metformin (MET) + Thiazolidinedione (TZD) | Experimental | Arm 2: Insulin glargine administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
|
| Insulins + Metformin (MET) + Sulfonylurea (SU) | Experimental | Arm 3: Insulin glargine administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added arms after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Insulin glargine administered subcutaneously once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12 | 12 weeks from Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage | 60 weeks from Baseline | |
| Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5% | 60 weeks from Baseline |
Not provided
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrollment into the study:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Jean-Louis | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| sanofi-aventis, US | Bridgewater | New Jersey | 08807 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) | Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Insulin Glulisine | Drug | Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
|
| Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime) | 60 weeks from Baseline |
| Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions) | 60 weeks from Baseline |
| Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia |
| 60 weeks from Baseline |
| Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia |
| 60 Weeks from Baseline |
| Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) |
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
| FG002 | Insulin Glargine + Metformin (MET) + Sulfonylurea (SU) | Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SU + TZD + IG | Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%) |
| BG001 | MET + TZD + IG | Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%) |
| BG002 | MET+SU + IG | Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
| |||||||||||||||
| Duration of diabetes | Mean | Standard Deviation | years |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 | Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12 | Safety Population (excluding patients from Good Clinical Practice [GCP] non-compliant sites) | Posted | Mean | Standard Deviation | Percentage | 12 weeks from Baseline |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage | The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed. | Posted | Number | Percentage | 60 weeks from Baseline |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5% | The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed. | Posted | Mean | Standard Deviation | Percent | 60 weeks from Baseline |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime) | The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed. | Posted | Mean | Standard Deviation | Percentage | 60 weeks from Baseline |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions) | The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed. | Posted | Mean | Standard Deviation | mg/dL | 60 weeks from Baseline |
| ||||||||||||||||||||||||||||||||||
| Secondary | Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia |
| Safety Population | Posted | Number | Participants | 60 weeks from Baseline |
| ||||||||||||||||||||||||||||||||||
| Secondary | Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia |
| Safety Population | Posted | Mean | Standard Deviation | events/ patient-year | 60 Weeks from Baseline |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) | Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) | 22 | 128 | 99 | 128 | ||
| EG001 | Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) | Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) | 20 | 128 | 84 | 128 | ||
| EG002 | Insulin Glargine + Metformin (MET) + Sulfonylurea (SU) | Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) | 13 | 130 | 84 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Angina unstable | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve stenosis | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Cardio-respiratory arrest | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery occlusion | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest Discomfort | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Drug hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Scrotal abscess | Infections and infestations | Systematic Assessment |
| ||
| Burns second degree | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Bone cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Hypoglycaemic coma | Nervous system disorders | Systematic Assessment |
| ||
| Myelitis transverse | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Aortic stenosis | Vascular disorders | Systematic Assessment |
| ||
| Arterial stenosis | Vascular disorders | Systematic Assessment |
| ||
| Arteriosclerosis | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypertensive crisis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Weight increased | Investigations | Systematic Assessment |
| ||
| Edema Peripheral | General disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs study director | sanofi-aventis | publicregistryUSMA@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 |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
|
|
|
|
| OG002 |
| Insulin Glargine + Metformin (MET) + Sulfonylurea (SU) |
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
|
|
| OG002 | Insulin Glargine + Metformin (MET) + Sulfonylurea (SU) | Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) |
|
|