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The primary objectives were:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lantus/Apidra-3 | Experimental | Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. |
|
| Lantus/Apidra-1 | Experimental | Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. |
|
| Novolog Mix 70/30 | Experimental | Premixed insulin (Novolog® Mix 70/30) added to oral agents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glulisine | Drug | Subcutaneous injection up to 1 injection per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites) | Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders. | At week 60 |
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population | Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol. | At week 60 |
| Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis) | Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders. | At week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30) | Absolute Change in HbA1c from Baseline to Week 60. | From baseline to week 60 |
| Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30) |
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24919603 | Derived | Polonsky WH, Thompson S, Wei W, Riddle MC, Chaudhari S, Jackson J, Bruno AS. Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study. Diabetes Obes Metab. 2014 Nov;16(11):1121-7. doi: 10.1111/dom.12328. Epub 2014 Jul 12. |
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Patient were considered enrolled after informed consent were obtained, and randomized after completion of the 4-week run-in phase and assessment of the randomization criteria.
A total of 123 study sites were activated in the United States; 99 sites enrolled and randomized 588 patients from May 2006 to March 2010. 582 patients out of 588 patients were treated. Three sites (which included 26 patients) were found to be non Good Clinical Practices (GCP) compliant.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lantus/Apidra-3 | Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. |
| FG001 | Lantus/Apidra-1 | Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. |
| FG002 | Novolog Mix 70/30 | Premixed insulin (Novolog® Mix 70/30) added to oral agents. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lantus/Apidra-3 | Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. |
| BG001 | Lantus/Apidra-1 | Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. |
| 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 | Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites) | Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders. | Analysis was performed on Intent-To-Treat population which consisted of all patients who were randomized and for whom there was any post-baseline follow-up information. Patients from nonGCP compliant sites were excluded from this analysis. Additional analysis including those patients were completed to ensure that study results were not compromised. | Posted | Number | percentage of participants | At week 60 |
|
All Adverse Events (AE) regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent Form up to the last visit were collected.
The analysis was performed on the exposed population (i.e. safety population) and included all AE that developed/worsened during the 'on-treatment period' (i.e. from randomization up to 24 hours after treatment discontinuation or final follow-up visit, whichever came first) regardless of enrollment in a non-GCP compliant site.
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 | Lantus/Apidra-3 | Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any gastrointestinal disorders | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | sanofi-aventis | Contact-US@sanofi-aventis.com |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D000069036 | Insulin Glargine |
| C557564 | insulin aspart, insulin aspart protamine drug combination 30:70 |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
Not provided
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| Insulin Glargine | Drug | Subcutaneous injection once-a-day |
|
|
| Premixed Insulin | Drug | Subcutaneous injection twice-a-day. |
|
|
| Insulin Glulisine | Drug | Subcutaneous injection up to 3 injections per day. |
|
|
Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders. |
| At week 60 |
| Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl | Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration. A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms. | At week 60 |
| Adjusted Incidence Rate of Hypoglycemia | Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia. A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event. A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion. Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock. An event is included if the HE start date is within the treatment period. | Week 60 |
| Adjusted Hypoglycemic Event Rates (Event/Patient-year) | Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study. An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug). | Week 60 |
| No longer Requires Study Treatment |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Progressive Disease |
|
| Withdrawal by Subject |
|
| Patient non-compliant |
|
| Physician Decision |
|
| Loss of site personnel |
|
| Sponsor decision |
|
| Patient moved |
|
| Patient required surgery |
|
| BG002 | Novolog Mix 70/30 | Premixed insulin (Novolog® Mix 70/30) added to oral agents. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilogram/m^2 |
|
| Duration of diabetes at study entry | Mean | Standard Deviation | years |
|
| Age at onset of diabetes | Mean | Standard Deviation | years |
|
| Oral antidiabetic treatment combination at study entry | Number | participants |
|
Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
| OG001 | Novolog Mix 70/30 | Premixed insulin (Novolog® Mix 70/30) added to oral agents. |
|
|
|
| Primary | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population | Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol. | Analysis was performed on the Per Protocol (PP) population which included randomized patients who had no major protocol violation and who had HbA1c recorded for both Baseline & Week 60. Patients from non-GCP compliant sites were, by population definition, excluded from this analysis. | Posted | Least Squares Mean | Standard Error | percent HbA1c | At week 60 |
|
|
|
|
| Primary | Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis) | Responders defined as patients who achieved an HbA1c value <7.0% versus nonresponders. Patients who did not achieve an HbA1c value <7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders. | Analysis was performed on the Intent To Treat (ITT) population which consisted of all patients who were randomized, and for whom there was any post-baseline follow-up information. Patients from non-GCP compliant sites were included in this analysis. This analysis was performed to ensure that study results were not compromised. | Posted | Number | percentage of participants | At week 60 |
|
|
|
|
| Secondary | Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30) | Absolute Change in HbA1c from Baseline to Week 60. | Analysis was performed on the modified ITT (mITT) population which consisted of all patients who were randomized, and for whom there was a baseline observation and at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3 & 7 from Novolog Mix arms) were excluded from this analysis. | Posted | Least Squares Mean | Standard Error | percent HbA1c | From baseline to week 60 |
|
|
|
|
| Secondary | Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30) | Patients who achieved an HbA1c value <7.0% were defined as responders. Patients who did not achieve HbA1c values <7.0% and patients with missing HbA1c values were considered nonresponders. | Analysis was performed on the modified intent-to-treat population which consisted of all patients who were randomized & for whom there was a baseline observation & at least 1 postbaseline (on therapy) observation for HbA1c. Patients from non-GCP compliant sites (9 for Lantus/Apidra-1 & 7 for Novolog Mix arms) were excluded from this analysis. | Posted | Number | percentage of participants | At week 60 |
|
|
|
|
| Secondary | Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl | Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration. A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of <50 mg/dL with reported symptoms. | Analysis was performed on the mITT population. Patients from non-GCP compliant sites (8 from Lantus/Apidra-3, 9 from Lantus/Apidra-1 & 7 from Novolog Mix arms) were excluded from this analysis. | Posted | Number | percentage of participants | At week 60 |
|
|
|
|
| Secondary | Adjusted Incidence Rate of Hypoglycemia | Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia. A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) <36 mg/dL during or soon after the event. A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion. Nocturnal = events occurring between 00:00 & 06:00 based on a 24-hour clock. An event is included if the HE start date is within the treatment period. | The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site. | Posted | Mean | Standard Error | estimated percentage per patient | Week 60 |
|
|
|
| Secondary | Adjusted Hypoglycemic Event Rates (Event/Patient-year) | Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study. An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to & including 1 day after the date of last dose of study drug). | The analysis was performed on the exposed population (i.e. safety population) regardless of enrollment in a non-GCP compliant site. | Posted | Mean | Standard Error | event per patient year | Week 60 |
|
|
|
| 22 |
| 194 |
| 140 |
| 194 |
| EG001 | Lantus/Apidra-1 | Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents. | 23 | 194 | 150 | 194 |
| EG002 | Novolog Mix 70/30 | Premixed insulin (Novolog® Mix 70/30) added to oral agents. | 21 | 194 | 152 | 194 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Faecalith | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Gallbladder abscess | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Bone neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Diabetic coma | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Schizoaffective disorder | Psychiatric disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Stress urinary incontinence | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Any general disorders and administration site conditions | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Any infections and infestations | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Any musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Any nervous system disorders | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Any respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | 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 |
| Missing data |
|
| Title | Measurements |
|---|---|
|
| Missing data |
|
| Adjusted Odds Ratio |
| 2.11 |
| 2-Sided |
| 95 |
| 1.19 |
| 3.73 |
| No |
| Superiority or Other |
| Regression, Logistic | 0.0121 | Adjusted Odds Ratio | 2.06 | 2-Sided | 95 | 1.17 | 3.61 | No | Superiority or Other |
|
| SMBG< 70 mg/dl, nocturnal |
|
| SMBG< 70 mg/dl with symptoms, nocturnal |
|
| SMBG< 50 mg/dl |
|
| SMBG< 50 mg/dl with symptoms |
|
| SMBG< 50 mg/dl, nocturnal |
|
| SMBG< 50 mg/dl with symptoms, nocturnal |
|
| SMBG< 36 mg/dl |
|
| Severe hypoglycemias |
|
| Serious hypoglycemias |
|
|
| SMBG< 70 mg/dl, nocturnal |
|
| SMBG< 70 mg/dl with symptoms, nocturnal |
|
| SMBG< 50 mg/dl |
|
| SMBG< 50 mg/dl with symptoms |
|
| SMBG< 50 mg/dl, nocturnal |
|
| SMBG< 50 mg/dl with symptoms, nocturnal |
|
| SMBG< 36 mg/dl |
|
| Severe hypoglycemias |
|
| Serious hypoglycemias |
|