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This trial is conducted in Asia, South America and the United States of America (USA).
The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDet | Experimental | Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day |
|
| IGlar | Active Comparator | Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline | Week 0, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% | Week 26 |
| Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Litchfield Park | Arizona | 85340 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23421331 | Result | Meneghini L, Kesavadev J, Demissie M, Nazeri A, Hollander P. Once-daily initiation of basal insulin as add-on to metformin: a 26-week, randomized, treat-to-target trial comparing insulin detemir with insulin glargine in patients with type 2 diabetes. Diabetes Obes Metab. 2013 Aug;15(8):729-36. doi: 10.1111/dom.12083. Epub 2013 Mar 13. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
After randomisation, the dose and dosing frequency of metformin were maintained throughout the trial in both treatment arms. Other oral anti-diabetic drug (OAD) was discontinued before use of trial product
There were a total of 85 trial sites in 5 countries: 70 in the United States of America (USA), 5 in Thailand, 4 in Korea, 2 in India and 4 in Argentina
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IDet | Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day |
| FG001 | IGlar | Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| insulin glargine | Drug | Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued |
|
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. |
| Week 26 |
| Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less | Week 26 |
| Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. | Week 26 |
| Fasting Plasma Glucose (FPG) | Week 26 |
| Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. | Week 26 |
| Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. | Week 26 |
| Incidence of Hypoglycaemic Episodes During the Trial | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Weeks 0-26 |
| Hypoglycaemic Episodes, Diurnal | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Weeks 0-26 |
| Hypoglycaemic Episodes, Nocturnal | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Weeks 0-26 |
| Hypoglycemic Episodes, Unclassifiable | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Weeks 0-26 |
| Change in Body Weight From Baseline | Week 0, Week 26 |
| Number of Subjects Having the Adverse Event "Incorrect Dose Administered" | Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications" | Weeks 0-26 |
| Searcy |
| Arkansas |
| 72143 |
| United States |
| Novo Nordisk Investigational Site | Anaheim | California | 92801 | United States |
| Novo Nordisk Investigational Site | Concord | California | 94520 | United States |
| Novo Nordisk Investigational Site | Escondido | California | 92025 | United States |
| Novo Nordisk Investigational Site | Fresno | California | 93720 | United States |
| Novo Nordisk Investigational Site | Long Beach | California | 90822 | United States |
| Novo Nordisk Investigational Site | Los Angeles | California | 90057 | United States |
| Novo Nordisk Investigational Site | Redlands | California | 92374 | United States |
| Novo Nordisk Investigational Site | Santa Ana | California | 92705 | United States |
| Novo Nordisk Investigational Site | Spring Valley | California | 91978 | United States |
| Novo Nordisk Investigational Site | Aurora | Colorado | 80045 | United States |
| Novo Nordisk Investigational Site | Norwalk | Connecticut | 06851 | United States |
| Novo Nordisk Investigational Site | Hollywood | Florida | 33021 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32204 | United States |
| Novo Nordisk Investigational Site | Jacksonville | Florida | 32207 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33136 | United States |
| Novo Nordisk Investigational Site | Miami | Florida | 33143 | United States |
| Novo Nordisk Investigational Site | Ocala | Florida | 34471 | United States |
| Novo Nordisk Investigational Site | Orlando | Florida | 32804 | United States |
| Novo Nordisk Investigational Site | Plantation | Florida | 33324 | United States |
| Novo Nordisk Investigational Site | Ponte Vedra | Florida | 32081 | United States |
| Novo Nordisk Investigational Site | Winter Haven | Florida | 33880 | United States |
| Novo Nordisk Investigational Site | Powder Springs | Georgia | 30127 | United States |
| Novo Nordisk Investigational Site | Roswell | Georgia | 30076 | United States |
| Novo Nordisk Investigational Site | Idaho Falls | Idaho | 83404-7596 | United States |
| Novo Nordisk Investigational Site | Independence | Kansas | 67301-3263 | United States |
| Novo Nordisk Investigational Site | Shawnee Mission | Kansas | 66204 | United States |
| Novo Nordisk Investigational Site | Portland | Maine | 04101 | United States |
| Novo Nordisk Investigational Site | Rockville | Maryland | 20852 | United States |
| Novo Nordisk Investigational Site | Waltham | Massachusetts | 02453 | United States |
| Novo Nordisk Investigational Site | Buckley | Michigan | 49620 | United States |
| Novo Nordisk Investigational Site | Chesterfield | Missouri | 63017 | United States |
| Novo Nordisk Investigational Site | Jefferson City | Missouri | 65109 | United States |
| Novo Nordisk Investigational Site | St Louis | Missouri | 63141 | United States |
| Novo Nordisk Investigational Site | Butte | Montana | 59701 | United States |
| Novo Nordisk Investigational Site | Clilfton | New Jersey | 07011 | United States |
| Novo Nordisk Investigational Site | Northport | New York | 11768 | United States |
| Novo Nordisk Investigational Site | Staten Island | New York | 10301 | United States |
| Novo Nordisk Investigational Site | Syracuse | New York | 13210 | United States |
| Novo Nordisk Investigational Site | Charlotte | North Carolina | 28277 | United States |
| Novo Nordisk Investigational Site | Greensboro | North Carolina | 27408 | United States |
| Novo Nordisk Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Novo Nordisk Investigational Site | Cayahoga Falls | Ohio | 44223 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45406 | United States |
| Novo Nordisk Investigational Site | Gallipolis | Ohio | 45631-1560 | United States |
| Novo Nordisk Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Novo Nordisk Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Novo Nordisk Investigational Site | Clarion | Pennsylvania | 16214 | United States |
| Novo Nordisk Investigational Site | Lancaster | Pennsylvania | 17601 | United States |
| Novo Nordisk Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Novo Nordisk Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novo Nordisk Investigational Site | Greer | South Carolina | 29651 | United States |
| Novo Nordisk Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| Novo Nordisk Investigational Site | Taylors | South Carolina | 29687 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37411 | United States |
| Novo Nordisk Investigational Site | Corpus Christi | Texas | 78404 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75230 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | United States |
| Novo Nordisk Investigational Site | Houston | Texas | 77025 | United States |
| Novo Nordisk Investigational Site | Hurst | Texas | 76054 | United States |
| Novo Nordisk Investigational Site | Odessa | Texas | 79761 | United States |
| Novo Nordisk Investigational Site | San Antonio | Texas | 78209 | United States |
| Novo Nordisk Investigational Site | St. George | Utah | 84790 | United States |
| Novo Nordisk Investigational Site | Virginia Beach | Virginia | 23462 | United States |
| Novo Nordisk Investigational Site | Renton | Washington | 98057 | United States |
| Novo Nordisk Investigational Site | Martinsburg | West Virginia | 25401 | United States |
| Novo Nordisk Investigational Site | Milwaukee | Wisconsin | 53209 | United States |
| Novo Nordisk Investigational Site | Buenos Aires | B1704ETD | Argentina |
| Novo Nordisk Investigational Site | Capital Federal | 1405 | Argentina |
| Novo Nordisk Investigational Site | Capital Federal | 1429 | Argentina |
| Novo Nordisk Investigational Site | Mar del Plata | B7600FZN | Argentina |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560 017 | India |
| Novo Nordisk Investigational Site | Chennai | Tamil Nadu | 600028 | India |
| Novo Nordisk Investigational Site | Thriruvananthapuram | 695 032 | India |
| Novo Nordisk Investigational Site | Manati | 00674 | Puerto Rico |
| Novo Nordisk Investigational Site | Trujillo Alto | 00976 | Puerto Rico |
| Novo Nordisk Investigational Site | Seoul | 110-746 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 130-701 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 138-736 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 139-707 | South Korea |
| Novo Nordisk Investigational Site | Bangkok | 10110 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10330 | Thailand |
| Novo Nordisk Investigational Site | Bangkok | 10400 | Thailand |
| Novo Nordisk Investigational Site | Pathum Thani | 12120 | Thailand |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IDet | Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day |
| BG001 | IGlar | Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day |
| BG002 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| HbA1c (Glycosylated haemoglobin A1c) | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin |
| |||||||||||||||
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mmol/L |
| |||||||||||||||
| Region of Enrolment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | meters |
| |||||||||||||||
| Stratification | Number | participants |
| ||||||||||||||||
| Diabetes History | Mean | Standard Deviation | years |
|
| 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 HbA1c From Baseline | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Mean | Standard Deviation | percentage point change | Week 0, Week 26 |
|
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Number | percentage of subjects | Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Number | percentage (%) of subjects | Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Number | percentage (%) of subjects | Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Number | percentage (%) of subjects | Week 26 |
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| Secondary | Fasting Plasma Glucose (FPG) | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Median | Standard Deviation | mmol/L | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. | Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment. | Posted | Mean | Standard Deviation | mmol/L | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Hypoglycaemic Episodes During the Trial | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | Weeks 0-26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycaemic Episodes, Diurnal | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | Weeks 0-26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycaemic Episodes, Nocturnal | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | Weeks 0-26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycemic Episodes, Unclassifiable | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. | Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | Weeks 0-26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight From Baseline | Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product. | Posted | Mean | Standard Deviation | kg | Week 0, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Having the Adverse Event "Incorrect Dose Administered" | Number of subjects having the adverse event "incorrect dose administered" within the system organ class "Injury, poisoning and procedural complications" | Safety Analysis Set: All subjects that received at least one dose of the trial product. | Posted | Number | Subjects | Weeks 0-26 |
|
|
Weeks 0-26
Safety Analysis Set: All subjects that received at least one dose of the trial product.
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 | IDet | Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day | 7 | 226 | 26 | 226 | ||
| EG001 | IGlar | Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day | 12 | 227 | 18 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Ludwig Angina | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Pneumonia | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Systematic Assessment |
| |
| Metastatic renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (unspecified) | Systematic Assessment |
| |
| Thoracic outlet syndrome | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (unspecified) | Systematic Assessment |
|
Novo Nordisk reserves the right not to release data before passing specified milestones. This includes the right not to release interim results that may later be found to be incorrect. At the end of the trial, one or more manuscripts will be prepared in collaboration between Investigator(s) and Novo Nordisk. Novo Nordisk will not suppress or veto publications but will reserve the right to postpone publication and/or communication for a short time to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D000069036 | Insulin Glargine |
| 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 |
|
| Asian |
|
| Black/African American |
|
| Native Hawaiian or pacific islander |
|
| White |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Applicable |
|
| India |
|
| Korea, Republic of |
|
| Thailand |
|
| United States |
|
| Metformin + other OAD other than TZD |
|
| Metformin monotherapy |
|
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