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This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.
Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
| |
| Type 2 diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. | Months 0-12 |
Not provided
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Inclusion Criteria:
Exclusion Criteria:
Not provided
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Patients from both general and speciality practice settings who have been deemed appropriate to receive Levemir® (insulin detemir) as new treatment and as part of routine out-patient care by the prescribing physician.
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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 | Brussels | 1070 | Belgium | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18096110 | Result | Dornhorst A, Luddeke HJ, Honka M, Ackermann RW, Merilainen M, Gallwitz B, Sreenan S; PREDICTIVE Study Group. Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study. Curr Med Res Opin. 2008 Feb;24(2):369-76. doi: 10.1185/030079908x260835. | |
| 18630615 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Subjects with type 1 or type 2 diabetes including newly diagnosed subjects who had never received insulin or an insulin analogue at the prescribing physician's discretion.
Study conducted globally in 26 countries. Some countries participated for only 3 months, while others extended their participation to 6 and 12 months, respectively.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Type 1 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
| FG001 | Type 2 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Type 1 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
| BG001 | Type 2 Diabetes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age: 3 months' participation |
| 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 | Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events | The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians. | FAS (Full Analysis Set) consists of all patients with a baseline visit who were prescribed insulin detemir at least once | Posted | Number | participants | Months 0-12 |
|
Over 3, 6 and 12 months, respectively, depending on the participating country
Full Analysis Set. This is a non-interventional study. According to the primary endpoint/outcome measure, the serious events collected in all countries are Serious Drug Reactions only, and not Serious Adverse Events and other adverse events
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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 | Type 1 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular extrasystoles | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Prague |
| 16000 |
| Czechia |
| Novo Nordisk Investigational Site | Copenhagen S | 2300 | Denmark |
| Novo Nordisk Investigational Site | Espoo | FI-02600 | Finland |
| Novo Nordisk Investigational Site | Paris La Défense Cedex | 92932 | France |
| Novo Nordisk Investigational Site | Vouliagment | 16671 | Greece |
| Novo Nordisk Investigational Site | Dublin | Ireland |
| Novo Nordisk Investigational Site | Kfar Saba | 44425 | Israel |
| Novo Nordisk Investigational Site | Rome | 00144 | Italy |
| Novo Nordisk Investigational Site | Seoul | 137-920 | South Korea |
| Novo Nordisk Investigational Site | Malmö | 202 15 | Sweden |
| Novo Nordisk Investigational Site | Istanbul | 34335 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Crawley | RH11 9RT | United Kingdom |
| Honka M. [Results of the PREDICTIVE project in the Czech Republic]. Vnitr Lek. 2008 Apr;54(4):361-7. Czech. |
| 18034846 | Result | Dornhorst A, Luddeke HJ, Koenen C, Merilainen M, King A, Robinson A, Sreenan S; PREDICTIVE Study Group. Transferring to insulin detemir from NPH insulin or insulin glargine in type 2 diabetes patients on basal-only therapy with oral antidiabetic drugs improves glycaemic control and reduces weight gain and risk of hypoglycaemia: 14-week follow-up data from PREDICTIVE. Diabetes Obes Metab. 2008 Jan;10(1):75-81. doi: 10.1111/j.1463-1326.2007.00816.x. Epub 2007 Nov 22. |
| 17313628 | Result | Dornhorst A, Luddeke HJ, Sreenan S, Koenen C, Hansen JB, Tsur A, Landstedt-Hallin L. Safety and efficacy of insulin detemir in clinical practice: 14-week follow-up data from type 1 and type 2 diabetes patients in the PREDICTIVE European cohort. Int J Clin Pract. 2007 Mar;61(3):523-8. doi: 10.1111/j.1742-1241.2007.01316.x. |
| 18324957 | Result | Dornhorst A, Luddeke HJ, Sreenan S, Kozlovski P, Hansen JB, Looij BJ, Meneghini L; PREDICTIVE Study Group. Insulin detemir improves glycaemic control without weight gain in insulin-naive patients with type 2 diabetes: subgroup analysis from the PREDICTIVE study. Int J Clin Pract. 2008 Apr;62(4):659-65. doi: 10.1111/j.1742-1241.2008.01715.x. |
| 17391171 | Result | Luddeke HJ, Sreenan S, Aczel S, Maxeiner S, Yenigun M, Kozlovski P, Gydesen H, Dornhorst A; PREDICTIVE Study Group. PREDICTIVE- a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab. 2007 May;9(3):428-34. doi: 10.1111/j.1463-1326.2006.00677.x. |
| 19166444 | Result | Sreenan S, Virkamaki A, Zhang K, Hansen JB; PREDICTIVE study group. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE study. Int J Clin Pract. 2008 Dec;62(12):1971-80. doi: 10.1111/j.1742-1241.2008.01939.x. |
| 18400145 | Result | Palmer JL, Goodall G, Nielsen S, Kotchie RW, Valentine WJ, Palmer AJ, Roze S. Cost-effectiveness of insulin aspart versus human soluble insulin in type 2 diabetes in four European countries: subgroup analyses from the PREDICTIVE study. Curr Med Res Opin. 2008 May;24(5):1417-28. doi: 10.1185/030079908x297295. Epub 2008 Apr 8. |
| 18568451 | Result | Valentine WJ, Goodall G, Aagren M, Nielsen S, Palmer AJ, Erny-Albrecht K. Evaluating the cost-effectiveness of therapy conversion to insulin detemir in patients with type 2 diabetes in Germany: a modelling study of long-term clinical and cost outcomes. Adv Ther. 2008 Jun;25(6):567-84. doi: 10.1007/s12325-008-0069-z. |
| 17823693 | Result | Hermansen K, Lund P, Clemmensen K, Breum L, Kleis Moller M, Mette Rosenfalck A, Christiansen E; Danish PREDICTIVE study group. 3-Month Results from Denmark within the Globally Prospective and Observational Study to Evaluate Insulin Detemir Treatment in Type 1 and Type 2 Diabetes: The PREDICTIVE Study. Rev Diabet Stud. 2007 Summer;4(2):89-97. doi: 10.1900/RDS.2007.4.89. Epub 2007 Aug 10. |
| 19513632 | Result | Fontaine P, Gin H, Pinget M, Thivolet C, Hanaire H, Robert JJ, Marre M, Venkatanarasimhachar S. Effect of insulin detemir dose frequency on clinical outcomes in patients with diabetes in PREDICTIVE. Adv Ther. 2009 May;26(5):535-51. doi: 10.1007/s12325-009-0033-6. Epub 2009 Jun 2. |
| 19739940 | Result | Hermansen K, Dornhorst A, Sreenan S. Observational, open-label study of type 1 and type 2 diabetes patients switching from human insulin to insulin analogue basal-bolus regimens: insights from the PREDICTIVE study. Curr Med Res Opin. 2009 Nov;25(11):2601-8. doi: 10.1185/03007990903262885. |
| 19747748 | Result | Niskanen L, Virkamaki A, Hansen JB, Saukkonen T. Fasting plasma glucose variability as a marker of nocturnal hypoglycemia in diabetes: evidence from the PREDICTIVE study. Diabetes Res Clin Pract. 2009 Nov;86(2):e15-8. doi: 10.1016/j.diabres.2009.08.005. Epub 2009 Sep 10. |
| 19222627 | Result | Yenigun M, Honka M. Switching patients from insulin glargine-based basal-bolus regimens to a once daily insulin detemir-based basal-bolus regimen: results from a subgroup of the PREDICTIVE study. Int J Clin Pract. 2009 Mar;63(3):425-32. doi: 10.1111/j.1742-1241.2008.01973.x. |
| 21988213 | Result | Perriello G, Caputo S, De Pergola G, Di Carlo A, Grassi G, Lapolla A, Pata P, Solerte SB, Zaccardi F. Improved glycemic control with weight loss and a low risk of hypoglycemia with insulin detemir: insights from the Italian cohort of the PREDICTIVE study after 6-month observation in type 2 diabetic subjects. Expert Opin Pharmacother. 2011 Nov;12(16):2449-55. doi: 10.1517/14656566.2011.626766. |
| 22265068 | Result | Yang L, Christensen T, Sun F, Chang J. Cost-effectiveness of switching patients with type 2 diabetes from insulin glargine to insulin detemir in Chinese setting: a health economic model based on the PREDICTIVE study. Value Health. 2012 Jan-Feb;15(1 Suppl):S56-9. doi: 10.1016/j.jval.2011.11.018. |
| 25023521 | Result | Sreenan S, Andersen M, Thorsted BL, Wolden ML, Evans M. Increased Risk of Severe Hypoglycemic Events with Increasing Frequency of Non-severe Hypoglycemic Events in Patients with Type 1 and Type 2 Diabetes. Diabetes Ther. 2014 Dec;5(2):447-58. doi: 10.1007/s13300-014-0075-x. Epub 2014 Jul 15. |
Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Age: 6 months' participation | Mean | Standard Deviation | years |
|
| Age, Continuous | Age: 12 months' participation | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Number | participants |
|
| Duration of diabetes (3 months' participation) | Mean | Standard Deviation | years |
|
| Duration of diabetes (6 months' participation) | Mean | Standard Deviation | years |
|
| Duration of diabetes (12 months' participation) | Mean | Standard Deviation | years |
|
| OG001 | Type 2 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. |
|
|
| 130 |
| 13,529 |
| 0 |
| 13,529 |
| EG001 | Type 2 Diabetes | Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment. | 80 | 37,641 | 0 | 37,641 |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypothermia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site stinging | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Blister | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Limp injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood glucose increase | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood glucose fluctuation | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood glucose decrease | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoglycaemia unawareness | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoglycaemic seizure | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Coma acidotic | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoglycaemic coma | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypoglycaemic encephalopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pityriasis rubra pilaris | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Transmyocardial revascularisation | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Hyperaemia | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Novo Nordisk acknowledges the physician's right to publish the entire results of the trial. Any such scientific paper, presentation, communication, or other information concerning the investigation described in this protocol, must be submitted in writing to Novo Nordisk Trial Manager prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |