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This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin detemir | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20 | week 0, week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline | week 0, week 12 |
| Change in Fasting Plasma Glucose (FPG) | Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20 |
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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 |
|---|---|---|---|---|---|---|
| Seoul | South Korea |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Between screening and treatment with study drug, subjects were assessed for eligibility. After start of treatment, all subjects were to have their dosage titrated individually based on SMPG (self-monitored plasma glucose) values during the 20-week titration and treatment period to reach and maintain pre-breakfast SMPG below 6.0 mmol/L (108 mg/dL).
A total of eight study sites in South Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Detemir | Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| week 0, week 12, week 20 |
| Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0% | week 12, week 20 |
| Occurence of Hypoglycaemic Episodes | Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment. | weeks 0-20 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Detemir | Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20 | The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product. | Posted | Mean | Standard Deviation | percentage change in HbA1c | week 0, week 20 |
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| Secondary | Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline | The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product. | Posted | Mean | Standard Deviation | percentage change in HbA1c | week 0, week 12 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20 | The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product. | Posted | Mean | Standard Deviation | mg/dL | week 0, week 12, week 20 |
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| Secondary | Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0% | The analysis was based on Full Analysis Set (FAS) without any imputations. The definition of FAS is: All enrolled subjects exposed to at least one dose of study product and have at least one HbA1c data after 3 months being exposed to the study product. | Posted | Number | percentage of participants | week 12, week 20 |
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| Secondary | Occurence of Hypoglycaemic Episodes | Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment. | For tabulating the occurence of hypoglycaemic episodes, the safety analysis set of all enrolled subjects exposed to at least one dose of study drug was used. For the adverse events, please refer to details in the adverse events section. | Posted | Number | episodes | weeks 0-20 |
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Adverse events were collected in a time span of 22 weeks.
Safety analysis set contains all enrolled subjects exposed to at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Detemir | Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose. | 5 | 87 | 15 | 87 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis acute | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Pneumonia mycoplasmal | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (12.0) | Systematic Assessment |
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| Intestinal polyp | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (12.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Systematic Assessment |
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Novo Nordisk acknowledges the Investigator'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, should 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.
| 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 |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| 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 |
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