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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006589-41 | EudraCT Number |
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See termination reason in detailed description
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This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.
Novo Nordisk has decided to discontinue the trial as it will not be possible to recruit the required number of patients. The discontinuation is based on an analysis of the significant delay in recruitment of patients which is likely to have a negative impact on the validity of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin detemir | Experimental | Individually adjusted dose of insulin detemir once daily |
|
| Insulin NPH | Active Comparator | Individually adjusted dose of insulin NPH once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | Treat-to-target, s.c. (under the skin) injection, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) at Month 7 | week 0, month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) at Month 4 | week 0, month 4 | |
| Change in Mean Fasting Plasma Glucose (FPG) at Month 7 | week 0, month 7 | |
| Change in Mean Fasting Plasma Glucose (FPG) at Month 4 |
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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 |
|---|---|---|---|---|---|---|
| Paris La Défense | 92936 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33166419 | Derived | Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Subjects in the trial were patients with type 2 diabetes being treated with oral anti-diabetic drug (OAD) therapy(ies) for at least 3 months prior to the trial and considered to benefit from insulin treatment. The randomisation target for this trial was 286.
A total of 57 centres in 2 countries: France (35) and United Kingdom (22)
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Detemir | Individually adjusted dose of insulin detemir once daily |
| FG001 | Insulin NPH | Individually adjusted dose of insulin NPH once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Detemir | Individually adjusted dose of insulin detemir once daily |
| BG001 | Insulin NPH | Individually adjusted dose of insulin NPH once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Glycosylated Haemoglobin (HbA1c) at Month 7 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 7 |
|
|
The adverse events were collected from July 2007 to December 2008.
The safety analysis set is all patients who had been exposed to at least one dose of the trial products.
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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 | Individually adjusted dose of insulin detemir once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
Trial terminated prematurely due to low recruitment, and thus it was not possible to assess efficacy in this trial due to the small number of patients in each treatment group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
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| 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 |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin NPH |
| Drug |
Treat-to-target, s.c. (under the skin) injection, once daily |
|
| week 0, month 4 |
| Change in Mean Pre-lunch Plasma Glucose at Month 7 | week 0, month 7 |
| Change in Mean Pre-lunch Plasma Glucose at Month 4 | week 0, month 4 |
| Change in Mean Pre-dinner Plasma Glucose at Month 7 | week 0, month 7 |
| Change in Mean Pre-dinner Plasma Glucose at Month 4 | week 0, month 4 |
| Change in Body Weight at Month 7 | week 0, month 7 |
| Change in Body Weight at Month 4 | week 0, month 4 |
| Mean Number of Total Hypoglycaemic Episodes, Month 1 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | weeks -2-0, month 1 |
| Mean Number of Total Hypoglycaemic Episodes, Months 2-4 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | weeks -2-0, months 2-4 |
| Mean Number of Total Hypoglycaemic Episodes, Months 5-7 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | weeks -2-0, months 5-7 |
| Cambridge |
| CB2 2QQ |
| United Kingdom |
| Protocol Violation |
|
| Trial terminated |
|
| Not recorded |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Duration of diabetes | Number of years since diagnosis | Mean | Standard Deviation | years |
|
| Glycosylated Haemoglobin (HbA1c) | Mean | Standard Deviation | percentage of total haemoglobin |
|
| Weight | Mean | Standard Deviation | kg |
|
| Participants |
|
| Secondary | Change in Glycosylated Haemoglobin (HbA1c) at Month 4 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 4 |
|
|
| Secondary | Change in Mean Fasting Plasma Glucose (FPG) at Month 7 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 7 |
|
|
| Secondary | Change in Mean Fasting Plasma Glucose (FPG) at Month 4 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 4 |
|
|
| Secondary | Change in Mean Pre-lunch Plasma Glucose at Month 7 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 7 |
|
|
| Secondary | Change in Mean Pre-lunch Plasma Glucose at Month 4 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 4 |
|
|
| Secondary | Change in Mean Pre-dinner Plasma Glucose at Month 7 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 7 |
|
|
| Secondary | Change in Mean Pre-dinner Plasma Glucose at Month 4 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 4 |
|
|
| Secondary | Change in Body Weight at Month 7 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 7 |
|
|
| Secondary | Change in Body Weight at Month 4 | Due to the recruitment issue, the trial has been prematurely interrupted and the final number of patients does not allow any efficacy analysis. | Posted | week 0, month 4 |
|
|
| Secondary | Mean Number of Total Hypoglycaemic Episodes, Month 1 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints. | Posted | Mean | Standard Deviation | episodes per week by visit | weeks -2-0, month 1 |
|
|
|
| Secondary | Mean Number of Total Hypoglycaemic Episodes, Months 2-4 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints. | Posted | Mean | Standard Deviation | episodes per week by visit | weeks -2-0, months 2-4 |
|
|
|
| Secondary | Mean Number of Total Hypoglycaemic Episodes, Months 5-7 | Mean number of total hypoglycaemic episodes per patient expressed as rate per week by visit. Rate per week is calculated by dividing the number of episodes for each patient by the number of weeks in the period. | The safety analysis set is all patients who had been exposed to at least one dose of the trial product, and had hypoglycaemia data available at both endpoints. | Posted | Mean | Standard Deviation | episodes per week by visit | weeks -2-0, months 5-7 |
|
|
|
| 2 |
| 38 |
| 13 |
| 38 |
| EG001 | Insulin NPH | Individually adjusted dose of insulin NPH once daily | 8 | 48 | 11 | 48 |
| Bradycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Barrett's oesophagus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Campylobacter intestinal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Streptococcal sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
The Steering Committee has the 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 approved by the Steering Committee, and copies submitted in writing to Novo Nordisk prior to submission for publication/presentation for comments. Comments will be given within four weeks from receipt of the manuscript.
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Difference (month 1-screening) |
|
| Difference (months 2-4 - screening) |
|
| Difference (months 5-7 - screening) |
|