Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001050-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comb | Experimental | Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment |
|
| Sita | Active Comparator | Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin detemir | Drug | The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c (Glycosylated Haemoglobin A1c) | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Week 26 | |
| Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia | Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Vestavia Hills | Alabama | 35209 | United States | ||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21205123 | Result | Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) dose and dosing frequency. Subjects on sulphonylurea (SU) treatment randomised to the insulin detemir group had their SU discontinued
48 sites in 8 countries: Canada, Finland, France, Hungary, Slovakia, Republic of Korea, Turkey, and the United States of America (USA)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Comb | Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment |
| FG001 | Sita | Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| sitagliptin | Drug | The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily. |
|
| metformin | Drug | Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial. |
|
| sulphonylurea | Drug | Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator. |
|
| Week 26 |
| Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Week 26 |
| Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia | Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia | Week 26 |
| Change in BMI (Body Mass Index) | Week 0, Week 26 |
| Change in Body Weight | Week 0, Week 26 |
| FPG (Fasting Plasma Glucose) | Week 26 |
| Hypoglycemic Episodes | Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | Weeks 0-26 |
| Hypoglycemic Episodes: Day Time | Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | Weeks 0-26 |
| Hypoglycemic Episodes: Night Time | Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | Weeks 0-26 |
| Self-measured 9-point Plasma Glucose Profile | Week 26 |
| Orange |
| California |
| 92869 |
| United States |
| Novo Nordisk Investigational Site | Santa Monica | California | 90404 | United States |
| Novo Nordisk Investigational Site | Dunwoody | Georgia | 30338 | United States |
| Novo Nordisk Investigational Site | West Seneca | New York | 14224 | United States |
| Novo Nordisk Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Novo Nordisk Investigational Site | Dayton | Ohio | 45439 | United States |
| Novo Nordisk Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Novo Nordisk Investigational Site | Chattanooga | Tennessee | 37411 | United States |
| Novo Nordisk Investigational Site | Dallas | Texas | 75246 | United States |
| Novo Nordisk Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Novo Nordisk Investigational Site | New Westminster | British Columbia | V3L 3W5 | Canada |
| Novo Nordisk Investigational Site | St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Novo Nordisk Investigational Site | Cambridge | Ontario | N1R 7L6 | Canada |
| Novo Nordisk Investigational Site | Niagara Falls | Ontario | L2E 7H1 | Canada |
| Novo Nordisk Investigational Site | Toronto | Ontario | M3J 1N2 | Canada |
| Novo Nordisk Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| Novo Nordisk Investigational Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| Novo Nordisk Investigational Site | Sherbrooke | Quebec | J1H 4J6 | Canada |
| Novo Nordisk Investigational Site | Niagara Falls | L2G 5X7 | Canada |
| Novo Nordisk Investigational Site | Helsinki | FI-00350 | Finland |
| Novo Nordisk Investigational Site | Loimaa | FI-32200 | Finland |
| Novo Nordisk Investigational Site | Oulu | FI-90220 | Finland |
| Novo Nordisk Investigational Site | Pieksämäki | 76100 | Finland |
| Novo Nordisk Investigational Site | Pori | FI-28100 | Finland |
| Novo Nordisk Investigational Site | Seinäjoki | FI-60100 | Finland |
| Novo Nordisk Investigational Site | Brest | 29200 | France |
| Novo Nordisk Investigational Site | La Roche-sur-Yon | 85295 | France |
| Novo Nordisk Investigational Site | Le Creusot | 71200 | France |
| Novo Nordisk Investigational Site | Lille | 59037 | France |
| Novo Nordisk Investigational Site | Montigny-lès-Metz | 57950 | France |
| Novo Nordisk Investigational Site | Narbonne | 11108 | France |
| Novo Nordisk Investigational Site | Roubaix | 59100 | France |
| Novo Nordisk Investigational Site | Budapest | 1083 | Hungary |
| Novo Nordisk Investigational Site | Budapest | 1125 | Hungary |
| Novo Nordisk Investigational Site | Budapest | H-1212 | Hungary |
| Novo Nordisk Investigational Site | Eger | 3300 | Hungary |
| Novo Nordisk Investigational Site | Pécs | 7623 | Hungary |
| Novo Nordisk Investigational Site | Bratislava | 831 01 | Slovakia |
| Novo Nordisk Investigational Site | Bratislava | 851 01 | Slovakia |
| Novo Nordisk Investigational Site | Košice | 040 01 | Slovakia |
| Novo Nordisk Investigational Site | Lučenec | 98401 | Slovakia |
| Novo Nordisk Investigational Site | Prešov | 080 01 | Slovakia |
| Novo Nordisk Investigational Site | Žilina | 01001 | Slovakia |
| Novo Nordisk Investigational Site | Daegu | 705-717 | South Korea |
| Novo Nordisk Investigational Site | Incheon | 400-103 | South Korea |
| Novo Nordisk Investigational Site | Seoul | 135-239 | South Korea |
| Novo Nordisk Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34098 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Istanbul | 34390 | Turkey (Türkiye) |
| Novo Nordisk Investigational Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Exposed |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Comb | Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment |
| BG001 | Sita | Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| HbA1c | HbA1c = glycosylated haemoglobin A1c | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin |
| ||||||||||||||
| Height | Mean | Standard Deviation | meters |
| |||||||||||||||
| Body Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| BMI | BMI = Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Stratification | Previous OAD treatment | Number | participants |
| |||||||||||||||
| FPG | FPG = Fasting Plasma Glucose | Mean | Standard Deviation | mmol/L |
| ||||||||||||||
| Diabetes History | No. of years subject has been diagnosed with diabetes | 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 | HbA1c (Glycosylated Haemoglobin A1c) | Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Mean | Standard Error | Percent (%) glycosylated haemoglobin | Week 26 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Number | Subjects | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia | Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Number | Subjects | Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Number | Subjects | Week 26 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia | Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Number | Subjects | Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in BMI (Body Mass Index) | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Mean | Standard Error | kg/m^2 | Week 0, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Body Weight | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Mean | Standard Error | kg | Week 0, Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FPG (Fasting Plasma Glucose) | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Mean | Standard Error | mmol/L | Week 26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hypoglycemic Episodes | Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | SAS (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: Day Time | Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | SAS (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: Night Time | Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L | SAS (safety analysis set) is all randomised subjects exposed to at least one dose of trial product. | Posted | Number | episodes | Weeks 0-26 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Self-measured 9-point Plasma Glucose Profile | FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation. | Posted | Mean | Standard Error | mmol/L | Week 26 |
|
|
Weeks 0-26
Safety Analysis Set is all participants treated with 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 | Comb | Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment | 2 | 107 | 76 | 107 | ||
| EG001 | Sita | Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment | 4 | 110 | 72 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Optic ischaemic neuropathy | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Fibromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Influenza | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bronchitis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | 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 |
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| 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 |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Previous Metformin Monotherapy |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|