Diabetes Mellitus, Type 2 Clinical Trial
— Full STEP™Official title:
A Randomised, Controlled, Open Label, Multicentre, Multinational, Treat-to-target Trial Investigating the Efficacy and Safety of Intensification With Addition of Bolus Insulin Aspart in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin With or Without Oral Anti-diabetic Drugs: Step-wise Addition Versus Complete Basal-bolus Therapy
This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.
Status | Completed |
Enrollment | 401 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for at least 12 months - Basal insulin treatment (NPH once or twice daily, insulin glargine once daily or insulin detemir once daily) for at least 6 months - HbA1c: 7.0-9.0 % (both inclusive) by central laboratory analysis (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) - BMI (Body Mass Index) less than 40.0 kg/m^2 Exclusion Criteria: - Previous use of pre-mix or bolus insulin (allowed is previous use of bolus insulin only in case of a hospitalisation or a severe condition requiring intermittent use of bolus insulin for less than 14 consecutive days, but not during the last 6 months prior to screening visit (Visit 1) - Use of GLP-1 (Glucagon-like peptide-1) receptor agonists or pramlintide within the last 6 months prior to prior to screening visit (Visit 1) - Anticipated change in concomitant medication known to interfere significantly with glucose metabolism (e.g. systemic corticosteroids, beta-blockers, MAO (Monoamine oxidase) inhibitors, etc.) - Cardiovascular disease, within the last 12 months prior to screening visit (Visit 1), defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty - Uncontrolled treated/untreated severe hypertension (systolic blood pressure sitting at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg). For Argentina: systolic blood pressure sitting at least 150 mmHg and/or diastolic blood pressure at least 90 mmHg - Impaired liver function, defined as ALAT (Alanine aminotransferase) at least 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive) - Impaired renal function defined as serum creatinine above 135 micromol/L (above 1.5 mg/dL) for males and above 110 micromol/L (above 1.2 mg/dL) for females; and, if required by the locally applicable metformin label, glomerular filtration rate below 60 ml/min, calculated by the Cockroft & Gault formula). One retest within a week is permitted with the result of the last sample being conclusive - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months - Proliferative retinopathy or maculopathy requiring treatment according to the Investigator - Treatment with OADs (Oral anti-diabetic drug) contraindicated or unapproved for combination treatment with insulin (according to local OAD label) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Novo Nordisk Clinical Trial Call Center | Atlanta | Georgia |
United States | Novo Nordisk Clinical Trial Call Center | Beavercreek | Ohio |
United States | Novo Nordisk Clinical Trial Call Center | Birmingham | Alabama |
United States | Novo Nordisk Clinical Trial Call Center | Brooklyn Center | Minnesota |
United States | Novo Nordisk Clinical Trial Call Center | Chicago | Illinois |
United States | Novo Nordisk Clinical Trial Call Center | Dallas | Texas |
United States | Novo Nordisk Clinical Trial Call Center | Dayton | Ohio |
United States | Novo Nordisk Clinical Trial Call Center | Doral | Florida |
United States | Novo Nordisk Clinical Trial Call Center | Fresno | California |
United States | Novo Nordisk Clinical Trial Call Center | Greer | South Carolina |
United States | Novo Nordisk Clinical Trial Call Center | Hialeah | Florida |
United States | Novo Nordisk Clinical Trial Call Center | Indianapolis | Indiana |
United States | Novo Nordisk Clinical Trial Call Center | Jefferson City | Missouri |
United States | Novo Nordisk Clinical Trial Call Center | Kettering | Ohio |
United States | Novo Nordisk Clinical Trial Call Center | Kissimmee | Florida |
United States | Novo Nordisk Clinical Trial Call Center | Las Vegas | Nevada |
United States | Novo Nordisk Clinical Trial Call Center | Lawrenceville | New Jersey |
United States | Novo Nordisk Clinical Trial Call Center | Metairie | Louisiana |
United States | Novo Nordisk Clinical Trial Call Center | Miami | Florida |
United States | Novo Nordisk Clinical Trial Call Center | New Windsor | New York |
United States | Novo Nordisk Clinical Trial Call Center | Norfolk | Virginia |
United States | Novo Nordisk Clinical Trial Call Center | Philadelphia | Pennsylvania |
United States | Novo Nordisk Clinical Trial Call Center | Plantation | Florida |
United States | Novo Nordisk Clinical Trial Call Center | Port Charlotte | Florida |
United States | Novo Nordisk Clinical Trial Call Center | Rockville | Maryland |
United States | Novo Nordisk Clinical Trial Call Center | Roswell | Georgia |
United States | Novo Nordisk Clinical Trial Call Center | Salt Lake City | Utah |
United States | Novo Nordisk Clinical Trial Call Center | Salt Lake City | Utah |
United States | Novo Nordisk Clinical Trial Call Center | Scottsdale | Arizona |
United States | Novo Nordisk Clinical Trial Call Center | Springfield | Massachusetts |
United States | Novo Nordisk Clinical Trial Call Center | Tipton | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
United States, Argentina, Brazil, Canada, France, Macedonia, The Former Yugoslav Republic of, Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 32 | Estimated mean change from baseline in HbA1c after 32 Weeks of treatment | Week 0, Week 32 | No |
Secondary | Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 10 | Estimated mean change from baseline in HbA1c after 10 Weeks of treatment | Week 0, Week 10 | No |
Secondary | Change in Glycosylated Haemoglobin (HbA1c) From Baseline to Week 21 | Estimated mean change from baseline in HbA1c after 21 Weeks of treatment | Week 0, Week 21 | No |
Secondary | Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 10 | Proportion of subjects reaching HbA1c below 7.0% at Week 10 | Week 10 | No |
Secondary | Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 21 | Proportion of subjects reaching HbA1c below 7.0% at Week 21 | Week 21 | No |
Secondary | Proportion of Subjects Reaching Glycosylated Haemoglobin (HbA1c) Below 7.0% at Week 32 | Proportion of subjects reaching HbA1c below 7.0% at Week 32 | Week 32 | No |
Secondary | Fasting Plasma Glucose (FPG) at Week 10 | Mean FPG at Week 10 | Week 10 | No |
Secondary | Fasting Plasma Glucose (FPG) at Week 21 | Mean FPG at Week 21 | Week 21 | No |
Secondary | Fasting Plasma Glucose (FPG) at Week 32 | Estimated Mean FPG at Week 32 | Week 32 | No |
Secondary | Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 10 | Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 10 | Week 10 | No |
Secondary | Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 21 | Mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 21 | Week 21 | No |
Secondary | Mean Plasma Glucose Increment Over 3 Meals (Breakfast, Lunch and Dinner) at Week 32 | Estimated mean plasma glucose increment over 3 meals (breakfast, lunch and dinner) at Week 32 | Week 32 | No |
Secondary | Body Weight at Week 32 | Estimated mean body weight after 32 Weeks of treatment | Week 32 | No |
Secondary | Body Mass Index (BMI) at Week 32 | Estimated mean BMI after 32 Weeks of treatment | Week 32 | No |
Secondary | Hypoglycaemic Episodes (Rate of All Treatment Emergent Hypoglycaemia Episodes) | A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. | Week 0 to Week 32 | No |
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