Diabetes Mellitus, Type 2 Clinical Trial
— onset® 2Official title:
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
| Verified date | January 2019 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes.
| Status | Completed |
| Enrollment | 881 |
| Est. completion date | January 22, 2015 |
| Est. primary completion date | January 22, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Type 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - Treated with basal insulin for at least 6 months prior to screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI) equal to or below 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (visit 1) - Cardiovascular disease, within the last 6 months prior to screening (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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novo Nordisk Investigational Site | Edmonton | Alberta |
| Canada | Novo Nordisk Investigational Site | Hamilton | Ontario |
| Canada | Novo Nordisk Investigational Site | Mirabel | Quebec |
| Canada | Novo Nordisk Investigational Site | Montreal | Quebec |
| Canada | Novo Nordisk Investigational Site | Montreal | Quebec |
| Canada | Novo Nordisk Investigational Site | Mount Pearl | Newfoundland and Labrador |
| Canada | Novo Nordisk Investigational Site | Quebec | |
| Canada | Novo Nordisk Investigational Site | Quebec | |
| Canada | Novo Nordisk Investigational Site | St. John's | Newfoundland and Labrador |
| Canada | Novo Nordisk Investigational Site | St. Romuald | Quebec |
| Canada | Novo Nordisk Investigational Site | Surrey | British Columbia |
| Canada | Novo Nordisk Investigational Site | Thunder Bay | Ontario |
| Canada | Novo Nordisk Investigational Site | Waterloo | Ontario |
| Croatia | Novo Nordisk Investigational Site | Cakovec | |
| Croatia | Novo Nordisk Investigational Site | Karlovac | |
| Croatia | Novo Nordisk Investigational Site | Osijek | |
| Croatia | Novo Nordisk Investigational Site | Slavonski Brod | |
| Croatia | Novo Nordisk Investigational Site | Split | |
| Croatia | Novo Nordisk Investigational Site | Varazdin | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| Croatia | Novo Nordisk Investigational Site | Zagreb | |
| India | Novo Nordisk Investigational Site | Bhubaneswar | Orissa |
| India | Novo Nordisk Investigational Site | Delhi | New Delhi |
| India | Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh |
| India | Novo Nordisk Investigational Site | Indore | Madhya Pradesh |
| India | Novo Nordisk Investigational Site | Jaipur | Rajasthan |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Mumbai | Maharashtra |
| India | Novo Nordisk Investigational Site | Pune | Maharashtra |
| India | Novo Nordisk Investigational Site | Pune | Maharashtra |
| Israel | Novo Nordisk Investigational Site | Beer Sheva | |
| Israel | Novo Nordisk Investigational Site | Haifa | |
| Israel | Novo Nordisk Investigational Site | Jerusalem | |
| Israel | Novo Nordisk Investigational Site | Kfar Saba | |
| Israel | Novo Nordisk Investigational Site | Rehovot | |
| Israel | Novo Nordisk Investigational Site | Rishon Le Zion | |
| Puerto Rico | Novo Nordisk Investigational Site | Ponce | |
| Russian Federation | Novo Nordisk Investigational Site | Kursk | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Moscow | |
| Russian Federation | Novo Nordisk Investigational Site | Penza | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petersburg | |
| Russian Federation | Novo Nordisk Investigational Site | Saint-Petesburg | |
| Russian Federation | Novo Nordisk Investigational Site | Stavropol | |
| Serbia | Novo Nordisk Investigational Site | Belgrade | |
| Serbia | Novo Nordisk Investigational Site | Nis | |
| Serbia | Novo Nordisk Investigational Site | Zajecar | |
| Slovakia | Novo Nordisk Investigational Site | Bratislava | |
| Slovakia | Novo Nordisk Investigational Site | Bratislava | |
| Slovakia | Novo Nordisk Investigational Site | Lucenec | |
| Slovakia | Novo Nordisk Investigational Site | Trnava | |
| Slovakia | Novo Nordisk Investigational Site | Zilina | |
| United Kingdom | Novo Nordisk Investigational Site | Epworth | |
| United Kingdom | Novo Nordisk Investigational Site | Hull | |
| United Kingdom | Novo Nordisk Investigational Site | Northampton | |
| United Kingdom | Novo Nordisk Investigational Site | Northwood | |
| United Kingdom | Novo Nordisk Investigational Site | Norwich | |
| United Kingdom | Novo Nordisk Investigational Site | Nuneaton | |
| United Kingdom | Novo Nordisk Investigational Site | Sidcup | |
| United Kingdom | Novo Nordisk Investigational Site | Stoke on Trent | |
| United Kingdom | Novo Nordisk Investigational Site | Wrexham | |
| United States | Novo Nordisk Investigational Site | Anaheim | California |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Atlanta | Georgia |
| United States | Novo Nordisk Investigational Site | Aurora | Colorado |
| United States | Novo Nordisk Investigational Site | Avon | Illinois |
| United States | Novo Nordisk Investigational Site | Boynton Beach | Florida |
| United States | Novo Nordisk Investigational Site | Bradenton | Florida |
| United States | Novo Nordisk Investigational Site | Buckley | Michigan |
| United States | Novo Nordisk Investigational Site | Butte | Montana |
| United States | Novo Nordisk Investigational Site | Carlisle | Ohio |
| United States | Novo Nordisk Investigational Site | Chattanooga | Tennessee |
| United States | Novo Nordisk Investigational Site | Chesterfield | Missouri |
| United States | Novo Nordisk Investigational Site | Cleveland | Ohio |
| United States | Novo Nordisk Investigational Site | Colorado Springs | Colorado |
| United States | Novo Nordisk Investigational Site | Cooper City | Florida |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dallas | Texas |
| United States | Novo Nordisk Investigational Site | Dayton | Ohio |
| United States | Novo Nordisk Investigational Site | Decatur | Georgia |
| United States | Novo Nordisk Investigational Site | Detroit | Michigan |
| United States | Novo Nordisk Investigational Site | East Providence | Rhode Island |
| United States | Novo Nordisk Investigational Site | Elkhorn | Nebraska |
| United States | Novo Nordisk Investigational Site | Fort Lauderdale | Florida |
| United States | Novo Nordisk Investigational Site | Franklin | Ohio |
| United States | Novo Nordisk Investigational Site | Fresno | California |
| United States | Novo Nordisk Investigational Site | Gaffney | South Carolina |
| United States | Novo Nordisk Investigational Site | Glendale | Arizona |
| United States | Novo Nordisk Investigational Site | Glendale | Arizona |
| United States | Novo Nordisk Investigational Site | Greenbrae | California |
| United States | Novo Nordisk Investigational Site | Hickory | North Carolina |
| United States | Novo Nordisk Investigational Site | Hurst | Texas |
| United States | Novo Nordisk Investigational Site | Indianapolis | Indiana |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jacksonville | Florida |
| United States | Novo Nordisk Investigational Site | Jefferson City | Missouri |
| United States | Novo Nordisk Investigational Site | Kenosha | Wisconsin |
| United States | Novo Nordisk Investigational Site | Kingsport | Tennessee |
| United States | Novo Nordisk Investigational Site | Lomita | California |
| United States | Novo Nordisk Investigational Site | Louisville | Kentucky |
| United States | Novo Nordisk Investigational Site | Madisonville | Kentucky |
| United States | Novo Nordisk Investigational Site | Mason | Ohio |
| United States | Novo Nordisk Investigational Site | Mesa | Arizona |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Miami | Florida |
| United States | Novo Nordisk Investigational Site | Midlothian | Virginia |
| United States | Novo Nordisk Investigational Site | Milwaukee | Wisconsin |
| United States | Novo Nordisk Investigational Site | Mineola | New York |
| United States | Novo Nordisk Investigational Site | Monroe | Louisiana |
| United States | Novo Nordisk Investigational Site | Muncie | Indiana |
| United States | Novo Nordisk Investigational Site | Murray | Utah |
| United States | Novo Nordisk Investigational Site | New Windsor | New York |
| United States | Novo Nordisk Investigational Site | North Massapequa | New York |
| United States | Novo Nordisk Investigational Site | Northport | New York |
| United States | Novo Nordisk Investigational Site | Northridge | California |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Omaha | Nebraska |
| United States | Novo Nordisk Investigational Site | Paducah | Kentucky |
| United States | Novo Nordisk Investigational Site | Pembroke Pines | Florida |
| United States | Novo Nordisk Investigational Site | Peoria | Illinois |
| United States | Novo Nordisk Investigational Site | Phoenix | Arizona |
| United States | Novo Nordisk Investigational Site | Plano | Texas |
| United States | Novo Nordisk Investigational Site | Plantation | Florida |
| United States | Novo Nordisk Investigational Site | Port Orchard | Washington |
| United States | Novo Nordisk Investigational Site | Roswell | Georgia |
| United States | Novo Nordisk Investigational Site | Saint Louis | Missouri |
| United States | Novo Nordisk Investigational Site | San Diego | California |
| United States | Novo Nordisk Investigational Site | San Ramon | California |
| United States | Novo Nordisk Investigational Site | Spring Hill | Tennessee |
| United States | Novo Nordisk Investigational Site | Tampa | Florida |
| United States | Novo Nordisk Investigational Site | Tempe | Arizona |
| United States | Novo Nordisk Investigational Site | Toms River | New Jersey |
| United States | Novo Nordisk Investigational Site | Topeka | Kansas |
| United States | Novo Nordisk Investigational Site | Troy | Michigan |
| United States | Novo Nordisk Investigational Site | Tullahoma | Tennessee |
| United States | Novo Nordisk Investigational Site | Walnut Creek | California |
| United States | Novo Nordisk Investigational Site | Waterbury | Connecticut |
| United States | Novo Nordisk Investigational Site | Wilmington | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States, Canada, Croatia, India, Israel, Puerto Rico, Russian Federation, Serbia, Slovakia, United Kingdom,
Bode BW, Bowering K, Russell-Jones D. Response to Comment on Russell-Jones et al. Diabetes Care 2017;40:943-950. Comment on Bowering et al. Diabetes Care 2017;40:951-957. Diabetes Care. 2018 Mar;41(3):e29-e30. doi: 10.2337/dci17-0051. — View Citation
Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7): — View Citation
Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c | The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement. | Week 0, Week 26 | |
| Secondary | Change From Baseline in 2-hour PPG Increment (Meal Test) | For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement. | Week 0, week 26 | |
| Secondary | Number of Treatment Emergent Confirmed Hypoglycaemic 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 randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. | From Week 0 to Week 26. | |
| Secondary | Change From Baseline in Body Weight | For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement. | Week 0, week 26 |
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