Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes (onset® 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01819129
First received: March 21, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin aspart (FIAsp)
Drug: insulin aspart
Drug: insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in 2-hour PPG increment (meal test) [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: From week 0 to week 26 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 676
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin aspart (FIAsp) Drug: insulin aspart (FIAsp)
Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Drug: insulin glargine
Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.
Active Comparator: Insulin aspart Drug: insulin aspart
Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Drug: insulin glargine
Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819129

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Glendale, Arizona, United States, 85308
Novo Nordisk Clinical Trial Call Center
Glendale, Arizona, United States, 85306-4652
Novo Nordisk Clinical Trial Call Center
Mesa, Arizona, United States, 85213
Novo Nordisk Clinical Trial Call Center
Phoenix, Arizona, United States, 85020
Novo Nordisk Clinical Trial Call Center
Tempe, Arizona, United States, 85283
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93720
Novo Nordisk Clinical Trial Call Center
Greenbrae, California, United States, 94904
Novo Nordisk Clinical Trial Call Center
Lomita, California, United States, 90717
Novo Nordisk Clinical Trial Call Center
Northridge, California, United States, 91325
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92111
Novo Nordisk Clinical Trial Call Center
San Ramon, California, United States, 94583
Novo Nordisk Clinical Trial Call Center
Walnut Creek, California, United States, 94598
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80045
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Novo Nordisk Clinical Trial Call Center
Waterbury, Connecticut, United States, 06708
United States, Florida
Novo Nordisk Clinical Trial Call Center
Boynton Beach, Florida, United States, 33472
Novo Nordisk Clinical Trial Call Center
Bradenton, Florida, United States, 34208
Novo Nordisk Clinical Trial Call Center
Cooper City, Florida, United States, 33024
Novo Nordisk Clinical Trial Call Center
Fort Lauderdale, Florida, United States, 33316-2521
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32205
Novo Nordisk Clinical Trial Call Center
Jacksonville, Florida, United States, 32216
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33173
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33144
Novo Nordisk Clinical Trial Call Center
Pembroke Pines, Florida, United States, 33027
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 33603
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Atlanta, Georgia, United States, 30308-2253
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Peoria, Illinois, United States, 61602
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Avon, Indiana, United States, 46123
Novo Nordisk Clinical Trial Call Center
Indianapolis, Indiana, United States, 46254
United States, Kansas
Novo Nordisk Clinical Trial Call Center
Topeka, Kansas, United States, 66606
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40206
Novo Nordisk Clinical Trial Call Center
Madisonville, Kentucky, United States, 42431-1661
Novo Nordisk Clinical Trial Call Center
Paducah, Kentucky, United States, 42003
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Buckley, Michigan, United States, 49620
Novo Nordisk Clinical Trial Call Center
Detroit, Michigan, United States, 48201
Novo Nordisk Clinical Trial Call Center
Troy, Michigan, United States, 48085-5524
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Chesterfield, Missouri, United States, 63017
Novo Nordisk Clinical Trial Call Center
Jefferson City, Missouri, United States, 65109-6001
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63141
United States, Montana
Novo Nordisk Clinical Trial Call Center
Butte, Montana, United States, 59701
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Elkhorn, Nebraska, United States, 68022
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Toms River, New Jersey, United States, 08755-8050
United States, New York
Novo Nordisk Clinical Trial Call Center
Mineola, New York, United States, 11501
Novo Nordisk Clinical Trial Call Center
New Windsor, New York, United States, 12553
Novo Nordisk Clinical Trial Call Center
North Massapequa, New York, United States, 11758-1802
Novo Nordisk Clinical Trial Call Center
Northport, New York, United States, 11768
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Hickory, North Carolina, United States, 28602
Novo Nordisk Clinical Trial Call Center
Wilmington, North Carolina, United States, 28401
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cleveland, Ohio, United States, 44122
Novo Nordisk Clinical Trial Call Center
Dayton, Ohio, United States, 45439
Novo Nordisk Clinical Trial Call Center
Franklin, Ohio, United States, 45005
Novo Nordisk Clinical Trial Call Center
Mason, Ohio, United States, 45040-6815
United States, Rhode Island
Novo Nordisk Clinical Trial Call Center
East Providence, Rhode Island, United States, 02914
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Gaffney, South Carolina, United States, 29341
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
Novo Nordisk Clinical Trial Call Center
Johnson City, Tennessee, United States, 37604
Novo Nordisk Clinical Trial Call Center
Spring Hill, Tennessee, United States, 37174
Novo Nordisk Clinical Trial Call Center
Tullahoma, Tennessee, United States, 37388
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75251
Novo Nordisk Clinical Trial Call Center
Hurst, Texas, United States, 76054
Novo Nordisk Clinical Trial Call Center
Plano, Texas, United States, 75075
United States, Utah
Novo Nordisk Clinical Trial Call Center
Murray, Utah, United States, 84123
United States, Virginia
Novo Nordisk Clinical Trial Call Center
Midlothian, Virginia, United States, 23114
United States, Washington
Novo Nordisk Clinical Trial Call Center
Port Orchard, Washington, United States, 98366
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Kenosha, Wisconsin, United States, 53142-7884
Novo Nordisk Clinical Trial Call Center
Milwaukee, Wisconsin, United States, 53209
Canada, British Columbia
Surrey, British Columbia, Canada, V3S 2N6
Croatia
Osijek, Croatia, 31 000
India
Indore, Madhya Pradesh, India, 452010
Israel
Beer Sheva, Israel, 84101
Puerto Rico
Novo Nordisk Clinical Trial Call Center
Ponce, Puerto Rico, 00717
Russian Federation
Saint-Petersburg, Russian Federation, 194358
Serbia
Belgrade, Serbia, 11000
Slovakia
Bratislava, Slovakia, 851 01
United Kingdom
Stoke on Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Kit Gjølbye Madsen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01819129     History of Changes
Other Study ID Numbers: NN1218-3853, U1111-1118-2509, CTRI/2014/01/004285
Study First Received: March 21, 2013
Last Updated: April 28, 2014
Health Authority: Canada: Health Canada
Croatia: Ministry of Health and Social Care
India: Drugs Controller General of India
Israel: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Serbia: Agency for Drugs and Medicinal Devices
Slovakia: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014