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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01819129
First received: March 21, 2013
Last updated: May 9, 2017
Last verified: May 2017
  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: Faster-acting insulin aspart
Drug: Insulin aspart
Drug: Insulin glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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 ]

Secondary Outcome Measures:
  • Change from baseline in 2-hour PPG increment (meal test) [ Time Frame: Week 0, week 26 ]
  • Number of treatment emergent confirmed hypoglycaemic episodes [ Time Frame: From week 0 to week 26 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 26 ]

Enrollment: 881
Actual Study Start Date: September 9, 2013
Study Completion Date: January 22, 2015
Primary Completion Date: January 22, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Faster-acting insulin aspart (FIAsp)
Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
Drug: Faster-acting insulin aspart
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
Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01819129

  Hide Study Locations
Locations
United States, Arizona
Novo Nordisk Investigational Site
Glendale, Arizona, United States, 85306-4652
Novo Nordisk Investigational Site
Glendale, Arizona, United States, 85308
Novo Nordisk Investigational Site
Mesa, Arizona, United States, 85213
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85020
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Tempe, Arizona, United States, 85283
United States, California
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Anaheim, California, United States, 92801
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Fresno, California, United States, 93720
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Greenbrae, California, United States, 94904
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Lomita, California, United States, 90717
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Northridge, California, United States, 91325
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San Diego, California, United States, 92111
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San Ramon, California, United States, 94583
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Walnut Creek, California, United States, 94598
United States, Colorado
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Aurora, Colorado, United States, 80045
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Colorado Springs, Colorado, United States, 80910
United States, Connecticut
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Waterbury, Connecticut, United States, 06708
United States, Florida
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Boynton Beach, Florida, United States, 33472
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Bradenton, Florida, United States, 34201
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Cooper City, Florida, United States, 33024
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Fort Lauderdale, Florida, United States, 33316
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Jacksonville, Florida, United States, 32205
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Jacksonville, Florida, United States, 32216
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Miami, Florida, United States, 33144
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Miami, Florida, United States, 33173
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Pembroke Pines, Florida, United States, 33027
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Plantation, Florida, United States, 33324
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Tampa, Florida, United States, 33603
United States, Georgia
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Atlanta, Georgia, United States, 30308-2253
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Atlanta, Georgia, United States, 30328
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Decatur, Georgia, United States, 30033
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Roswell, Georgia, United States, 30076
United States, Illinois
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Avon, Illinois, United States, 46123
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Peoria, Illinois, United States, 61602
United States, Indiana
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Indianapolis, Indiana, United States, 46254
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Muncie, Indiana, United States, 47304
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Louisville, Kentucky, United States, 40206
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Madisonville, Kentucky, United States, 42431-1661
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Monroe, Louisiana, United States, 71203
United States, Michigan
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Buckley, Michigan, United States, 49620
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Detroit, Michigan, United States, 48201
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Troy, Michigan, United States, 48085-5524
United States, Missouri
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Chesterfield, Missouri, United States, 63017
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Jefferson City, Missouri, United States, 65109
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Saint Louis, Missouri, United States, 63141
United States, Montana
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Butte, Montana, United States, 59701
United States, Nebraska
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Elkhorn, Nebraska, United States, 68022
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Omaha, Nebraska, United States, 68105
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Omaha, Nebraska, United States, 68198-3020
United States, New Jersey
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Toms River, New Jersey, United States, 08755-8050
United States, New York
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Mineola, New York, United States, 11501
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New Windsor, New York, United States, 12553
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North Massapequa, New York, United States, 11758-1802
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Northport, New York, United States, 11768
United States, North Carolina
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Hickory, North Carolina, United States, 28602
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Wilmington, North Carolina, United States, 28401
United States, Ohio
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Carlisle, Ohio, United States, 45005
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Cleveland, Ohio, United States, 44122
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Dayton, Ohio, United States, 45439
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Franklin, Ohio, United States, 45005
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Mason, Ohio, United States, 45040-6815
United States, Rhode Island
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East Providence, Rhode Island, United States, 02914
United States, South Carolina
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Gaffney, South Carolina, United States, 29341
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404-1192
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Kingsport, Tennessee, United States, 37660
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Spring Hill, Tennessee, United States, 37174
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Tullahoma, Tennessee, United States, 37388
United States, Texas
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75251
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Hurst, Texas, United States, 76054
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Plano, Texas, United States, 75075
United States, Utah
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Murray, Utah, United States, 84123
United States, Virginia
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Midlothian, Virginia, United States, 23114
United States, Washington
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Port Orchard, Washington, United States, 98366
United States, Wisconsin
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Kenosha, Wisconsin, United States, 53142
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Milwaukee, Wisconsin, United States, 53209
Canada, Alberta
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Edmonton, Alberta, Canada, T5J 3N4
Canada, British Columbia
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Surrey, British Columbia, Canada, V3S 2N6
Canada, Newfoundland and Labrador
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Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Ontario
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Hamilton, Ontario, Canada, L8M 1K7
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Thunder Bay, Ontario, Canada, P7B 7C7
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Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
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Mirabel, Quebec, Canada, J7J 2K8
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Montreal, Quebec, Canada, H1Y 3L1
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Montreal, Quebec, Canada, H2R 1V6
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St. Romuald, Quebec, Canada, G6W 5M6
Canada
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Quebec, Canada, G1G 3Y8
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Quebec, Canada, G1N 4V3
Croatia
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Cakovec, Croatia, 40000
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Karlovac, Croatia, 47000
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Osijek, Croatia, 31 000
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Slavonski Brod, Croatia, 35 000
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Split, Croatia, 21 000
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Varazdin, Croatia, 42 000
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Zagreb, Croatia, 10 000
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Zagreb, Croatia, 10000
India
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Hyderabad, Andhra Pradesh, India, 500082
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Indore, Madhya Pradesh, India, 452010
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Mumbai, Maharashtra, India, 400008
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Mumbai, Maharashtra, India, 400012
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Mumbai, Maharashtra, India, 400058
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Pune, Maharashtra, India, 411004
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Pune, Maharashtra, India, 411040
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Delhi, New Delhi, India, 110002
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Bhubaneswar, Orissa, India, 751019
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Jaipur, Rajasthan, India, 302006
Israel
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Beer Sheva, Israel, 84101
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Haifa, Israel, 35152
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Jerusalem, Israel, 91120
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Kfar Saba, Israel, 44281
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Rehovot, Israel, 76100
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Rishon Le Zion, Israel, 75650
Puerto Rico
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Ponce, Puerto Rico, 00717
Russian Federation
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 117036
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Moscow, Russian Federation, 119435
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Moscow, Russian Federation, 127644
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Penza, Russian Federation, 440026
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Saint-Petersburg, Russian Federation, 191119
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Saint-Petersburg, Russian Federation, 194291
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Saint-Petersburg, Russian Federation, 194358
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Saint-Petersburg, Russian Federation, 195257
Novo Nordisk Investigational Site
Saint-Petersburg, Russian Federation, 199034
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Saint-Petesburg, Russian Federation, 194156
Novo Nordisk Investigational Site
Stavropol, Russian Federation, 355017
Serbia
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Belgrade, Serbia, 11000
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Nis, Serbia, 18000
Novo Nordisk Investigational Site
Zajecar, Serbia, 19000
Slovakia
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Bratislava, Slovakia, 821 02
Novo Nordisk Investigational Site
Bratislava, Slovakia, 851 01
Novo Nordisk Investigational Site
Lucenec, Slovakia, 984 01
Novo Nordisk Investigational Site
Trnava, Slovakia, 91701
Novo Nordisk Investigational Site
Zilina, Slovakia, 01001
United Kingdom
Novo Nordisk Investigational Site
Epworth, United Kingdom, DN9 1EP
Novo Nordisk Investigational Site
Hull, United Kingdom, HU3 2RW
Novo Nordisk Investigational Site
Northampton, United Kingdom, NN1 5BD
Novo Nordisk Investigational Site
Northwood, United Kingdom, HA6 2RN
Novo Nordisk Investigational Site
Norwich, United Kingdom, NR4 7TJ
Novo Nordisk Investigational Site
Nuneaton, United Kingdom, CV10 7DJ
Novo Nordisk Investigational Site
Sidcup, United Kingdom, DA14 6LT
Novo Nordisk Investigational Site
Stoke on Trent, United Kingdom, ST4 6QG
Novo Nordisk Investigational Site
Wrexham, United Kingdom, LL13 7TD
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Faster Aspart Versus Insulin Aspart As Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode B. Diabetes Care 2017 May; DOI.org/10.2337/dc16-1770

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01819129     History of Changes
Other Study ID Numbers: NN1218-3853
2010-024051-93 ( EudraCT Number )
U1111-1118-2509 ( Other Identifier: WHO )
CTRI/2014/01/004285 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
Study First Received: March 21, 2013
Last Updated: May 9, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Metformin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2017