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Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes (onset® 3)

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ClinicalTrials.gov Identifier: NCT01850615
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Asia, Europe, South America, and the United States of America (USA).

The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: Faster-acting insulin aspart Drug: basal insulin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes
Actual Study Start Date : September 23, 2013
Primary Completion Date : November 17, 2014
Study Completion Date : November 17, 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: FIAsp and basal insulin + metformin
Subjects will receive FIAsp combined with their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.
Drug: Faster-acting insulin aspart
Administrated subcutaneously (s.c., under the skin) at each main meal.
Other Name: NN1218
Drug: basal insulin
Administrated subcutaneously (s.c., under the skin) once daily.
Active Comparator: Basal insulin + metformin
Subjects will continue their pre-trial basal insulin (insulin human, insulin detemir or insulin glargine) treatment in combination with their pre-trial metformin.
Drug: basal insulin
Administrated subcutaneously (s.c., under the skin) once daily.



Primary Outcome Measures :
  1. Change From Baseline in HbA1c [ Time Frame: Week 0, week 18 ]
    For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.


Secondary Outcome Measures :
  1. Self-measured Plasma Glucose (SMPG) 7-point Profile: Post Prandial Plasma Glucose (PPG), Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal) [ Time Frame: After 18 weeks of randomised treatment ]
    For this endpoint the "end of trial" data containing last available measurements are presented. PPG measurements were recorded by the subjects at 2 hours after each meal (breakfast, lunch and main evening meal) as part of three 7-point profiles (SMPG) prior to the visits. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements.

  2. Self-measured Plasma Glucose (SMPG) 7-point Profile: Prandial Plasma Glucose (PG) Increment, Overall 2-hour Mean (of Breakfast, Lunch, Main Evening Meal) [ Time Frame: After 18 weeks of randomised treatment ]
    For this endpoint the "end of trial" data containing last available measurements are presented. Prandial PG increment for each meal (breakfast, lunch, main evening meal) was derived from the 7-point profiles (SMPG) as the difference between the PPG value 2 hours after each meal and the PG value before each meal. Individual mean meal PPG (post-breakfast, post-lunch, post-main evening meal) was derived from the three measurements.

  3. Change From Baseline in Body Weight [ Time Frame: Week 0, week 18 ]
    For this endpoint, baseline (week 0) and week 18 data are presented, where week 18 data are the "end of trial" data containing last available measurements.

  4. Number of Treatment Emergent Hypoglycaemic Episodes [ Time Frame: Weeks 0-18 ]
    Plasma glucose (PG) was measured and recorded when a hypoglycaemic episode was suspected. All PG values ≤3.9 mmol/L (70 mg/dL) or >3.9 mmol/L (70 mg/dL) when they occurred in conjunction with hypoglycaemic symptoms were recorded by the subject. Numbers of treatment emergent hypoglycaemic episodes were recorded during 18 weeks of treatment.

  5. Number of Adverse Events [ Time Frame: Weeks 0-18 ]
    All adverse events (AEs) described here refer to treatment emergent adverse events (TEAE). A TEAE was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment, week 18.



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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 at least 6 months prior to the screening visit (Visit 1)
  • Current treatment with once daily insulin detemir, insulin glargine or human isophane insulin, NPH 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 Dipeptidyl peptidase-IV 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) 7.5-9.5% (58 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (Visit 1) or b) 7.5-9.0% (58 - 75 mmol/mol) (both inclusive) in the metformin + other oral antidiabetic drug (OAD) (sulphonylurea (SU), glinide, dipeptidyl peptidase-IV (DDP-IV) inhibitors, alpha-glucosidase inhibitors (AGI) combination group at the screening visit (Visit 1)
  • Body mass index (BMI) equal or less than 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 of consecutive treatment) and not within 3 months prior to the screening visit (Visit 1)
  • Use of Glucagon-like peptide-1 (GLP-1) agonists and/or Thiazolidinediones (TZD) within the last 3 months prior to screening (visit 1)
  • Recurrent severe hypoglycaemia (more than one 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850615


  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35211
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35216
United States, Arizona
Novo Nordisk Investigational Site
Peoria, Arizona, United States, 85381
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Novo Nordisk Investigational Site
Santa Ana, California, United States, 92705
Novo Nordisk Investigational Site
Tarzana, California, United States, 91356-3551
United States, Colorado
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80907
Novo Nordisk Investigational Site
Colorado Springs, Colorado, United States, 80922
United States, Florida
Novo Nordisk Investigational Site
Clearwater, Florida, United States, 33765
Novo Nordisk Investigational Site
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Novo Nordisk Investigational Site
Conyers, Georgia, United States, 30094-5965
United States, Louisiana
Novo Nordisk Investigational Site
New Orleans, Louisiana, United States, 70121
United States, Maryland
Novo Nordisk Investigational Site
Rockville, Maryland, United States, 20852
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02118
United States, Michigan
Novo Nordisk Investigational Site
Kalamazoo, Michigan, United States, 49009
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68144
United States, Nevada
Novo Nordisk Investigational Site
Henderson, Nevada, United States, 89052
Novo Nordisk Investigational Site
Las Vegas, Nevada, United States, 89120
United States, New York
Novo Nordisk Investigational Site
Brooklyn, New York, United States, 11229
United States, North Carolina
Novo Nordisk Investigational Site
Asheboro, North Carolina, United States, 27203
United States, Ohio
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Downingtown, Pennsylvania, United States, 19335-2620
Novo Nordisk Investigational Site
Reading, Pennsylvania, United States, 19609
United States, South Carolina
Novo Nordisk Investigational Site
Greenville, South Carolina, United States, 29605-4254
Novo Nordisk Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119-3821
United States, Texas
Novo Nordisk Investigational Site
Fort Worth, Texas, United States, 76132
Novo Nordisk Investigational Site
Houston, Texas, United States, 77025-1669
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
United States, Utah
Novo Nordisk Investigational Site
Ogden, Utah, United States, 84405
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1250AAN
Novo Nordisk Investigational Site
Capital Federal, Argentina, C1056ABJ
Novo Nordisk Investigational Site
Córdoba, Argentina, X5006IKK
Novo Nordisk Investigational Site
Godoy Cruz, Argentina, M5501ARP
Novo Nordisk Investigational Site
San Isidro, Argentina, B1642DCD
India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500034
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India, 500082
Novo Nordisk Investigational Site
Visakhapatnam, Andhra Pradesh, India, 530002
Novo Nordisk Investigational Site
Bangalore, Karnataka, India, 560 017
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400007
Novo Nordisk Investigational Site
Mumbai, Maharashtra, India, 400058
Novo Nordisk Investigational Site
New Dehli, New Delhi, India, 110029
Novo Nordisk Investigational Site
Chandigarh, Punjab, India, 160012
Novo Nordisk Investigational Site
Coimbatore, Tamil Nadu, India, 641018
Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44150
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44650
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico, 03300
Romania
Novo Nordisk Investigational Site
Targu Mures, Mures, Romania, 540142
Novo Nordisk Investigational Site
Ploiesti, Prahova, Romania, 100097
Novo Nordisk Investigational Site
Timisoara, Timis, Romania, 300125
Novo Nordisk Investigational Site
Brasov, Romania, 500269
Novo Nordisk Investigational Site
Suceava, Romania, 720237
Slovenia
Novo Nordisk Investigational Site
Brezice, Slovenia, 8250
Novo Nordisk Investigational Site
Koper, Slovenia, SI-6000
Novo Nordisk Investigational Site
Kranj, Slovenia, 4000
Novo Nordisk Investigational Site
Novo mesto, Slovenia, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01850615     History of Changes
Other Study ID Numbers: NN1218-4049
2012-005583-10 ( EudraCT Number )
U1111-1137-6242 ( Other Identifier: WHO )
CTRI/2014/01/004289 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Posted: May 9, 2013    Key Record Dates
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Metformin
Insulin Glargine
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs