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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01850615
First received: April 17, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

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 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 18 ] [ Designated as safety issue: No ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-18 ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: Weeks 0-18 ] [ Designated as safety issue: No ]

Enrollment: 286
Study Start Date: September 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: insulin aspart (FIAsp)
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.

  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 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)
  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: NCT01850615

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35211
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35216
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72205
United States, California
Novo Nordisk Clinical Trial Call Center
Santa Ana, California, United States, 92705
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80922
Novo Nordisk Clinical Trial Call Center
Colorado Springs, Colorado, United States, 80909
United States, Florida
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33765
Novo Nordisk Clinical Trial Call Center
Pembroke Pines, Florida, United States, 33028
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Council Bluffs, Iowa, United States, 51503
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
New Orleans, Louisiana, United States, 70121
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Rockville, Maryland, United States, 20852
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Kalamazoo, Michigan, United States, 49009
United States, Nevada
Novo Nordisk Clinical Trial Call Center
Las Vegas, Nevada, United States, 89101
United States, New York
Novo Nordisk Clinical Trial Call Center
Brooklyn, New York, United States, 11229
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheboro, North Carolina, United States, 27203
United States, Ohio
Novo Nordisk Clinical Trial Call Center
Cincinnati, Ohio, United States, 45242
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Downingtown, Pennsylvania, United States, 19335-2620
Novo Nordisk Clinical Trial Call Center
Reading, Pennsylvania, United States, 19606
United States, South Carolina
Novo Nordisk Clinical Trial Call Center
Greenville, South Carolina, United States, 29605-4254
Novo Nordisk Clinical Trial Call Center
Greer, South Carolina, United States, 29651
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Clinical Trial Call Center
Fort Worth, Texas, United States, 76104
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77025-1669
Novo Nordisk Clinical Trial Call Center
San Antonio, Texas, United States, 78229
Novo Nordisk Clinical Trial Call Center
Sugarland, Texas, United States, 77478
United States, Utah
Novo Nordisk Clinical Trial Call Center
Ogden, Utah, United States, 84405
Argentina
Godoy Cruz, Argentina, M5501ARP
India
Hyderabad, Andhra Pradesh, India, 500034
Mexico
Mexico City, México, D.F., Mexico, 03300
Romania
Targu Mures, Mures, Romania, 540142
Slovenia
Novo mesto, Slovenia, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01850615     History of Changes
Other Study ID Numbers: NN1218-4049, 2012-005583-10, U1111-1137-6242, CTRI/2014/01/004289
Study First Received: April 17, 2013
Last Updated: April 8, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
India: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Romania: National Agency for Medicines and Medical Devices
Slovenia: Agency for Medicinal Products - Ministry of Health
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
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014