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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850615
First Posted: May 9, 2013
Last Update Posted: October 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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: Faster-acting insulin aspart Drug: basal insulin Phase 3

Study Type: Interventional
Study Design: 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

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 ]

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 ]
  • 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 ]
  • Change from baseline in body weight [ Time Frame: Week 0, week 18 ]
  • Number of treatment emergent hypoglycaemic episodes [ Time Frame: Weeks 0-18 ]
  • Number of adverse events [ Time Frame: Weeks 0-18 ]

Enrollment: 323
Actual Study Start Date: September 23, 2013
Study Completion Date: November 17, 2014
Primary Completion Date: November 17, 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: 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.

  Eligibility

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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)
  Contacts and Locations
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


  Show 58 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

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 Submitted: April 17, 2013
First Posted: May 9, 2013
Last Update Posted: October 31, 2017
Last Verified: March 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