Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01618214
First received: June 11, 2012
Last updated: April 7, 2014
Last verified: April 2014

June 11, 2012
April 7, 2014
June 2012
January 2013   (final data collection date for primary outcome measure)
Change From Baseline in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Change from baseline in HbA1c (glycosylated haemoglobin) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01618214 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects Achieving HbA1c Below 7.0% [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Change From Baseline in FPG (Fasting Plasma Glucose) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only) [ Time Frame: Week 0 to week 20 (inclusive). ] [ Designated as safety issue: No ]
    Definition of a treatment emergent hypoglycemic episode: an episode occurred after the first administration of insulin or oral anti-diabetic drug, and no later than the last day on trial product. Severe hypoglycemic episode was that requiring assistance to administer carbohydrate, glucagon, or other resusciative actions. Minor hypoglycemic episode was the one with plasma glucose value < 3.1 mmol/L, either with symptoms that could be handled by subject, or without symptoms.
  • Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving HbA1c below or equal to 6.5% [ Time Frame: After 20 weeks of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in FPG (Fasting Blood Glucose) [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) [ Time Frame: Week 0 to week 20 (inclusive). ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes
A 20-week, Randomised, Open-label, 2-armed, Parallel Group Comparison of Subject-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Twice Daily Versus Investigator-driven Titration of BIAsp 30 Twice Daily Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes Inadequately Controlled With Premixed Human Insulin

This trial is conducted in Asia. The aim of this trial is to compare BIAsp 30 twice daily individually adjusted by the subject versus BIAsp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. Subjects to continue their OAD background treatment: Metformin plus/minus alpha-glucosidase inhibitor.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart 30
Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
  • Experimental: Subject-driven titration
    Intervention: Drug: biphasic insulin aspart 30
  • Active Comparator: Investigator-driven titration
    Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
344
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Type 2 diabetes mellitus (diagnosed clinically) for at least 12 months
  • Currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) BID (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (Visit 1) with the minimum dose stated: Metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to Visit 1) OR alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day
  • Total daily insulin dose below 1.4 IU/Kg
  • HbA1c above or equal to 7.0% and below or equal to 9.5% (central laboratory)
  • Body Mass Index (BMI) below or equal to 35.0 kg/m^2

Exclusion Criteria:

  • Treatment with any insulin secretagogue, thiazolidinedione (TZD), dipeptidyl peptidase-4 (DPP-4) inhibitors and Glucagon-like peptide-1 (GLP-1) receptor agonists within the last 3 months prior to Visit 1
  • Previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (CSII)) for more than 14 days
  • Previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) BID within 3 month prior to Visit 1
  • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
  • Known proliferative retinopathy or maculopathy requiring treatment
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01618214
BIASP-3984, U1111-1126-7610
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP