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NCT Number: NCT01618214

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 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart 30

Drug

Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.

Primary outcomes

  1. Change From Baseline in HbA1c (Glycosylated Haemoglobin)

    Time frame: Week 0, week 20

    Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).

Secondary outcomes

  1. Percentage of Subjects Achieving HbA1c Below 7.0%

    Time frame: After 20 weeks of treatment

  2. Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

    Time frame: After 20 weeks of treatment

  3. Change From Baseline in FPG (Fasting Plasma Glucose)

    Time frame: Week 0, week 20

  4. Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)

    Time frame: Week 0 to week 20 (inclusive).

    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.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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