Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin detemir; insulin aspart; insulin NPH; human soluble insulin; metformin
Intervention description: Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4; Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4; Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4; Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4; For subjects previously treated with metformin, the dosage and frequency will be kept unchanged
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Aspart; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of
      insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a
      basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes.

      The trial adopts a group sequential design, where the analysis of the primary efficacy
      endpoint will be performed at the interim analysis, in addition to the final formal analysis.
      The decision to continue or stop the trial will be based on the result of the interim
      analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer

          -  Currently treated with basal insulin once daily or premixed insulin twice daily for at
             least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU
             (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for
             at least 3 months)

          -  Body Mass Index (BMI) equal to 40 kg/m^2 or below

          -  HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory
             analysis

          -  Plan to be admitted for optimising glycaemic control at least 2 days prior to the
             randomisation

        Exclusion Criteria:

          -  Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor
             agonists within the last 3 months prior to the screening

          -  Anticipated change after the randomisation in concomitant medication known to
             interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and
             mono amine oxidase (MAO) inhibitors

          -  Previous participation in this trial (participation is defined as randomised.
             Re-screening of screening failures is allowed only once within the limits of the
             recruitment period.)