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

Novo Nordisk

Status and phase

Terminated

Phase 4

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: insulin NPH

Drug: insulin aspart

Drug: insulin detemir

Drug: metformin

Drug: human soluble insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01486966

NN304-3954

U1111-1123-7088 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.)