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

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin detemir / IAsp

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4

insulin aspart

Intervention Type DRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4

metformin

Intervention Type DRUG

For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

insulin NPH

Group Type ACTIVE_COMPARATOR

insulin NPH

Intervention Type DRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4

human soluble insulin

Intervention Type DRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4

metformin

Intervention Type DRUG

For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

Interventions

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insulin detemir

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4

Intervention Type DRUG

insulin aspart

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4

Intervention Type DRUG

insulin NPH

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4

Intervention Type DRUG

human soluble insulin

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4

Intervention Type DRUG

metformin

For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

Intervention Type DRUG

Eligibility Criteria

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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.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No