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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

NCT01486966 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-03-17

Study results available
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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.

Conditions

Interventions

DRUG

insulin detemir

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

DRUG

insulin aspart

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

DRUG

insulin NPH

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

DRUG

human soluble insulin

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

DRUG

metformin

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486966 on ClinicalTrials.gov