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Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

NCT01123980 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2017-02-24

Study results available
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Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Conditions

Interventions

DRUG

biphasic insulin aspart 30

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

DRUG

metformin

China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day.

DRUG

glimepiride

China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day.

DRUG

insulin glargine

Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

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
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • China
  • Japan

Study Locations

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Entities

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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 NCT01123980 on ClinicalTrials.gov