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Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
soluble human insulin
insulin aspart
insulin NPH
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 1 or 2 diabetes for at least 4 weeks
  • Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks
  • HbA1c: 7.5-13.5%
  • Body Mass Index (BMI): 18-35 kg/m2

Exclusion Criteria:

  • Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation
  • History of drug abuse or alcohol dependence

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

2-hours postprandial plasma glucose (PPPG)

Secondary Outcome Measures

Percentage of subjects achieving 2-hours PPPG treatment target
Percentage of subjects achieving HbA1c treatment target
HbA1c
Fasting plasma glucose
Hypoglycaemic episodes

Full Information

First Posted
January 2, 2008
Last Updated
December 21, 2016
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00593255
Brief Title
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
Official Title
A Multi-centre, Randomised, Parallel, Open Labelled Study to Compare the Efficiency and Safety Profile of Insulin Aspart (NovoRapid®) and Human Soluble Insulin (Novolin® R) as Meal Related Insulin in a Three Times Daily Regimen With One Injection of Novolin® N at Bedtime in Chinese Type 1 and 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Asia. The aim of this trial is to compare the efficacy of postprandial plasma glucose of two treatment regimens in Chinese subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
soluble human insulin
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Primary Outcome Measure Information:
Title
2-hours postprandial plasma glucose (PPPG)
Time Frame
after 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Percentage of subjects achieving 2-hours PPPG treatment target
Title
Percentage of subjects achieving HbA1c treatment target
Title
HbA1c
Title
Fasting plasma glucose
Title
Hypoglycaemic episodes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 or 2 diabetes for at least 4 weeks Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks HbA1c: 7.5-13.5% Body Mass Index (BMI): 18-35 kg/m2 Exclusion Criteria: Treatment with either soluble human insulin or insulin NPH three times daily within 3 months before trial participation History of drug abuse or alcohol dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100101
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Citations:
Citation
Gao Y, Pan C, Zou D, Xu Z, Liu X, Guo X. Superior prandial glucose control with Insulin Aspart compared to Regular Human Insulin in Basal Bolus Therapy with NPH in Patients with Inadequately Controlled T1DM or T2DM. ADA 2006 2006; 55 (Suppl. 1): A464 (2005-PO)
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes

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