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NCT00592969 Clinical Trial

Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart 30 in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00592969
Other study ID # BIASP-1570
Secondary ID
Status Completed
Phase Phase 4
First received January 2, 2008
Last updated February 22, 2017
Start date December 3, 2003
Est. completion date November 2, 2004

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date November 2, 2004
Est. primary completion date November 2, 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Currently treated with insulin NPH or are insulin-naive

- Body mass index (BMI) below 35.0 kg/m2

- HbA1c between 7.5-11.0%

Exclusion Criteria:

- Participation in any other clinical trial involving investigational products within the last 3 months

- History of drug or alcohol dependence

- Known impaired hepatic function

- Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• metformin

• biphasic insulin aspart

Locations
Country Name City State
Argentina Novo Nordisk Investigational Site Mariano Acosta s/n
Brazil Novo Nordisk Investigational Site Santa Efigenia

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 12 weeks of treatment
Secondary PPBG values
Secondary Glucose profiles
Secondary Hypoglycemia
Secondary Adverse events
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