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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00592969
First received: January 2, 2008
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: metformin
Drug: biphasic insulin aspart
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PPBG values [ Designated as safety issue: No ]
  • Glucose profiles [ Designated as safety issue: No ]
  • Hypoglycemia [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: December 2003
Study Completion Date: November 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592969

Locations
Argentina
Mariano Acosta s/n, Argentina, 5016
Brazil
Santa Efigenia, Brazil, 30150-320
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Plamen Kozlovski Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00592969     History of Changes
Other Study ID Numbers: BIASP-1570
Study First Received: January 2, 2008
Last Updated: October 18, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin aspart
Insulin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014