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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00624364
First received: February 15, 2008
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: biphasic insulin aspart
Drug: metformin
 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: Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 24 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma glucose profiles [ Designated as safety issue: No ]
  • Cardiovascular risk factors [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: May 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (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 maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months
  • Body mass index (BMI) below 40.0 kg/m2
  • HbA1c between 7.5-13.0%

Exclusion Criteria:

  • History of drug or alcohol dependence
  • Mental incapacity, unwillingness or language barriers precluding adequate
  • Subjects previously screened to participation or having already participated in this trial
  • Receipt of any investigational drug within the last month prior to this trial
  • Known or suspected allergy to trial products or related products
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624364

Locations
South Africa
Brits, North West, South Africa, 0250
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Timothy Kedijang, MBChB, MSc Novo Nordisk Pty. Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00624364     History of Changes
Other Study ID Numbers: BIASP-1579
Study First Received: February 15, 2008
Last Updated: June 18, 2012
Health Authority: South Africa: Medicines Control Council

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 June 18, 2013