Comparison of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin in Subjects With Type 2 Diabetes.

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184626
First received: September 12, 2005
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Insulin glargine versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in combination with metformin in subjects with Type 2 Diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: insulin glargine
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: Safety and Efficacy of Insulin Glargine Versus Biphasic Insulin Aspart 30/70 or Biphasic Insulin Aspart 30/70 in Combination With Metformin 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: Measured at end of treatment (26 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety variables [ Designated as safety issue: No ]
  • other glycemic variables [ Designated as safety issue: No ]
  • Fasting plasma glucose value [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: September 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Body mass index equal to or lesser than 35.0 kg/m2
  • Currently treated with oral hypoglycaemic drug

Exclusion Criteria:

  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
  • Any condition that the Investigator and/or the Sponsor feel would interfere with trial participation or evaluation of results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184626

Locations
Turkey
Istanbul, Turkey
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Sebnem A. Tuna, MD Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184626     History of Changes
Other Study ID Numbers: BIASP-1594
Study First Received: September 12, 2005
Last Updated: June 15, 2012
Health Authority: Turkey: Ministry of Health Drug and Pharmaceutical Department

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

ClinicalTrials.gov processed this record on April 15, 2014