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
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: 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, Globin Zinc
Glargine
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Aspart
Biphasic Insulins
Insulin, Long-Acting
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014