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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00184626
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: biphasic insulin aspart Drug: insulin glargine Drug: metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : September 10, 2004
Actual Primary Completion Date : October 24, 2005
Actual Study Completion Date : October 24, 2005

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Primary Outcome Measures :
  1. HbA1c [ Time Frame: Measured at end of treatment (26 weeks) ]

Secondary Outcome Measures :
  1. safety variables
  2. other glycemic variables
  3. Fasting plasma glucose value


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184626


Locations
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Turkey
Novo Nordisk Investigational Site
Istanbul, Turkey, 111
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184626    
Other Study ID Numbers: BIASP-1594
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Insulin Aspart
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs