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.
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart (Drug); insulin glargine (Drug); metformin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Sebnem A. Tuna, MD, Study Director, Affiliation: Novo Nordisk Saglik Ürünleri Tic. Ltd. Sti.
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.
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: HbA1c
Secondary outcome: safety variablesother glycemic variables Fasting plasma glucose value
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Istanbul, Turkey
Additional Information
Clinical Trials at Novo Nordisk
Starting date: September 2004
Last updated: September 6, 2007
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