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Clinical Trials/NCT00605020
NCT00605020
Completed
Phase 3

Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

Novo Nordisk A/S1 site in 1 country719 target enrollmentDecember 2, 2003
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ConditionsDiabetesDiabetes Mellitus, Type 2
Drugsinsulin detemirinsulin aspart

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Diabetes
Sponsor
Novo Nordisk A/S
Enrollment
719
Locations
1
Primary Endpoint
HbA1c
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

Registry
clinicaltrials.gov
Start Date
December 2, 2003
End Date
March 3, 2005
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Type 2 diabetes
  • •Duration of type 2 diabetes for at least 6 months since diagnosis
  • •Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
  • •BMI below 40 kg/m2
  • •HbA1c between 7-12%
  • •Able and willing to perform self-monitoring of capillary blood glucose

Exclusion Criteria

  • •Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
  • •Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
  • •Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • •Known or suspected allergy to trial product or related products
  • •Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
  • •Receipt of any investigational drug within 4 weeks prior to this trial
  • •Previous participation in this trial

Outcomes

Primary Outcomes

HbA1c

Time Frame: after 6 months of treatment

Secondary Outcomes

  • Incidence of hypoglycaemic episodes
  • Adverse events
  • Difference of HbA1c change between the two groups(after 13 weeks of treatment)
  • Fasting plasma glucose of treatment(after 13 and 26 weeks)
  • Change in weight

Study Sites (1)

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