Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

January 17, 2008

Last Updated Date

June 26, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c [ Time Frame: after 6 months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

HbA1c [ Time Frame: after 6 months of treatment ]

Change History

Complete list of historical versions of study NCT00605020 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of hypoglycaemic episodes [ Designated as safety issue: Yes ]
Adverse events [ Designated as safety issue: Yes ]
Difference of HbA1c change between the two groups [ Time Frame: after 13 weeks of treatment ] [ Designated as safety issue: No ]
Fasting plasma glucose of treatment [ Time Frame: after 13 and 26 weeks ] [ Designated as safety issue: No ]
Change in weight [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Incidence of hypoglycaemic episodes
Adverse events
Difference of HbA1c change between the two groups [ Time Frame: after 13 weeks of treatment ]
Fasting plasma glucose of treatment [ Time Frame: after 13 and 26 weeks ]
Change in weight

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin detemir
Drug: insulin aspart
Device: biphasic insulin aspart

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

719

Completion Date

March 2005

Primary Completion Date

March 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Germany, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00605020

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-1558

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jens Larsen

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP