Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 15, 2009

Start Date ^ICMJE

November 2004

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects who achieve HbA1c = 6.5% without hypoglycaemia [ Time Frame: in the last 4 weeks of year 1/year 3 ] [ Designated as safety issue: No ]
Efficacy and durability of the insulin regimens [ Time Frame: over a 12-36 months following a treatment algorithm ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Proportion of subjects who achieve HbA1c ≤ 6.5% without hypoglycaemia in the last 4 weeks of year 1/year 3, Efficacy and durability of the insulin regimens over a 12-36months following a treatment algorithm

Change History

Complete list of historical versions of study NCT00184600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
body weight [ Time Frame: after 52 or 156 weeks of treatment ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: after 52 or 156 weeks of treatment ] [ Designated as safety issue: No ]
Blood glucose [ Time Frame: after 52 or 156 weeks of treatment ] [ Designated as safety issue: No ]
Hypoglycaemia [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Body weight
Quality of Life
Blood glucose
Hypoglycaemia
Adverse events

Descriptive Information

Brief Title ^ICMJE

Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes

Official Title ^ICMJE

3 Year Efficacy and Safety Comparison of Adding Insulin Detemir, Biphasic Insulin Aspart 30 or Insulin Aspart to Oral Antidiabetic Drug Treatment in Type 2 Diabetes.

Brief Summary

This trial is conducted in Europe. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added to current OAD treatment in type 2 diabetes and to verify the safety of use ( number and severity of episodes of hypoglycaemia, body weight and side effects).

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: biphasic insulin aspart
Treat-to-target, s.c. injection, twice daily plus option for insulin aspart
Other Names:
- BIasp
- NovoMix 30
- NovoLog Mix 70/30
Drug: insulin detemir
Treat-to-target, s.c. injection, once or twice daily plus option for insulin aspart
Other Names:
- NN304
- Levemir
Drug: insulin aspart
Treat-to-target, s.c. injection, twice daily plus option for insulin detemir
Other Names:
- ANA
- NovoRapid
- NovoLog

Study Arms / Comparison Groups

A: Active Comparator
Intervention: Drug: insulin detemir
B: Active Comparator
Intervention: Drug: biphasic insulin aspart
C: Active Comparator
Intervention: Drug: insulin aspart

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

713

Completion Date

August 2009

Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 Diabetes
Insulin naive
On OAD treatment
BMI = 40.0 kg/m2
HbA1c7.0%-10% (both inclusive)

Exclusion Criteria:

Proliferative retinopathy
Recurrent major hypoglycaemia
Cardial problems
Uncontrolled hypertension
Impaired hepatic or renal function

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

Ireland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00184600

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-1613

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jens Larsen, MD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

September 2009

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