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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184600

Purpose

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).

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart Drug: insulin detemir Drug: insulin aspart	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	700
Study Start Date:	November 2004
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: insulin detemir Treat-to-target, s.c. injection, once or twice daily plus option for insulin aspart
B: Active Comparator	Drug: biphasic insulin aspart Treat-to-target, s.c. injection, twice daily plus option for insulin aspart
C: Active Comparator	Drug: insulin aspart Treat-to-target, s.c. injection, twice daily plus option for insulin detemir

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184600

Locations

Ireland

Dublin, Ireland
United Kingdom

Oxford, United Kingdom

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jens Larsen, MD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1613
Study First Received:	September 13, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00184600 History of Changes
Health Authority:	Ireland: Irish Medicines Board; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009