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

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00605020

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	719
Study Start Date:	December 2003
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605020

Locations

Austria

Wien, Austria, A 1090
Germany, EK Uni Tübingen

Tübingen, EK Uni Tübingen, Germany, 72072
Switzerland

Lugano, Switzerland, 6900

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Jens Larsen

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:	NN304-1558
Study First Received:	January 17, 2008
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00605020 History of Changes
Health Authority:	Austria: Federal Ministry for Health and Women; Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic

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 November 09, 2009