NCT00537303|CompletedPhase 4Results

Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN304-18332007-000123-18

Study Type

interventional

Target

296

Locations

11 countries

Sites

Timeline

RegisteredOct 2007

StartedOct 2007

CompletionMar 2009

Brief Summary

This trial is conducted in Europe, Africa and the United States of America (USA). The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment in type 2 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

296

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Oct 2007

Geographic Reach

11 countries

66 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

September 28, 2007

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed

Same day until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

August 13, 2010

Completed

Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

September 28, 2007

Results QC Date

July 16, 2010

Last Update Submit

January 30, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Glycosylated Haemoglobin A1c (HbA1c)
Analysed for the full analysis set.
week 36
Glycosylated Haemoglobin A1c (HbA1c)
Measured for the Per Protocol analysis set.
week 36

Secondary Outcomes (4)

Hypoglycaemic Episodes
Weeks 0-36
Biochemistry: Serum Alanine Aminotransferase
week 36
Haematology: Haemoglobin Measured in Blood
week 36
Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide
week 36

Study Arms (2)

Advanced

EXPERIMENTAL

Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Drug: insulin detemirDrug: insulin aspart

Basic

ACTIVE COMPARATOR

Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.

Drug: insulin detemirDrug: insulin aspart

Interventions

insulin detemirDRUG

Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)

AdvancedBasic

insulin aspartDRUG

Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)

Advanced

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes mellitus for more than 6 months
HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
BMI (Body Mass Index) less than 40 kg/m2
Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
Treatment with one to 3 OADs

You may not qualify if:

Known or suspected allergy to trial products or related products
Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
Previous participation in any trial including this for the last 6 months
Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Contact the study team to confirm eligibility.