NCT00184600|CompletedPhase 3Results

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

A 36-month, Multi-centre, Open-label, Randomised, Parallel-group Trial Comparing the Safety, Efficacy and Durability of Adding a Basal Insulin Versus a Twice Daily Insulin Mixture Versus a Meal-time Rapid-Acting Insulin in Subjects With Type 2 Diabetes Inadequately Controlled on Therapy With Oral Agents, and Assessing the Requirement for More Complex Insulin Regimens to Achieve and Maintain Glycaemic Control, Their Efficacy and Durability

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN304-16132004-000514-38

Study Type

interventional

Target

708

Locations

2 countries

Sites

Timeline

RegisteredSep 2005

StartedNov 2004

CompletionAug 2009

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 (oral anti-diabetic drug) treatment in subjects with type 2 diabetes and to verify the safety of use (number and severity of episodes of hypoglycaemia, body weight and side effects).

Trial Health

On Track

Trial Health Score

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

Enrollment

708

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Nov 2004

Longer than P75 for phase_3 diabetes

Geographic Reach

2 countries

63 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

4.8 years study duration

Study Start

First participant enrolled

November 1, 2004

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed

2 years until next milestone

Results Posted

Study results publicly available

July 25, 2011

Completed

Last Updated

March 9, 2017

Status Verified

January 1, 2017

Enrollment Period

4.8 years

First QC Date

September 13, 2005

Results QC Date

May 10, 2011

Last Update Submit

January 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

HbA1c (Glycosylated Haemoglobin) at Month 12
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Baseline, Month 12
HbA1c (Glycosylated Haemoglobin) at Month 36
HbA1c values offer evidence of the efficacy and durability of the insulin regimens.
Baseline, Month 36

Secondary Outcomes (13)

Percentage of Participants (Total Participants and the Subset of Participants Who Did Not Have an Hypoglycaemic Episode) Achieving a Month 12 Value in HbA1c Below or Equal to 6.5%
Month 12
Percentage of Participants Achieving a Month 36 Value in HbA1c Below or Equal to 6.5%
Month 36
Number of Hypoglycaemic Events Per Participant Per Year at Month 12 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
Month 12
Number of Hypoglycaemic Events Per Participant Per Year at Month 36 for All Participants and the Subset Who Achieved Target HbA1c Below or Equal to 6.5%
Month 36
Percentage of Participants Who Required A Second Insulin Therapy by Month 12
Month 12
+8 more secondary outcomes

Study Arms (3)

Insulin detemir (basal insulin)

EXPERIMENTAL

Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen.

Drug: insulin detemir

Insulin aspart (prandial insulin)

ACTIVE COMPARATOR

Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen.

Drug: biphasic insulin aspart

Biphasic insulin aspart 30 (biphasic insulin)

ACTIVE COMPARATOR

Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen.

Drug: insulin aspart

Interventions

biphasic insulin aspartDRUG

Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart

Insulin aspart (prandial insulin)

insulin detemirDRUG

Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart

Insulin detemir (basal insulin)

insulin aspartDRUG

Treat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir

Biphasic insulin aspart 30 (biphasic insulin)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Insulin naive
On OAD treatment for at least 4 months with metformin, a sulphonylurea or a combination
Body Mass Index (BMI) below or equal to 40.0 kg/m2
HbA1c (glycosylated haemoglobin): 7.0%-10% (both inclusive)

You may not qualify if:

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

Contact the study team to confirm eligibility.