NCT00469092|CompletedPhase 4Results

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

A Multi-national, Open-labelled, Randomised, Parallel Group, 4 Week run-in and 26 Weeks Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Insulin naïve Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

BIASP-17312006-003288-29

Study Type

interventional

Target

480

Locations

14 countries

Sites

Timeline

RegisteredMay 2007

StartedMay 2007

CompletionApr 2008

Brief Summary

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

480

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started May 2007

Shorter than P25 for phase_4 diabetes

Geographic Reach

14 countries

65 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

11 months study duration

Study Start

First participant enrolled

May 1, 2007

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2007

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

January 6, 2010

Completed

Last Updated

February 23, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

May 3, 2007

Results QC Date

November 30, 2009

Last Update Submit

January 5, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Glycosylated Haemoglobin A1c (HbA1c)
Glycosylated Haemoglobin A1c measured in blood samples after 26 weeks of treatment.
After 26 weeks of treatment

Secondary Outcomes (5)

9-point Self-measured Plasma Glucose Profiles
After 26 weeks of treatment
Number of Subjects Achieving the Treatment Target for Glycosylated Haemoglobin A1c (HbA1c)
After 26 weeks of treatment
Treatment Satisfaction as Measured by the Diabetes Medication Satisfaction Questionnaire (Diab MedSat)
After 26 weeks of treatment
Number of Hypoglycaemic Episodes
Weeks 0-26
Number of Subjects Reporting Treatment Emergent Adverse Events
Weeks 0-26

Study Arms (2)

BIAsp 30

EXPERIMENTAL

Drug: biphasic insulin aspartDrug: metforminDrug: glimepiride

Glargine

ACTIVE COMPARATOR

Drug: insulin glargineDrug: metforminDrug: glimepiride

Interventions

biphasic insulin aspartDRUG

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

BIAsp 30

insulin glargineDRUG

Treat-to-target dose titration scheme. The titration scheme is based on the previous 3 days fasting plasma glucose (FPG) measurements.

Glargine

metforminDRUG

Tablets, 2550 mcg. Administered once daily.

BIAsp 30Glargine

glimepirideDRUG

Tablets 2 mg. 4, 6 or 8 mg administered once daily.

BIAsp 30Glargine

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes
Treatment with OADs (Oral Anti-Diabetic Drugs) for more than 6 months
Ongoing stable treatment with metformin for at least 2 months
Ongoing stable treatment with minimum half maximal dose of any insulin secretagogue for at least 2 months
Insulin naive
HbA1c (glycosylated haemoglobin A1c) between 7.0% and 11.0% (inclusive of both values)

You may not qualify if:

Metformin contraindication according to local practice
TZD (thiazolidinedione) treatment for the last 5 months before trial start
Systemic treatment with any corticosteroid 3 months before trial start
Any disease or condition which according to the Investigator would interfere with the trial

Contact the study team to confirm eligibility.