NCT01427920|CompletedPhase 4Results

Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes

SimpleMix™

A 20 Week Randomised, Multinational, Open Labelled, 2 Armed, Parallel Group Comparison of Twice Daily Subject Driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Versus Twice Daily Investigator-driven Titration of Biphasic Insulin Aspart (BIAsp) 30 Both in Combination With Metformin in Subjects With Type 2 Diabetes Inadequately Controlled on Basal Insulin Analogues

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

BIASP-38782010-024303-27U1111-1118-4096

Study Type

interventional

Target

348

Locations

6 countries

Sites

Timeline

RegisteredSep 2011

StartedSep 2011

CompletionJul 2012

Brief Summary

This trial was conducted in Asia, Europe and South America. The aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (HbA1c).

Trial Health

On Track

Trial Health Score

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

Enrollment

348

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Sep 2011

Shorter than P25 for phase_4 diabetes

Geographic Reach

6 countries

41 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

10 months study duration

First Submitted

Initial submission to the registry

August 31, 2011

Completed

1 day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

September 12, 2013

Completed

Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

August 31, 2011

Results QC Date

July 3, 2013

Last Update Submit

January 10, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in HbA1c (Glycosylated Haemoglobin) - FAS
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in full analysis set (FAS).
Week 0, week 20
Change in HbA1c (Glycosylated Haemoglobin) - PP
Estimated mean change from baseline in HbA1c after 20 Weeks of treatment in per protocol (PP) analysis set.
Week 0, week 20

Secondary Outcomes (5)

Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)
Week 0, week 20
Number of Treatment Emergent Hypoglycaemic Episodes
Week 0 to week 20
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Week 0
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Week 4
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score
Week 20

Study Arms (2)

Subject-driven titration BIAsp 30 (BID) + metformin

EXPERIMENTAL

The subjects performed the titration of BIAsp 30 dose.

Drug: biphasic insulin aspart 30

Investigator-driven titration BIAsp 30 (BID) + metformin

ACTIVE COMPARATOR

The investigator performed the titration of BIAsp 30 dose.

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.

Investigator-driven titration BIAsp 30 (BID) + metforminSubject-driven titration BIAsp 30 (BID) + metformin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Diagnosed with type 2 diabetes for a minimum of 12 months prior to Visit 1 (screening)
Currently treated with a basal insulin analogue for at least 3 months prior to Visit 1 (screening)
Stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional OAD treatment. The metformin treatment must have been stable for at least 2 months prior to Visit 1 (screening)
HbA1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
Body Mass Index (BMI) below or equal to 40.0 kg/m\^2
Able and willing to eat at least 2 main meals each day during the trial
Able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (SMPG), injection regimen and titrating themselves according to the protocol
Experience in performing self measured plasma glucose (SMPG)

You may not qualify if:

Treatment with any thiazolidinedione (TZD) and glucagon-like peptide-1 (GLP-1) receptor agonists or pramlintide within the last 3 months prior to Visit 1 (screening)
Impaired hepatic function defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
Impaired kidney function with serum creatinine above or equal to 133 micromol/L (1.5 mg/dL) for males and above or equal to 124 micromol/L (1.4 mg/dL) for females (one re-test within one week of screening visit was allowed. The last sample was to be conclusive)
Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmHg and/or diastolic blood pressure higher or equal to 100 mmHg)
Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. Previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (Visit 1)

Contact the study team to confirm eligibility.