NCT01589653|CompletedPhase 4Results

Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients

A 20-week Study Comparing Patient-adjusted Versus Physician-adjusted Titration of BIAsp 30 Combined With Metformin in Type 2 Diabetes Patients Uncontrolled on NPH Insulin

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

BIASP-3968U1111-1125-7572

Study Type

interventional

Target

155

Locations

6 countries

Sites

Timeline

RegisteredMay 2012

StartedMay 2012

CompletionJul 2015

Brief Summary

This trial is conducted in Africa and Asia. The aim of the trial is to compare patient-adjusted versus physician-adjusted titration of BIAsp 30 combined with metformin in type 2 diabetes patients uncontrolled on NPH insulin.

Trial Health

On Track

Trial Health Score

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

Enrollment

155

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline

Completed

Started May 2012

Longer than P75 for phase_4 diabetes

Geographic Reach

6 countries

15 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

3.1 years study duration

First Submitted

Initial submission to the registry

April 30, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2012

Completed

24 days until next milestone

Study Start

First participant enrolled

May 26, 2012

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2015

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

August 9, 2016

Completed

Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

3.1 years

First QC Date

April 30, 2012

Results QC Date

June 29, 2016

Last Update Submit

June 8, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c From Baseline
Change in HbA1c (%) from baseline to the end of the treatment period.
Week 0, week 20

Secondary Outcomes (4)

Change in Fasting Plasma Glucose (FPG) (Laboratory Values) From Baseline
Week 0, week 20
Number of Hypoglycaemic Episodes During the Trial From Baseline
Week 20
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)
Week 0, week 20
Change in Patient Reported Outcomes: Treatment-Related Impact Measures for Diabetes (TRIM-D)-Treatment Burden
Week 0, week 20

Study Arms (2)

Subject-driven titration

EXPERIMENTAL

Drug: biphasic insulin aspart 30

Investigator-driven titration

EXPERIMENTAL

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30DRUG

Dose individually adjusted by the subjects themselves according to the titration algorithm every second week. Administered subcutaneously (s.c., under the skin) twice daily.

Subject-driven titration

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 screening
Currently treated with a NPH insulin for at least 3 months prior to 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 screening
HbA1c between 7.0% and 10.0% (both inclusive). (One re-test within one week of screening visit is allowed. The last sample will 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 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 is allowed. The last sample will be conclusive.)
Impaired kidney function with serum creatinine above or equal to 133 µmol/L (1.5 mg/dL) for males and above or equal to 124 µmol/L (1.4 mg/dL) for females. (One re-test within one week of screening visit is allowed. The last sample will be conclusive.)
Cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
Previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations)
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
Known proliferative retinopathy or maculopathy requiring treatment

Contact the study team to confirm eligibility.