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

Phase 4

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01427920
• Lead Sponsor: Novo Nordisk A/S

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-08-31
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-07-03
• Results First Submitted QC: 2013-07-03
• Results First Posted: 2013-09-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

• 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)

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Exclusion Criteria

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subject-driven titration BIAsp 30 (BID) + metformin	biphasic insulin aspart 30	The subjects performed the titration of BIAsp 30 dose.
Investigator-driven titration BIAsp 30 (BID) + metformin	biphasic insulin aspart 30	The investigator performed the titration of BIAsp 30 dose.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose (FPG) (Central Laboratory Values)	Week 0, week 20	Estimated mean change from baseline in FPG after 20 Weeks of treatment
Number of Treatment Emergent Hypoglycaemic Episodes	Week 0 to week 20	A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of trial product, and no later than one day after product administration. Severe hypoglycaemic episodes were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Patient Reported Outcomes Evaluated: Treatment-Related Impact Measures for Diabetes (TRIM-D) - Total Score	Week 20	From the 20 TRIM-D items, an overall score was derived. The scores were transformed to a 0 - 100 scale with higher scores indicating a better health state.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Wirral, Merseyside, United Kingdom