Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

Phase 4

Completed

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

• Registration Number: NCT00669864
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-04-30
• Study First Posted: 2008-05-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2010-04-29
• Results First Submitted QC: 2010-06-04
• Results First Posted: 2010-07-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

Inclusion Criteria

• Type 2 diabetes
• Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
• HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
• BMI (Body Mass Index) maximum 40 kg/m2

Exclusion Criteria

• Metformin contraindications according to local practice
• Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BIAsp 30-30	biphasic insulin aspart 30	Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily
BIAsp 30-30	metformin	Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (Glycosylated Haemoglobin A1c)	week 0, week 16	Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)

Secondary Outcome Measures

Name	Time	Method
Change in 8-point Plasma Glucose Profile	week 0, week 16	Summary of change in 8-point plasma glucose profile by week and time. The 8 time points measured were: Before each meal (breakfast, lunch and dinner), at 2 hours after each meal (breakfast, lunch and dinner), at bedtime, and at 3 AM, measured over 16 weeks of treatment
Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%	week 16	Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below or equal to 6.5% after 16 weeks of treatment
Hypoglycaemic Episodes	weeks 0-16	Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L or 56 mg/dL. Symptoms only if subject was able to treat her/himself and with either no plasma glucose or blood glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L or 56 mg/dL.
Percentage of Subjects Achieving HbA1c Less Than 7.0%	week 16	Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment
Hypoglycaemic Episodes, Diurnal/Nocturnal	weeks 0-16	Total number of hypoglycaemic episodes experienced in the trial from week 0 (baseline) to week 16 (end of treatment) during the day (diurnal) and the night (nocturnal).