Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 3

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: metformin; Drug: biphasic insulin aspart 50

• Registration Number: NCT00627445
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2010-03-11
• Results First Submitted QC: 2010-03-11
• Results First Posted: 2010-03-31
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

Inclusion Criteria

• Type 2 diabetes
• Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
• HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
• FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
• BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Exclusion Criteria

• Metformin contraindications according to local practice
• Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIAsp 30-30	biphasic insulin aspart 30	Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
BIAsp 50-50-30	biphasic insulin aspart 30	Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
BIAsp 50-50-30	biphasic insulin aspart 50	Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
BIAsp 50-50-30	metformin	Biphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
BIAsp 30-30	metformin	Biphasic insulin aspart 30 administered before breakfast and dinner combined with metformin

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Total Increase in Total Daily Insulin Dose Per Body Weight	week 0, week 16	The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).
The Percentage of Subjects Achieving HbA1c Treatment Targets	week 16	The percentage of subjects who after 16 weeks of treatment met the glycosylated haemoglobin A1c (HbA1c) treatment targets below 7%, or below or equal to 6.5%.
Change and Daily Average in 8-point Plasma Glucose	week 0, week 16	Change in 8-point plasma glucose from baseline (week 0) to at end of treatment (week 16). 8-point plasma glucose was measured at following time points: Before each meal, 120 minutes after the start of each meal, at bedtime, and at 3:00 AM in the morning. Daily average was calculated at the end of treatment.
Change in Body Weight	week 0, week 16	Change in body weight from baseline (week 0) to end of treatment (week 16)
Number of Hypoglycaemic Episodes	weeks 0-16	Number of hypoglycaemic episodes occurring after baseline (week 0) to the end of treatment (week 16) in each treatment group. 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.
Change and Daily Average in Prandial Plasma Glucose Increment	week 0, week 16	Change in prandial (mealtime) plasma glucose increment from baseline (week 0) to end of treatment (week 16). Daily average prandial plasma glucose increment was calculated at end of treatment.
Number of Nocturnal Hypoglycaemic Episodes	weeks 0-16	Number of nocturnal hypoglycaemic episodes occurring after baseline (week 0) to end of treatment (week 16) in each treatment group. 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.