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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effect of Biphasic Insulin Aspart 50 Compared to Biphasic Insulin Aspart 30 Both in Combination With Metformin in Chinese Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627445
• Other study ID #: BIASP-1858
• Status: Completed
• Phase: Phase 3
• First received: February 22, 2008
• Last updated: October 14, 2014
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
• metformin
Tablets, 500 - 2000 mg, once, twice or three times daily
• biphasic insulin aspart 50
Treat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin A1c (HbA1c)	Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)	week 0, week 16	No
Secondary	The Percentage of Subjects Achieving HbA1c Treatment Targets	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%.	week 16	No
Secondary	Change and Daily Average in 8-point Plasma Glucose	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.	week 0, week 16	No
Secondary	Change and Daily Average in Prandial Plasma Glucose Increment	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.	week 0, week 16	No
Secondary	The Total Increase in Total Daily Insulin Dose Per Body Weight	The total increase in total daily insulin dose per body weight from baseline (week 0) to end of treatment (week 16).	week 0, week 16	No
Secondary	Change in Body Weight	Change in body weight from baseline (week 0) to end of treatment (week 16)	week 0, week 16	No
Secondary	Number of Hypoglycaemic Episodes	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.	weeks 0-16	Yes
Secondary	Number of Nocturnal Hypoglycaemic Episodes	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.	weeks 0-16	Yes

External Links

•   Clinical Trials at Novo Nordisk