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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669864
• Other study ID #: BIASP-1960
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2008
• Last updated: June 5, 2012
• Start date: November 2007
• Est. completion date: April 2009

Study information

• Verified date: June 2012
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 293
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Subcutaneous (under the skin) injection, twice daily
• metformin
Tablets, 1000 - 2000 mg daily

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 HbA1c (Glycosylated Haemoglobin A1c)	Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)	week 0, week 16	No
Secondary	Change in 8-point Plasma Glucose Profile	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	week 0, week 16	No
Secondary	Percentage of Subjects Achieving HbA1c Less Than 7.0%	Percentage of subjects achieving the treatment target of a glycosylated haemoglobin A1c (HbA1c) level below 7.0% after 16 weeks of treatment	week 16	No
Secondary	Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%	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	week 16	No
Secondary	Hypoglycaemic Episodes	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.	weeks 0-16	Yes
Secondary	Hypoglycaemic Episodes, Diurnal/Nocturnal	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).	weeks 0-16	Yes

External Links

•   Clinical Trials at Novo Nordisk