Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282451
• Other study ID #: BIASP-3024
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2006
• Last updated: October 27, 2016
• Start date: February 2006
• Est. completion date: August 2006

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of HealthEgypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 18 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetic subjects

• Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial

• HbA1c at least 12%

• Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

• History of drug or alcohol dependence

• Receipt of any investigational drug within the last month prior to this trial

• Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)

• Severe uncontrolled hypertension

• Recurrent severe hypoglycemia as judged by investigator

• Any disease or condition, which the Investigator feels, would interfere with the 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

• insulin aspart

Locations

Country	Name	City	State
Egypt	Novo Nordisk Investigational Site	Aghakhan
Egypt	Novo Nordisk Investigational Site	Giza
Saudi Arabia	Novo Nordisk Investigational Site	Jeddah
Saudi Arabia	Novo Nordisk Investigational Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		At Visit 6 (14 weeks)	No
Secondary	Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)			No

External Links

•   Clinical Trials at Novo Nordisk