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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282451

Enrollment

Registered

2006-01-26

Start date

2006-02-28

Completion date

2006-08-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

Brief 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.

Interventions

DRUGbiphasic insulin aspart

DRUGinsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1c	At Visit 6 (14 weeks)

Secondary

Measure	Time frame
Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)	—

Countries

Egypt, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026