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NCT00624364 Clinical Trial

Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00624364
Other study ID # BIASP-1579
Secondary ID
Status Completed
Phase Phase 4
First received February 15, 2008
Last updated January 5, 2017
Start date May 2004
Est. completion date May 2005

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority South Africa: Medicines Control Council
Study type Interventional

Clinical Trial Summary

This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 140
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Currently treated with maximum doses of any kind of OAD alone or any kind of oral combination therapy for at least 2 months

- Body mass index (BMI) below 40.0 kg/m2

- HbA1c between 7.5-13.0%

Exclusion Criteria:

- History of drug or alcohol dependence

- Mental incapacity, unwillingness or language barriers precluding adequate

- Subjects previously screened to participation or having already participated in this trial

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

- Known or suspected allergy to trial products or related products

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart

• metformin

Locations
Country Name City State
South Africa Novo Nordisk Investigational Site Benoni
South Africa Novo Nordisk Investigational Site Bloemfontein
South Africa Novo Nordisk Investigational Site Bloemfontein Free State
South Africa Novo Nordisk Investigational Site Brits North West
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Durban KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Kimberley
South Africa Novo Nordisk Investigational Site Pietermaritzburg KwaZulu-Natal
South Africa Novo Nordisk Investigational Site Pretoria Gauteng
South Africa Novo Nordisk Investigational Site Richards Bay

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

Naiker P, Makan HA, Kedijang T, Kong LLL, Omar MAK & the BIAsp-1579 Study Group. Effects of Once-Daily Biphasic Insulin Aspart 30 with Metformin versus Twice-Daily Biphasic Insulin Aspart 30 in South African Type 2 Diabetes Subjects. Society for Endocrino

Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Effect of biphasic insulin aspart 30/70 (BIAsp30) in combination with metformin on glycaemic control in subjects with type 2 diabetes not optimally controlled on oral antidiab

Naiker P, Makan HA, Omar MAK, Kedijang T, Kong LLL, the BIAsp-1579 Study Group. Efficacy of biphasic insulin aspart 30/70 with metformin on glycaemic control in poorly-controlled type 2 diabetes. IDF 2006 2006; 23(Suppl 4): 339 (P940)

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after 24 weeks of treatment No
Secondary Plasma glucose profiles No
Secondary Cardiovascular risk factors No
Secondary Incidence of hypoglycaemic episodes No
Secondary Adverse events No
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