NCT00624364

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started May 2004

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

February 15, 2008

Last Update Submit

January 5, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    after 24 weeks of treatment

Secondary Outcomes (4)

  • Plasma glucose profiles

  • Cardiovascular risk factors

  • Incidence of hypoglycaemic episodes

  • Adverse events

Interventions

biphasic insulin aspartDRUG
metforminDRUG

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Novo Nordisk Investigational Site

Bloemfontein, Free State, 9301, South Africa

Location

Novo Nordisk Investigational Site

Johannesburg, Gauteng, 1827, South Africa

Location

Novo Nordisk Investigational Site

Johannesburg, Gauteng, 1829, South Africa

Location

Novo Nordisk Investigational Site

Johannesburg, Gauteng, 2001, South Africa

Location

Novo Nordisk Investigational Site

Pretoria, Gauteng, 0116, South Africa

Location

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, 4091, South Africa

Location

Novo Nordisk Investigational Site

Pietermaritzburg, KwaZulu-Natal, 3235, South Africa

Location

Novo Nordisk Investigational Site

Brits, North West, 0250, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 7708, South Africa

Location

Novo Nordisk Investigational Site

Cape Town, Western Cape, 7800, South Africa

Location

Novo Nordisk Investigational Site

Benoni, 1500, South Africa

Location

Novo Nordisk Investigational Site

Bloemfontein, 27 51, South Africa

Location

Novo Nordisk Investigational Site

Kimberley, 8301, South Africa

Location

Novo Nordisk Investigational Site

Richards Bay, 3900, South Africa

Location

Related 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 Endocrinology, Metabolism and Diabetes of South Africa (SEMDSA); Country: South Africa City: Bloemfontein

    RESULT

  • 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 antidiabetic agents. EASD 2006 2006; 49(Suppl 1): 599

    RESULT

  • 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)

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 27, 2008

Study Start

May 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

ZA(15)