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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00624364
First received: February 15, 2008
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: biphasic insulin aspart
Drug: metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Biphasic Insulin Aspart Plus Metformin to Biphasic Insulin Aspart Monotherapy in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 24 weeks of treatment ]

Secondary Outcome Measures:
  • Plasma glucose profiles
  • Cardiovascular risk factors
  • Incidence of hypoglycaemic episodes
  • Adverse events

Enrollment: 140
Study Start Date: May 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624364

Locations
South Africa
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1827
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1829
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2001
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0116
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4001
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, South Africa, 4091
Novo Nordisk Investigational Site
Pietermaritzburg, KwaZulu-Natal, South Africa, 3235
Novo Nordisk Investigational Site
Brits, North West, South Africa, 0250
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7708
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7800
Novo Nordisk Investigational Site
Benoni, South Africa, 1500
Novo Nordisk Investigational Site
Bloemfontein, South Africa, 27 51
Novo Nordisk Investigational Site
Kimberley, South Africa, 8301
Novo Nordisk Investigational Site
Richards Bay, South Africa, 3900
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
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
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
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)

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00624364     History of Changes
Other Study ID Numbers: BIASP-1579
Study First Received: February 15, 2008
Last Updated: January 5, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Metformin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017