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OpenTrials
Completed

NCT Number: NCT00624364

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Bloemfontein, Free State, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart

Drug

metformin

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 24 weeks of treatment

Secondary outcomes

  1. Plasma glucose profiles

  2. Cardiovascular risk factors

  3. Incidence of hypoglycaemic episodes

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 27, 2008
Registry last updated
Jan 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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