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OpenTrials
Completed

NCT Number: NCT00592969

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

This trial is conducted in South America. The aim of this trial is to evaluate the efficacy of metformin plus biphasic insulin aspart or insulin NPH on blood glucose control in subjects with 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Mariano Acosta S/n, Argentina

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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 insulin NPH or are insulin-naive
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-11.0%

Exclusion criteria

  • Participation in any other clinical trial involving investigational products within the last 3 months
  • History of drug or alcohol dependence
  • Known impaired hepatic function
  • Known or suspected allergy to human insulin NPH, insulin aspart or any component of the composition

Treatment and study plan

metformin

Drug

biphasic insulin aspart

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. PPBG values

  2. Glucose profiles

  3. Hypoglycemia

  4. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Evaluation of Efficacy and Safety of Metformin Plus Biphasic Insulin Aspart or Insulin NPH in Subjects With Type 2 Diabetes

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 14, 2008
Registry last updated
Feb 24, 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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