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OpenTrials
Completed

NCT Number: NCT00598793

Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

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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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Concord, California, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Insulin naive Type 2 diabetes
  • Currently treated with OADs alone or combined with other treatment for at least 3 months
  • BMI below 40 kg/m2 and body weight below 125 kg
  • HbA1c greater than or equal to 8%

Exclusion criteria

  • Inability to tolerate metformin or contradictions to its use
  • Pregnant, breastfeeding or intention of becoming pregnant
  • Allergy to any of the trial products
  • Inability or unwillingness to perform SMBG

Treatment and study plan

biphasic insulin aspart

Drug

insulin glargine

Drug

metformin

Drug

pioglitazone

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 28 weeks of treatment

Secondary outcomes

  1. Postprandial glucose by 8-point SMBG

  2. Number of subjects achieving HbA1c below 7%

  3. Number of hypoglycemic episodes and adverse events

  4. Weight change

  5. Insulin dose

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Biphasic Insulin Aspart 70/30 + Metformin Compared to Insulin Glargine + Metformin in Type 2 Diabetes Failing OAD Therapy

Acronym: INITIATE

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jan 23, 2008
Registry last updated
Jan 9, 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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