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OpenTrials
Completed

NCT Number: NCT00101751

INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study

This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.

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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 Clinical Trial Call Center

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 Diabetes

Treatment and study plan

biphasic insulin aspart

Drug

dietary regimen

Behavioral

Primary outcomes

  1. HbA1c and Incidence of hypoglycemia

    Time frame: After 24 weeks of treatment

Secondary outcomes

  1. Postprandial glucose from 8-point SMBG spontaneously reported adverse events; any changes from baseline

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy

Acronym: INITIATE plus

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 13, 2005
Registry last updated
Nov 2, 2023

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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