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Completed

NCT Number: NCT00634842

Effect of Two Different Fasting Blood Glucose Targets on Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily

This trial is conducted in the United States of America. The aim of this trial is to explore how different fasting blood glucose targets affect glucose control in patients with type 2 diabetes, when patients are empowered to do dose adjustments themselves.

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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, Caguas, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • 1-3 oral treatments
  • Insulin naive
  • BMI (Body Mass Index) less than or equal to 45

Exclusion criteria

  • Pregnancy
  • Retinopathy
  • Cardiac disease
  • Uncontrolled hypertension
  • Recurrent hypoglycaemia

Treatment and study plan

insulin detemir

Drug

Treat-to-target dose titration scheme, s.c. injection, once daily. Fasting plasma glucose (FPG) titration target range of 70-90 mg/dL

Primary outcomes

  1. Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7%

    Time frame: week 20

    Percentage (%) of subjects reaching glycosylated haemoglobin A1c (HbA1c) less than 7% measured after 20 weeks of treatment

Secondary outcomes

  1. Percentage of Participants Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5%

    Time frame: week 20

    Percentage (%) of participants reaching glycosylated haemoglobin A1c (HbA1c) less than or equal to 6.5% measured after 20 weeks of treatment

  2. Change in Glycosylated Haemoglobin A1c (HbA1c) Percentage From Baseline

    Time frame: week -2, week 20

    Change in glycosylated haemoglobin A1c (HbA1c) percentage from baseline measured from week -2 to week 20

  3. Incidence of Hypoglycaemic Episodes (All, Major, Minor and Symptoms Only)

    Time frame: weeks 0-20

    Incidence of hypoglycaemic episodes (all, major, minor and symptoms only) occurring during the treatment period from week 0 to week 20. Classification was as follows:

    • If subject was unable to treat himself: Major incidence.
    • If subject could treat himself and plasma glucose was less than 3.1 mmol/l: Minor incidence.
    • If subject could treat himself and plasma glucose was equal to or greater than 3.1 mmol/l, or there was no plasma glucose measurement: Symptoms only.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Effect of Two Different Fasting Blood Glucose Titration Targets in Glucose Control in Patients With Type 2 Diabetes Using Insulin Detemir Once Daily in Combination With 1-3 Oral Agents

Acronym: TITRATE™

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2008
Registry last updated
Mar 10, 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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