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Completed

NCT Number: NCT00537303

Comparison of the Blood Sugar Lowering Effect and Safety of Two Insulin Treatments in Type 2 Diabetes

This trial is conducted in Europe, Africa and the United States of America (USA).

The aim of this trial is to compare the safety and efficacy of two different insulin treatments, the "basic" and the "advanced" treatment 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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Århus C, Denmark

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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 mellitus for more than 6 months
  • HbA1c (glycosylated haemoglobin A1c) between 7.5 % and 10.0% at trial initiation (screening)
  • BMI (Body Mass Index) less than 40 kg/m2
  • Basal insulin treatment for at least 3 months (NPH once or twice daily, insulin glargine or detemir once daily)
  • Treatment with one to 3 OADs

Exclusion criteria

  • Known or suspected allergy to trial products or related products
  • Women who are pregnant, are breast-feeding or intend to become pregnant within the next 48 weeks
  • Previous participation in any trial including this for the last 6 months
  • Use of more than 1 U/kg of basal insulin daily at trial initiation (screening)

Treatment and study plan

insulin detemir

Drug

Treat-to-target dose titration scheme (individually adjusted dose) for a once daily injection s.c. (under the skin)

insulin aspart

Drug

Administered 1 - 3 times daily, at largest prandial increment, injection s.c. (under the skin)

Primary outcomes

  1. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: week 36

    Analysed for the full analysis set.

  2. Glycosylated Haemoglobin A1c (HbA1c)

    Time frame: week 36

    Measured for the Per Protocol analysis set.

Secondary outcomes

  1. Hypoglycaemic Episodes

    Time frame: Weeks 0-36

    Number of hypoglycaemic episodes from Week 0 to Week 36, defined as major, minor or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L (56 mg/dL). Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

  2. Biochemistry: Serum Alanine Aminotransferase

    Time frame: week 36

    Alanine aminotransferase was measured in serum at week 36. Serum samples were analysed at a central laboratory.

  3. Haematology: Haemoglobin Measured in Blood

    Time frame: week 36

    Haemoglobin was measured in blood samples at week 36. Blood samples were analysed at a central laboratory.

  4. Cardiovascular Risk Marker: High-sensitivity C-reactive Peptide

    Time frame: week 36

    High-sensitivity C-reactive peptide was measured in serum at week 36. Serum samples were analysed at a central laboratory.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of the Efficacy and Safety of Step-wise Addition of Short Acting Insulin Analogue Insulin Aspart to Once Daily Insulin Detemir and Oral Anti-diabetic Treatment in Patients With Type 2 Diabetes

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 1, 2007
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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