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Completed

NCT Number: NCT00605020

Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes

This trial is conducted in Europe.

The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily 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 3

Primary location

Novo Nordisk Investigational Site, Graz, Austria

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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
  • Duration of type 2 diabetes for at least 6 months since diagnosis
  • Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
  • BMI below 40 kg/m2
  • HbA1c between 7-12%
  • Able and willing to perform self-monitoring of capillary blood glucose

Exclusion criteria

  • Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
  • Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial product or related products
  • Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
  • Receipt of any investigational drug within 4 weeks prior to this trial
  • Previous participation in this trial

Treatment and study plan

insulin detemir

Drug

Other names: Levemir

insulin aspart

Drug

biphasic insulin aspart

Device

Primary outcomes

  1. HbA1c

    Time frame: after 6 months of treatment

Secondary outcomes

  1. Incidence of hypoglycaemic episodes

  2. Adverse events

  3. Difference of HbA1c change between the two groups

    Time frame: after 13 weeks of treatment

  4. Fasting plasma glucose of treatment

    Time frame: after 13 and 26 weeks

  5. Change in weight

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Comparison of Efficacy and Safety of Insulin Detemir in Combination With Insulin Aspart and Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus

Acronym: PreFER

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 30, 2008
Registry last updated
Jun 27, 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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