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Completed

NCT Number: NCT01868542

A Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Insulin Detemir Titration Algorithms After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment With or Without Other Anti-diabetic Drugs (OADs)

This trial is conducted in Asia. The aim of the trial is to compare the glycaemic control of Levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other anti-diabetic drugs (OADs).

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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, Daejeon, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Diagnosed with type 2 diabetes mellitus at least 3 months prior to Visit 1 (week -2)
  • - Treatment with at least 1000 mg metformin per day with/without other OADs at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to Visit 1
  • - Insulin-naïve subjects
  • - HbA1c above or equal to 7.5% by central laboratory analysis
  • - Body mass index (BMI) below or equal to 35.0 kg/m^2

Exclusion criteria

  • - Female who is breast-feeding
  • - The receipt of any investigational product within 4 weeks prior to Visit 1
  • - Any contraindication to insulin detemir according to the domestic labelling
  • - Anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase [MAO] inhibitors)
  • - Clinically significant diseases which, in the investigator's opinion, may confound the results of the trial or pose additional risk in administering trial product
  • - Any conditions that the investigator judges would interfere with trial participation or evaluation of the results

Treatment and study plan

insulin detemir

Drug

Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.

Primary outcomes

  1. Change in Glycosylated Haemoglobin A1c (HbA1c) From Baseline.

    Time frame: Week 0, week 20

    Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment. Only the subjects in the full analysis set with HbA1c values after 20 weeks of treatment were included.

Secondary outcomes

  1. Change in HbA1c

    Time frame: Week 0, week 12

    Change in HbA1c at 12 weeks of treatment from visit 2.

  2. Proportion of Subjects Achieving HbA1c Below 7.0%

    Time frame: Week 20

    Responder was a dichotomous endpoint (responder/non-responder) that was defined based on whether a subject had met the ADA HbA1c target at end of trial (HbA1c < 7.0% at end of trial) during 20 weeks of treatment.

  3. Change in Fasting Plasma Glucose From Baseline

    Time frame: week 0, week 12

    Change in fasting plasma glucose from baseline.

  4. Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours.

    Time frame: For 20 weeks of treatment and over 24 hours

    A hypoglycaemic episode was defined as treatment emergent if the onset of the episode occurred after the first administration of the investigational medicinal product (IMP), and no later than the last day on trial product. Hypoglycaemic episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 inclusive. All plasma glucose values: · equal or below 3.9 mmol/L (70 mg/dL) or · higher than 3.9 mmol/L (70 mg/dL) when they occur in conjunction with hypoglycaemic symptoms.

  5. Change in Fasting Plasma Glucose From Baseline

    Time frame: Week 0, week 20

    Change in fasting plasma glucose from baseline.

  6. Incidence of Adverse Events

    Time frame: Week 20

    A treatment emergent adverse event (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than the day of visit 22.(week 20)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 20-week, Randomised, Multi-centre, Open-labelled Trial Comparing the Glycaemic Control of Levemir® Administered Once Daily According to Two Titration Algorithms (3-0-3 Algorithm and 2-4-6-8 Algorithm) After 20 Weeks in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Treatment in Korea

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 4, 2013
Registry last updated
Mar 3, 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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