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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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01868542
First received: May 30, 2013
Last updated: January 18, 2017
Last verified: January 2017

May 30, 2013
January 18, 2017
June 2013
May 2015   (Final data collection date for primary outcome measure)
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.
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline [ Time Frame: Week 0, week 20 ]
Complete list of historical versions of study NCT01868542 on ClinicalTrials.gov Archive Site
  • Change in HbA1c [ Time Frame: Week 0, week 12 ]
    Change in HbA1c at 12 weeks of treatment from visit 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.
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: week 0, week 12 ]
    Change in fasting plasma glucose from baseline.
  • 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.
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: Week 0, week 20 ]
    Change in fasting plasma glucose from baseline.
  • 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)
  • Change in HbA1c [ Time Frame: Week -2, week 12 ]
  • Proportion of Subjects Achieving HbA1c Below 7.0% [ Time Frame: Week 20 ]
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: week 0, week 12 ]
  • Incidence of nocturnal hypoglycaemic episodes (23:00−05:59) [ Time Frame: At 20 weeks of treatment and over 24 hours ]
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: Week 0, week 20 ]
  • Incidence of Adverse Events [ Time Frame: Week 20 ]
Not Provided
Not Provided
 
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)
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
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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
Drug: insulin detemir
Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.
  • Experimental: 3-0-3 Algorithm
    A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values, the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
    Intervention: Drug: insulin detemir
  • Experimental: 2-4-6-8 Algorithm
    A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial. During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
    Intervention: Drug: insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01868542
NN304-3994
U1111-1132-9267 ( Other Identifier: WHO )
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP