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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: September 22, 2016
Last verified: September 2016

May 30, 2013
September 22, 2016
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 ] [ Designated as safety issue: No ]
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 20 weeks of treatment.
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01868542 on ClinicalTrials.gov Archive Site
  • Change in HbA1c [ Time Frame: Week 0, week 12 ] [ Designated as safety issue: No ]
    Change in HbA1c at 12 weeks of treatment from visit 2.
  • Proportion of Subjects Achieving HbA1c Below 7.0% [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose from baseline.
  • Incidence of Hypoglycaemic Episodes : Nocturnal (23:00-05:59) and Over 24 Hours. [ Time Frame: At 20 weeks of treatment and over 24 hours ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose from baseline.
  • Incidence of Adverse Events [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Proportion of Subjects Achieving HbA1c Below 7.0% [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Incidence of nocturnal hypoglycaemic episodes (23:00−05:59) [ Time Frame: At 20 weeks of treatment and over 24 hours ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose From Baseline [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: Week 20 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
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.
    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.
    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
Both
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
No
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
September 2016

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