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 is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novo Nordisk A/S
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01868542
First received: May 30, 2013
Last updated: June 16, 2014
Last verified: June 2014

May 30, 2013
June 16, 2014
January 2013
January 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 ]
Same as current
Complete list of historical versions of study NCT01868542 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
    The subjects will have insulin detemir administered once daily. The dose will be titrated twice weekly with changes in dose of +/- 3 units if not on target.
  • Drug: insulin detemir
    The subjects will have insulin detemir administered once daily. The dose will be titrated twice weekly with changes in dose of 2, 4, 6, 8 units dependent on FPG (fasting plasma glucose) if not on target.
  • Experimental: 3-0-3 titration algorithm
    Intervention: Drug: insulin detemir
  • Active Comparator: 2-4-6-8 titration algorithm
    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.
 
Recruiting
140
January 2015
January 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 of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
  • 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
No
Contact: Novo Nordisk clinicaltrials@novonordisk.com
Korea, Republic of
 
NCT01868542
NN304-3994, U1111-1132-9267
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: MinJung Kim Novo Nordisk Pharma Korea Ltd.
Novo Nordisk A/S
June 2014

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