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.
Verified March 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: March 14, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline [ Time Frame: Week 0, week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: June 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3-0-3 titration algorithm 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.
Active Comparator: 2-4-6-8 titration algorithm 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868542

Contacts
Contact: Novo Nordisk clinicaltrials@novonordisk.com

Locations
Korea, Republic of
Recruiting
Daejeon, Korea, Republic of, 330-721
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: MinJung Kim Novo Nordisk Pharma Korea Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01868542     History of Changes
Other Study ID Numbers: NN304-3994, U1111-1132-9267
Study First Received: May 30, 2013
Last Updated: March 14, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Metformin
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014