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 August 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: August 11, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 11, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on October 23, 2014