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 Withou

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Metformin

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 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