Overview

Effect of Insulin Detemir and Insulin Glargine on Blood Glucose Control in Subjects With Type 2 Diabetes

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Insulin
Insulin Detemir
Insulin Glargine
Insulin, Globin Zinc
Metformin
Criteria
Inclusion Criteria:

- Diagnosed with type 2 diabetes for at least 6 months

- Stable treatment with a total daily dose of at least 1500 mg metformin or maximum
tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas,
meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at
least 3 months

- Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed)

- HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory
analysis (one re-test within one week is allowed)

- Body Mass Index (BMI) less than or equal to 35.0 kg/m^2

Exclusion Criteria:

- Any contraindication to insulin detemir or insulin glargine according to the local
labelling

- Receipt of any investigational product within 4 weeks

- Anticipated change of dose of any systemic treatment with products, which in the
Investigator's opinion could interfere with glucose metabolism (e.g. systemic
corticosteroids)

- 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 other condition that the Investigator feels would interfere with trial
participation or evaluation of results