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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909480

NN304-1768

Details and patient eligibility

About

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).

Enrollment: 457 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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457 participants in 2 patient groups

IDet

Experimental group

Description:

Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day

Treatment:

Drug: insulin detemir

IGlar

Active Comparator group

Description:

Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day

Treatment:

Drug: insulin glargine