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Effect of insulin detemir and insulin glargine on blood glucose control in subjects with type 2 diabetes

Phase 4
Completed
Conditions
Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2
Registration Number
CTRI/2009/091/000161
Lead Sponsor
ovo Nordisk AS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
52
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 DPP-4 inhibitors) for at least 3 months

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

HbA1c 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/m2

Age 18 years and above

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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