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Comparison of NN1250 with insulin glargine in type 2 diabetes

Phase 3
Completed
Conditions
Health Condition 1: E08-E13- Diabetes mellitusHealth Condition 2: null- Diabetes Mellitus, Type 2
Registration Number
CTRI/2009/091/000804
Lead Sponsor
ovo Nordisk AS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
687
Inclusion Criteria

Type 2 diabetes mellitus for at least 6 months

Currently treated with oral antidiabetic drugs, treated with insulin or a combination of oral antidiabetic drugs and insulin for at least 3 months

For patients currently treated with oral antidiabetic drug: HbA1c 7-11%

For patients currently treated with insulin: HbA1c 7-10%

Body Mass Index (BMI) below or equal to 40.0 kg/m2

Age 18 years and older

Exclusion Criteria

Use GLP-1 receptor agonist (exenatide, liraglutide), rosiglitazone, DPP-IV inhibitors, a-glucosidase-inhibitors within the last 3 months prior to trial start
Cardiovascular disease, within the last 6 months
Uncontrolled treated/untreated severe hypertension
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
Cancer and medical history of cancer hereof

Study & Design

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