Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes
NCT ID: NCT00660374
Last Updated: 2015-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
402 participants
INTERVENTIONAL
2008-02-29
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
insulin NPH
"Soft-treat-to-target" dose titration scheme, injection s.c.
B
EX1000
"Soft-treat-to-target" dose titration scheme, injection s.c.
Interventions
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insulin NPH
"Soft-treat-to-target" dose titration scheme, injection s.c.
EX1000
"Soft-treat-to-target" dose titration scheme, injection s.c.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
* Body Mass Index (BMI) less than or equal to 40 kg/m2
* HbA1c less than or equal to 9.5%
* FPG less than or equal to 12 mmol/L
Exclusion Criteria
* Treatment with more than 1 IU/kg NPH insulin daily
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Salvador, , Brazil
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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EX1000-1865
Identifier Type: -
Identifier Source: org_study_id
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