Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Proof of Concept Clinical Study
NCT ID: NCT01140542
Last Updated: 2016-10-26
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
487 participants
INTERVENTIONAL
2006-08-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Roflumilast
500µg, once daily
Roflumilast
500µg, once daily
Placebo
Roflumilast
500µg, once daily
Interventions
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Roflumilast
500µg, once daily
Eligibility Criteria
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Inclusion Criteria
* patients with diagnosis of type 2 diabetes according to American Diabetes Association (ADA) criteria and inadequately controlled on diet and exercise alone
* HbA1c at baseline: ≥7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania)
* BMI between ≥26 and ≤35 kg/m2
* willingness of patient to check his/her blood glucose with equipment provided by the sponsor during the treatment phase in case of hypo-/hyperglycemia episodes
* willingness to adhere to the physician's advise to comply with diet and exercise
Exclusion Criteria
* patients diagnosed with hemoglobinopathies, hemolytic anemia or other diseases which interfere with HbA1c measurement
* non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidism
* reported gain or loss of more than 5 percent of body weight within the last 2 months prior to V0
* treatment with any diabetes medication prior to V0
* treatment with any weight-loss medication within 3 months prior to V0
* treatment with any not allowed medication or nutrition additives
* clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
* clinically significant cardiac abnormalities (diagnosed clinically, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation
* participation in a clinical study with study medication for weight loss or type 2 diabetes
Patients were randomized after 2 weeks of the baseline period, if the following criteria were fulfilled:
* judged to be clinically stable
* tablet compliance ≥80 percent and ≤125 percent
* HbA1c in the range of 7.5 percent to 8.5 percent (up to 9 percent in Mexico, Ukraine and Romania) tested at V0 by the central laboratory
35 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Related Links
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BY217-M2-401-RDS-2009-01-14-.pdf
Other Identifiers
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BY217/M2-401
Identifier Type: -
Identifier Source: org_study_id