Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
Brief Summary
This study is a proof of concept study to confirm in a standardized manner the therapeutic efficacy of roflumilast in type 2 diabetes mellitus patients.
Eligibility Criteria
Inclusion
- given written informed consent
- 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
- Main
Exclusion
- patients diagnosed with type 1 diabetes or diabetes secondary to pancreatitis or resection of pancreas
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT01140542
Start Date
August 1 2006
End Date
March 1 2008
Last Update
October 26 2016
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