Clinical trial NCT01140542: 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
Official title: Efficacy of 500µg Roflumilast Once Daily Versus Placebo Over 12 Weeks in Patients With Diabetes Mellitus Type 2. A Double Blind, Parallel Group, Phase IIb, Proof of Concept Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus Type 2
Roflumilast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 487
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)
timeFrame: Baseline to last visit
Secondary outcomes:
measure: Mean change in HbA1c from baseline to each scheduled post-randomization visit
measure: Mean change from baseline to each scheduled post-randomization visit and Vlast in blood parameters
measure: Mean change from baseline to each scheduled post-randomization visit and Vlast based on a 5-hour period post meal area under the curve (AUC) for FFA, glycerol, glucose, glucagons, insulin, and C-peptide
measure: Mean change in body weight, waist and hip circumference, waist to hip ratio, and body mass index (BMI) from baseline to each scheduled post-randomization visit and Vlast
measure: Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE)
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: