Diabetes Mellitus Type 2
Conditions
Keywords
Diabetes Mellitus Type 2, Roflumilast
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.
Interventions
DRUGRoflumilast
500µg, once daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c [percent] from baseline to the last study visit (Vlast) | Baseline to last visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in HbA1c from baseline to each scheduled post-randomization visit | — | — |
| Mean change from baseline to each scheduled post-randomization visit and Vlast in blood parameters | — | blood parameters: serum lipids (high-density-lipoprotein-cholesterol \[HDL\], low-density-lipoprotein-cholesterol \[LDL\], and triglycerides \[TG\]), fasting plasma glucose (FPG), fructosamine, glycerol, free fatty acids \[FFA\], plasma insulin, fasting pro-insulin, cholesterol, c-reactive protein (CRP), interleukin-6 (IL-6), TNF-α, intercellular adhesion molecule 1 (ICAM-1), E-selectin, plasminogen activator inhibitor 1 (PAI-1), adiponectin, and leptin |
| 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 | — | — |
| 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 | — | — |
| Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE) | — | — |
Outcome results
None listed