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 (FORTUNA)

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus Type 2

Treatments

Drug: Roflumilast

Study type

Interventional

Funder types

Industry

Identifiers

NCT01140542

BY217/M2-401

Details and patient eligibility

About

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.

Enrollment

487 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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