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

Diabetes Mellitus Type 2 Clinical Trial

— FORTUNA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140542
• Other study ID #: BY217/M2-401
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2010
• Last updated: October 24, 2016
• Start date: August 2006
• Est. completion date: March 2008

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health RisksRomania: National Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesUkraine: State Pharmacological Center - Ministry of HealthChile: Ministerio de Salud Instituto de Salud Pública de Chile (ISPCH)Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 487
• Est. completion date: March 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Roflumilast
500µg, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)		Baseline to last visit	No
Secondary	Mean change in HbA1c from baseline to each scheduled post-randomization visit			No
Secondary	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-a, intercellular adhesion molecule 1 (ICAM-1), E-selectin, plasminogen activator inhibitor 1 (PAI-1), adiponectin, and leptin		No
Secondary	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			No
Secondary	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			No
Secondary	Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE)			No

External Links

•   BY217-M2-401-RDS-2009-01-14-.pdf