Back to resultsEfficacy 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)
Primary Purpose
Diabetes Mellitus Type 2
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Diabetes Mellitus Type 2, Roflumilast
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Roflumilast
Placebo
Arm Description
500µg, once daily
Outcomes
Primary Outcome Measures
Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01140542
Brief Title
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
Diabetes Mellitus Type 2, Roflumilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
487 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
500µg, once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Description
500µg, once daily
Primary Outcome Measure Information:
Title
Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)
Time Frame
Baseline to last visit
Secondary Outcome Measure Information:
Title
Mean change in HbA1c from baseline to each scheduled post-randomization visit
Title
Mean change from baseline to each scheduled post-randomization visit and Vlast in blood parameters
Description
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
Title
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
Title
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
Title
Time to event (study withdrawal, time to study withdrawal due to an adverse event (AE) and time to lack of efficacy (LOE)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4496&filename=BY217-M2-401-RDS-2009-01-14-.pdf
Description
BY217-M2-401-RDS-2009-01-14-.pdf
Learn more about this trial
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
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