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

NCT01140542 | Completed Phase 2

• 1 other identifier: BY217/M2-401
• Study Type: interventional
• Target: 487
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Diabetes Mellitus Type 2; Roflumilast

Outcome Measures

Primary Outcomes (1)

• Mean change in HbA1c [percent] from baseline to the last study visit (Vlast)

  Baseline to last visit

Secondary Outcomes (5)

• 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

• 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)

Study Arms (2)

Roflumilast

ACTIVE COMPARATOR

500µg, once daily

Drug: Roflumilast

Placebo

PLACEBO COMPARATOR

Drug: Roflumilast

Interventions

Roflumilast DRUG

500µg, once daily

Placebo; Roflumilast

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Related Links

• BY217-M2-401-RDS-2009-01-14-.pdf

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• AstraZeneca AstraZeneca

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 9, 2010
• Study Start: August 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2008
• Last Updated: October 26, 2016

Record last verified: 2016-09