|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
7 September 2021 |
|
Main ID: |
EUCTR2004-001258-94-ES |
|
Date of registration:
|
26/05/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera®) on Glycemic Control in Patients with Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents.
Ensayo abierto de un año y de grupos paralelos para evaluar el impacto de la disponibilidad de insulina a inhalada (Exubera) sobre el control glucémico de pacientes ambulatorios orales. - N/A
|
|
Scientific title:
|
One Year, Open-Label Outpatient, Parallel Group Trial Assessing the Impact of the Availability of Inhaled Insulin (Exubera®) on Glycemic Control in Patients with Type 2 Diabetes Mellitus Who Are Poorly Controlled on a Minimum of Two Oral Anti Diabetic Agents.
Ensayo abierto de un año y de grupos paralelos para evaluar el impacto de la disponibilidad de insulina a inhalada (Exubera) sobre el control glucémico de pacientes ambulatorios orales. - N/A |
|
Date of first enrolment:
|
07/01/2005 |
|
Target sample size:
|
1100 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001258-94 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
|
|
Phase:
|
Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
|
|
|
Countries of recruitment
|
|
Germany
|
Italy
|
Spain
|
United Kingdom
| | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Age > 35 years and < 80 years with a diagnosis of type 2 diabetes made > 6 months prior to study entry, as defined by the American Diabetes Association (Diabetes Care 25:S5-S20, 2002).2. HbA1c > 8.0% at screening 3. Body Mass Index (BMI) > 23 kg/m2 and < 40 kg/m2 (See BMI Table Appendix E).4. Patients must have documentation of a fully dilated ophthalmologic exam performed within 1 year of screening in accordance with local guidelines. The documentation must be obtained prior to randomization. This information is of importance e.g., in case proliferative retinopathy is diagnosed while aggressive glucose lowering is considered in the study. 5. Currently treated and on a stable dose at least two oral hypoglycemic agents for at least 3 months prior study entry at the following minimum doses: · Sulfonylurea dosage greater than or equal to one half the maximum recommended dosage i.e. glimepiride > 4 mg; glipizide, including GITS ³ 10 mg; or glyburide ³ 10 mg, or Glynase® ³ 3 mg; Gliclazide in any dosing ³ 180 mg daily, or Gliclazide MR in any dosing ³ 15 mg daily· Metformin dosage ³ 1500 mg daily including Glucophage XR® · Fixed combination of glyburide and metformin e.g., Glucovance® in any dosing in which glyburide ³ 10 mg and metformin > 1000 mg daily· Rosiglitazone e.g., Avandia® in any dosing ³ 4 mg daily· Pioglitazone e.g., Actos® in any dosing ³ 30 mg daily· Repaglinide e.g., Prandin® in any dosing ³ 2 mg before meals· Nateglinide e.g., Starlix® in any dosing ³ 60 mg before meals· Acarbose e.g., Precose™ in any dosing ³ 300 daily· Miglitol e.g., Glyset® in any dosing ³ 150 mg daily6. Written informed consent obtained PRIOR to performing screening evaluations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1.Type 1 diabetes 2.Known allergy to insulin 3.Smoking: current or any in the past 6 months; smoking is not permitted at any time during the study4.Current treatment with insulin or discontinued from insulin within the past three months5.“Brittle” diabetes or a predisposition to severe hypoglycemia, i.e., 2 or more severe hypoglycemic episodes within the past 6 months, or any hospitalization or emergency room visit due to poor diabetic control (other than for hypoglycemia) within the past 6 months. Similarly, during the baseline run-in period, any patient with more than one severe hypoglycemic episode, or any hospitalization or emergency room visit due to poor diabetic control (other than for hypoglycemia), will be excluded from randomization. Severe hypoglycemia is defined in Section 10.11.2. of the protocol.6. Metabolic Conditions:a) Significant hypoglycemia risk e.g., history of >2 severe (DCCT) hypoglycemic episodes within past 6 months, known adrenal insufficiency, symptomatic autonomic neuropathy b) Current chronic inhaled or systemic corticosteroid treatment likely to be of metabolic effect (prednisone equivalent >2 mg/day); intercurrent treatment at a higher dose is allowed if treatment duration does not exceed 2 weeks7. Active Liver disease; ALT > 1.5 times the upper limit of normal reference range for the central lab at screening. Evidence within the preceding six months of hepatic dysfunction e.g., AST, ALT, two and a half (2.5) times the upper limit of normal or hepatic disease, e.g., hepatitis, jaundice, cirrhosis or history of developing abnormal liver function tests (LFTs) on thiazolidinediones.8.Pulmonary Conditions:a)Frankly abnormal PFTs at Week –1, defined as DLco >120% or <70%; TLC >130% or <70%; or FVC or FEV1 <70% of predicted.b)Clinically significant abnormalities on screening chest X-ray (or chest MRI). A screening chest x-ray or chest MRI is defined as a chest x-ray or chest MRI obtained at screening or 6 months prior to screening. Subjects with radiographically stable and clinically insignificant abnormalities need not be excluded (e.g., localized scarring or calcified granulomata). Documentation of stability requires comparison with previous radiographs obtained at least 6 months earlier. c) Significant pulmonary diseases including:·History of moderate or severe asthma including those with daily symptoms and/or require daily use of inhaled short acting beta2-agonist.·History of moderate or severe COPD including those requiring regular use of one or more bronchodilators (beta2-agonists, anticholinergics, methylxanthines). However, short acting bronchodilators used as needed (prn) are allowed. ·Poorly-controlled asthma, clinically significant obstructive pulmonary disease or other significant respiratory disease. 9.Cardiovascular conditions:a)Significant cardiovascular dysfunction and/or history including hospitalization within the preceding six months, e.g., congestive heart failure or serious arrhythmia, myocardial infarction, cardiac surgery, recurrent syncope, transient ischemic attacks or cerebrovascular accident.b) Poorly-controlled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg) on two readings (sitting).c)Abnormal screening ECG: i)predominant rhythm other than normal sinusii)A-V block greater than first degree iii)resting heart rate > 100 or < 50 bpm The principal investigator, or other designated physician at each site, will be responsible for deciding the cli
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Type 2 diabetes mellitus
MedDRA version: 7
Level: LLT
Classification code 10012601
|
|
Intervention(s)
|
Product Name: Exubera (inhaled insulin)
Product Code: CP-464005
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin human
Current Sponsor code: CP-464005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: Exubera (inhaled insulin)
Product Code: CP-464005
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Insulin human
Current Sponsor code: CP-464005
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
|
|
Primary Outcome(s)
|
|
Main Objective: To demonstrate that mean reduction in HbA1c after 52 weeks (approx. 12 months) is greater in patients to whom inhaled insulin is made available compared to patients to whom it is not.
|
|
Primary end point(s): The primary objective of this study is to demonstrate that mean the reduction in HbA1c after 52 weeks (approx. 12 months) of treatment is greater in patients to whom inhaled insulin is made available compared to patients to whom it is not. Thus, the primary efficacy variable is the difference in HbA1c between baseline (Week -1) and the end of the treatment period at week 52, in the intention-to-treat (ITT) population
|
Secondary Objective: Secondary objectives of the study, although not literally stated, are reflected in the secondary endpoints. These endpoints are designed to show patients with inhaled option are more likely and quickly to use insulin, more likely to achieve and maintain glycemic control, and less likely to discontinue from the study. Other safety or efficacy aspects, such as hypoglycemia, weight gain, lipid profile, insulin antibodies and adverse events will also be studied. In addition, pharmacoeconomic impact will also be evaluated.
|
|
Secondary ID(s)
|
|
A2171018
|
|
N/A
|
|
2004-001258-94-DE
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 22/11/2004
Contact:
|
|