Inhaled pre-prandial human insulin with the AERx® iDMS plus metformin versus rosiglitazone plus metformin in type 2 diabetes: a 26-week, open-label, multicentre, randomised, parallel trial to investigate efficacy and safety

• Conditions: Type II diabetes; MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2006-000796-15-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

1. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject)
2.Diagnosis of type 2 diabetes according to clinical judgement
3.Current treatment with one or two OAD(s) (insulin secretagogues, insulin sensitizers, metformin, glitazones, alpha-glucosidase inhibitors) for = 2 months. Subjects on monotherapy should be at least on half maximum dose for = 2 months
4. 7.5% = HbA1c = 11.0% in subjects on OAD monotherapy, and 7.0% = HbA1c = 10.0% in subjects on OAD combination therapy (analysis from central laboratory)
5. FEV1 = 70 % of predicted value
6.Males and females, age = 18 years
7.Body mass index of (BMI) = 40.0 kg/m2
8.Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
9. Able and willing to be treated with metformin (up to three times daily) in combination with pre-prandial inhaled insulin using the AERx or tablet treatment

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.Previous participation in this trial. Participation is defined as randomisation
2.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice [for Germany, adequate contraception is: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner. For United Kingdom, adequate contraceptive measures are sterilisation, intra-uterine device, oral contraceptives or consistent use of barrier methods])
3.Known or suspected allergy to trial products or related products
4.Current regular smoking or regular smoking* within the last 6 months. *Regular smoking defined as one cigarette or an equivalent amount of smoking tobacco per day or a positive urine cotinine test on laboratory test, except if resulting from non-inhalable tobacco products
5.Chest X-ray with any clinically significant abnormalities evaluated by a radiologist
6.Unresolved symptoms and signs of an upper respiratory tract infection (URTI) within 3 weeks prior to screening
7.Current acute or chronic pulmonary disease (excluding asthma) including chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, sarcoidosis, and pulmonary fibrosis
8.History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator
9.Cardiac disease defined as: decompensated heart failure (NYHA class I to IV), unstable angina pectoris within the past 6 months of study enrolment, myocardial infarction within the past 12 months and a clinically significant history of arrhythmias or conduction delays on ECG over the past 12 months
10.Clinically significant, active (or over the past 12 months) disease of the gastrointestinal, neurological, genitourinary, haematological systems
11.Severe uncontrolled treated or untreated hypertension (systolic blood pressure = 180 mmHg or sitting diastolic blood pressure = 100 mmHg)
12.Impaired hepatic function defined as screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) = 2.5 times upper normal range (one re-test analysed at the central laboratory within one week is permitted with the last sample being conclusive)
13.Renal insufficiency defined as serum creatinine = 1.4 mg/dL (= 126 µmol/L) for males and = 1.3 mg/dL (= 111 µmol/L) for females, (one retest within a week is permitted)
14.History of proliferative retinopathy or maculopathy requiring treatment
15.Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
16.Positive screening for Hepatitis B antigen or Hepatitis C antibody
17.Treatment with systemic steroids within the past 2 months prior to screening
18.Current addiction to alcohol or substances of abuse as judged by the Investigator
19.Any conditions that the Investigator judges would interfere with trial participation or evaluation of results
20.Mental incapacity, unwillingness or language barrier precluding adequate understanding or
cooperation in the trial
21.Participated in another clinical trial and received an investigational drug within the last 4 weeks
22.Previous treatment with inhaled insulin, other than treatment with AERx, for more than a total of seven days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified