The primary objective of the study is to demonstrate non-inferiority of an insulin regimen using insulin glargine as the basal insulin with Exubera as the mealtime insulin, compared to a regimen using insulin glargine as the basal insulin and…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint is the change from baseline to week 52 in HbA1c
(%).
Secondary outcome
1. Hypoglycemic event rates during the entire study
2. Percentage of subjects who obtained an HbA1c < 8 %,< 7%, <6.5%, and > 8% at
52 weeks.
3. Percentage of subjects with >0.5, >0.7 and >1.0% absolute reduction in HbA1c
levels at 52 weeks from baseline levels.
4. Percentage of subjects who attain target FPG values 4.0 * 6.5 mmol/l at each
evaluation from baseline to 52 weeks.
5. Change in fasting plasma glucose from baseline to endpoint and change in
fasting and post-prandial blood glucose from baseline to 52 weeks based on
glucometer data and in-hospital assessments.
6. Change in insulin antibody levels and body weight from baseline to 52 weeks.
7. Change in body weight and body mass index from baseline to 52 weeks.
8. Change in basal and prandial insulin doses from baseline to 52 weeks.
9. Blood glucose values determined by home-monitored blood glucose (HMBG) from
baseline to 52 weeks.
10. Subject reported health state, quality of life (as measured by physical,
physiological and work and daily role functioning) and diabetes treatment
satisfaction from baseline to 52 weeks.
11. Change in fasting lipids from baseline to 52 weeks.
Background summary
The new way of administration with Exubera® makes it possible for diabetes
patients to treat themselves in a non-invasive way. This study should show that
the glycemic controle after 52 weeks of treatment of Exubera® given in
combination with Lantus® is not inferior comared to Humalog® in combination
with Lantus®.
Study objective
The primary objective of the study is to demonstrate non-inferiority of an
insulin regimen using insulin glargine as the basal insulin with Exubera as the
mealtime insulin, compared to a regimen using insulin glargine as the basal
insulin and insulin lispro as the mealtime insulin in terms of glycemic control
(HbA1c) after 52 weeks of treatment with each treatment regimen.
Study design
This is a randomized open-label, parallel-group outpatient and inpatient study
with a 4-week run-in period, and a 52-week treatment period. Half of the
subjects will receive an inhaled insulin regimen and half a subcutaneous
insulin regimen. All subjects will receive insulin glargine as basal regimen.
This study contains three sub-studies that are outlined in Appendices 4, 5 and
6 of the protocol.
Intervention
Patients will be randomised to one of the two treatment groups, being: Humalog
and Lantus or Exubera and Lantus.
Study burden and risks
Patients visit a dietician at week -3. Patients will have to perform home blood
glusoce monitoring by means of a bloodglucose meter.
This is part of the dialy routine for diabetes patients. Although for the study
more measurements need to be done.
During the study questionnaires need to be completed, 7 times.
A brief physical examination will be performed 14 times during the study.
A spirometry will be performed at least once. For patients randomised on
Exubera this will be done three times (in total).
Patients are expected to follow the studyprocedures as described in the
protocol during the duration of the study.
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Nederland
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Nederland
Listed location countries
Age
Inclusion criteria
1. Subjects with type 1 diabetes mellitus
2. Age: > 18 years
3. For the 2 months prior to screening, subjects must have been on a stable insulin regimen involving at least 3 injections daily of insulin or an insulin analogue
4. Screening (week-4) HbA1c between 5.5% and 9.0% inclusive
5. Body Mass Index * 30
6. The investigator will be responsible for obtaining written informed consent prior to the subject participating in the study
Exclusion criteria
1. Pregnant or lactating females, or females planning to become pregnant during the study
2. Subjects on insulin pump treatment as part of their MDI regime during the 2 months prior to screening
3. Subjects with *brittle* diabetes or a predisposition to severe hypoglycemia
4. Some pulmonary, cardiovascular, neurological, phychological and metabolic conditions (see page 17/18 of the protocol)
5. Concomitant therapy with systemic glucocorticoids
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2004-001557-29-NL |
| CCMO | NL13503.018.06 |