Phase 2
Completed N=229
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
Source: ClinicalTrials.gov NCT00754624 ↗Enrolled (actual)
229
Serious AEs
13.1%
Results posted
Oct 2014
Primary outcomePrimary: Annual Rate of Change in FEV1 From Baseline to End of Study — -0.048 Liters per year
Summary
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Rate of Change in FEV1 From Baseline to End of Study |
-0.048 | — |
| SECONDARY Annual Rate of Change in FVC From Baseline to End of Study |
-0.058 | — |
| SECONDARY Annual Rate of Change in DLCo From Baseline to End of Study |
-0.311 | — |
| SECONDARY Change in HbA1c From Baseline to Last Measurement on Study Drug (Maximum of 48 Months) |
0.20 | — |
| SECONDARY Change in FPG From Baseline to Last Study Measurement on Treatment (Maximum of 48 Months) |
-5.34 | — |
| SECONDARY Change in Weight in kg From Baseline to End of Study |
1.42 | — |
| SECONDARY High Resolution Computerized Tomography Scans of the Chest |
47; 147; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Previous completion of PDC-INS-0008 or MKC-TI-005
- Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial
- Subjects must be able to understand English or have access to validated primary language trial documents
- Written informed consent
Exclusion Criteria
- Drug or alcohol dependency
- Smokers (subjects are expected to remain non-smokers throughout their participation in this trial)
- Known hypersensitivity to the trial drug or to drugs of similar chemical structures
- Anemia (hemoglobin level < 11 g/dL for females or < 12 g/dL for males)
- Evidence of moderate or greater ketones in urine
- Women of childbearing potential practicing inadequate birth control. (Adequate birth control is defined as using oral contraceptives, condoms or diaphragms with spermicide, intrauterine devices, Depo-Provera, contraceptive patches or surgical sterilization)
- Women who are pregnant
- Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation
Data sourced from ClinicalTrials.gov (NCT00754624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.