Type 1 Diabetes Mellitus MedDRA version: 12.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus MedDRA version: 12.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent MedDRA version: 12.1 Level: LLT Classification code 10012610 Term: Diabetes mellitus loss of control
Conditions
Interventions
Product Name: SKP-1052 Modified-Release Tablets
Product Code: SKP-1052
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: TERBUTALINE SULFATE
CAS Number: 23031325
Concentration unit: mg
Sponsors
SkyePharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of Type 1 DM and daily use of insulin therapy for at least one year. 2. Male or female subjects, aged between 18 and 50 years inclusive. 3. HbA1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Untreated proliferative retinopathy and/or nephropathy with a serum creatinine concentration greater than upper limit of normal at screening. 2. Known coronary, cerebral or peripheral vascular disease, Hypertrophic Obstructive Cardio -Myopathy (HOCM) (previously called idiopathic hypertrophic subaortic stenosis), tachycardia, tachyarrhythmia, uncontrolled hypertension and /or autonomic neuropathy dysfunction. 3. Patients with active chest pain, shortness of breath and fatigue on exertion within the last 12 months. 4. Clinically significant abnormal safety or laboratory (hematology, biochemistry, urinalysis) screening tests as judged by the Investigator. 5. Female subjects of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive methods include sterilization, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner). Male subjects who are sexually active and not surgically sterilised, who or whose partner are not using adequate contraceptive methods [adequate contraceptive measures include that the subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%)]. 6. Presence of a significant medical disorder (including epilepsy, or any other cause of seizures, psychiatric, sleep or behavioural disorders) that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol. 7. Severe hypoglycaemia resulting in seizure or experienced loss of consciousness in the previous 3 months. 8. Known hypersensitivity to terbutaline. 9. Asthma which has been medically treated within 6 months before screening. 10. Treatment with systemic or inhaled corticosteroids in the last 3 months. 11. Active infection (if at the time of the scheduled visit an infection is present, the visit will be deferred). 12. Subjects with a history of HIV, hepatitis B or hepatitis C. 13. Current treatment with oral and topical (eye) B-blockers and use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study. 14. Treatment with ephedrine, phenylephrine, phenylpropanolamine, or pseudoephedrine 48 hours prior to the visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred). 15. Anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organised sport). 16. Significant blood loss (more than 500 mL) within the last 3 months prior to screening. 17. Significant history of alcoholism or drug/chemical abuse or positive result alcohol breath test at screening visit. 18. Participated in another investigational study where the study drug was received within 90 days prior to the Screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the pharmacodynamic (PD) effects of SKP-1052 and immediate-release terbutaline on nocturnal glucose levels based on mean nadir blood glucose at 0-10 hrs post-dose (21:00 hr - 07:00 hr).;Secondary Objective: • To assess the mean blood glucose concentration during overnight sampling at 0-10 hrs post-dose (21:00 hr - 07:00 hr) between SKP-1052, immediate-release terbutaline and placebo • To assess the time spent with nocturnal blood glucose levels < 63 mg/dL (or 3.5 mmol/L) at 0-10 hrs post-dose (21:00 hr - 07:00 hr) between SKP-1052, immediate-release terbutaline and placebo. • To assess morning blood glucose concentration at 10 hrs post-dose (07:00 hr) • To assess the safety of SKP-1052 based on number of AEs/SAEs and on morning glucose levels at 10 hrs post-dose (07:00 hr). • To compare the plasma pharmacokinetic (PK) profile between SKP-1052 and immediate-release terbutaline. • To explore the correlation of SKP-1052 pharmacokinetics with its pharmacodynamic effects on glucose levels in type 1 DM insulin treated patients (PK/PD correlation) ;Primary end point(s): • Mean nadir blood glucose concentration at time frame: 0-10 hrs post-dose (21:00 hr – 07:00 hr). | — |
Countries
Germany
Outcome results
None listed