Diabetes Mellitus type 2
Conditions
Interventions
Product Name: SUN E7001
Pharmaceutical Form: Nasal powder
Current Sponsor code: SUN E7001
Other descriptive name: GLP-1
Concentration unit: mg milligram(s)
Concentration number: 1,2-
Pharmaceutical fo
Sponsors
Hvidovre Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnose of Type 2 diabetes in accordance with WHO criteria. • Duration of treatment with diet or diet in combination with metformine treatment > 3 months prior to inclusion in the trial. • HbA1c > 7.5 % and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subjects treated with the following medications during the month prior to inclusion: o Corticosteroids, (except for inhaled steroids due to allergy). o Hormones (except oestrogen's). • Proliferative retinopathy. • Known or suspected abuse of drugs, alcohol or narcotics. • Subjects with hypoglycaemic unawareness. • Recurrent major hypoglycaemia more than once during the last year. • Impaired hepatic function (ASAT and/or ALP > 2 times normal range). • Impaired renal function (S-creatinine > 150 µmol/l (1.7 mg/dl)). • Cardiac problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate efficacy on blood glucose and plasma levels of drug;Secondary Objective: Safety assessment;Primary end point(s): •Area under the glucose, insulin and C-peptide curves and the dynamic changes of insulin and C-peptide secretion rates. •Suppression of free fatty acid and glucagon. •Area under the GLP-1 curves and dynamic changes in GLP-1 concentrations. •Area under the GIP curves. •Sensitivity of the beta-cell to changes in glucose during the breakfast meal. •Hypoglycaemic events. •Abdominal discomfort evaluated by the Gastrointestinal System Rating Scale (GRSR) | — |
Countries
Denmark
Outcome results
None listed