InsuJet 1: A randomised, open label study to evaluate the efficacy, safety and tolerability of insulin aspart administered by InsuJet device or by subcutaneous injection in people with type 1 diabetes mellitus.
- Conditions
- Type 1 DiabetesMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12612000711819
- Lead Sponsor
- Baker IDI Heart and Diabetes Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1. Patient has given informed consent obtained before any trial-related activities.
2. Type 1 diabetes defined as patient on insulin treatment within one year of diagnosis.
3.Insulin treatment: on any insulin regimen for more than one year and on stable insulin basal-bolus regimen (defined as total daily dose of insulin not varying by > 20% from usual total daily dose) for greater than or equal to 3 months at the time of inclusion. Patient should have known insulin to carbohydrate ratio for calculating the bolus dose of rapid acting insulin analogue.
4. HbA1c less than or equal to 10%.
5. Age between 18 and 65 years.
6. BMI between 18 and 40 kg/m2
1. Known or suspected allergy to any of the trial products, including the food product used for the meal tolerance test.
2. History of major hypoglycaemic episodes, defined as hypoglycaemic events requiring external assistance within the last year.
3. Unstable angina, myocardial infarction or heart failure (NYHA class III-IV)less than or equal to 3 months of inclusion.
4. Seated BP more than or equal to 180/100 mmHg.
5. Impaired hepatic function (ALT alanine transaminase > 2.5 x upper reference limit of the local laboratory.)
6. Impaired renal function (eGFR MDRD < 30 ml/min/1.73m2).
7. Pregnancy at time of inclusion.
8. Mental incapacity, unwillingness, language barrier or other factor that in the investigator’s opinion precludes adequate understanding of the trial procedure or cooperation with trial site personnel.
9.Abuse of alcohol or narcotics
10. Known or suspected gastro paresis, or previous gastric surgical procedure that may interfere with gastric emptying (e.g. gastric laparoscopic banding, gastric stapling and partial gastrectomy).
11. Regular use of gastric prokinetic agents or other agents known to affect the motility of the stomach, such as anticholinergic agents (topical eye drops are allowed) or tricyclic antidepressants within 2 days of inclusion.
12. Glucocorticoid use within 7 days of inclusion (excluding inhaled or topical steroid).
13.Receipt of any investigational product within 30 days prior to inclusion in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in glucose concentration (Glu exc) defined as (Cmax glu - baseline glu) where Cmax glu = maximal post prandial plasma glucose level (from t = +15 mins to t =+ 240 mins) and baseline glu = mean of plasma glucose concentration at t = - 10 mins and t = 0 mins.[Timepoint: 4 hrs after the start of the meal test.]
- Secondary Outcome Measures
Name Time Method Area under the glucose concentration-time curve (AUC)glu (0-240) defined as AUC from t = 0 mins to t = +240 mins calculated by the trapezoid rule.[Timepoint: 4 hrs after the start of the meal test.];Patient device preference, assessed by end of study questionnaire by the name InsuJet study questionnaire[Timepoint: End of the study];Relative injection pain, assessed by visual analogue scale (VAS)[Timepoint: At end of each meal tolerance test.]