Glucagon enhanced insulin absorption in Diabetes Mellitus type 1
Phase 1
Active, not recruiting
- Conditions
- Diabetes mellitus type 1Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- CTIS2022-502455-57-01
- Lead Sponsor
- St. Olavs Hospital HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1. DM1 for at least 1 year., 2.Age 18 – 70 years, 3.Last known HbA1c <86 mmol/mol (< 10.0%), 4.Treated with continuous SC insulin infusion (CSII) by an insulin pump or with multiple daily insulin injections (MDII).
Exclusion Criteria
1.Pregnant women or women trying to conceive (women will not be screened by a pregnancy test)., 2.Any chronic disease, including psychiatric illnesses, judged incompatible with participation in the study., 3.Unfit for participation for any reason as judged by the investigators, 4. Known hypersensitivity to glucagon or any of the excipients of the drug formulation, 5. Known phaeochromocytoma
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate if micro-doses of glucagon at the same site as subcutaneous insulin delivery enhances the absorption of insulin and reduces postprandial glucose excursions in patients with diabetes mellitus type 1;Secondary Objective: To test two doses of glucagon, 0.1 mg and 0.01 mg;Primary end point(s): Area under the glucose curve for the first 60 minutes.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Area under glucose curve for any other time span during the first 3 hours.;Secondary end point(s):Area under the insulin curve for any time span during the first 3 hours;Secondary end point(s):Area under the glucagon curve for any time span during thefirst 3 hours.;Secondary end point(s):Pharmacokinetic estimates for insulin.;Secondary end point(s):Pharmacokinetic estimates for glucagon.;Secondary end point(s):Thermal camera measurements.;Secondary end point(s):Laser doppler flowmetry measurements.