Glucagon-like peptide 1 (GLP-1) for lowering plasma glucose in type 2-diabetic patients: A systematic comparison of intravenous and subcutaneous routes.

Phase 1

Completed

• Conditions: Type 2 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620000201976
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Study Completion: 2021-12-07
• Last Update Posted: 13 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Male and females aged 18 to 75 years (both included)
- Diagnosis of T2DM by ADA criteria
- Diabetes treatment for greater or equal to 3 months with:
* Basal insulin (glargine) or premixed insulin (e.g. Mixtard or Novomix),
* together with any combination of diet, metformin, sulfonylurea, thiazolidinedione, SGLT2 inhibitor, alpha-glucosidase inhibitor, or prandial insulin.
- Body mass index (BMI) 20 to 35 kg/m² (both included)
- Weight-stable ( less than or equal to 3% change in last 3 months)

Exclusion Criteria

- Use of insulin degludec (due to its very long half-life)
- Use of a DPP-4 inhibitor or GLP-1RA
- Patients with diagnosis of T1DM (based on islet autoantibodies)
- Patients with possible diabetes mellitus caused by diseases of the exocrine pancreas T3cDM (based on a history of alcohol intake greater or equal to 3 units daily, pancreatic disease, or steatorrhea)
-Impaired renal (eGFR less than 60mL/min as calculated by CKP-EPI formula) or liver function (transaminases more than or equal to 2 x ULN), iron deficiency (serum ferritin less than 20 µg/l) or anaemia (ie. haemoglobin less than 135g/L for men and less than 115g/L for women)
- Patients with contraindications to bilateral IV cannulation: history of mastectomy, axillary node clearance, axillary node radiotherapy, upper limb lymphedema and upper limb arteriovenous fistula for haemodialysis.
- Symptomatic ischaemic heart disease
- Pregnancy (pre-menopausal females will be using adequate contraception and record a negative pregnancy test on each study day)
- Patients with significant gastrointestinal (GI) symptoms (any upper GI symptom moderate” or worse on the PAGI- SYM questionnaire)
- Previous GI surgery (other than appendicectomy or cholecystectomy)
- HbA1c less than 7.0%
- Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes daily
- Other significant illness, including epilepsy, cardiovascular or respiratory disease
- Donation of blood within the previous 12 weeks
- Participation in any other research studies within the previous 3 months
- Inability to give informed consent
- Vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of subjects achieving a plasma glucose < 6.1 mmol/l (< 110 mg/dl)<br>[During entire infusion period (0-480 min) with blood sampling at following time points:<br>t = -15, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 390, 420, 450, and 480 min.];Number of subjects with more than negligible nausea, assessmed by visual analogue scale (VAS).[During entire infusion period (0-480 min) as measured at the following time points:<br>t = -15, 0, 90, 120, 210, 240, 330, 360, 450, 480 min.];Number of subjects with vomiting as assessed by clinical observation[During entire infusion period (0-480 min), any event.]