Effects of extended exposure to lixisenatide on gastric emptying and postprandial glycaemia in patients with type 2 diabetes treated with metformi

Phase 3

Completed

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

• Registration Number: ACTRN12616001059459
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-09
• Study Completion: 2018-09-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Males or females aged greater than 40 years
If females are premenopausal they must have had either a tubal ligation or hysterectomy i.e. are not fertile.
Type 2 diabetes treated with metformin for greater than or equal to 3 months
HbA1c between 6.5 and 9%
Duration of known diabetes greater than or equal to 2 years
Haemoglobin above the lower limit of the normal range (i.e. greater than 135 g/L for men and 115 g/L for women), and ferritin above the lower limit of normal (i.e. greater than 10 mcg/L)

Exclusion Criteria

Evidence of renal, hepatic or cardiovascular disease, pancreatitis, gastric surgery, or known gastroparesis. Renal disease: creatinine clearance (mL/min) will be calculated using the Cockcroft-Gault equation. Subjects will be excluded if creatinine clearance is estimated at less than 30 mL/min. Hepatic disease: subjects will be excluded if there is documented cirrhosis or transaminases or alkaline phosphatase elevated more than 2 times the upper limit of normal. Cardiovascular disease: admission to hospital with heart failure, myocardial infarction or stroke within previous 6 months.
Previous exposure to GLP-1 receptor agonists
Use of drugs potentially affecting gastrointestinal motility (opiates, anticholinergics, levodopa, clonidine, nitrates, , phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin)
Use of any agent other than metformin for control of glycaemia
Premenopausal females, unless they have had a tubal ligation or hysterectomy
Presence of definite autonomic nerve damage (as assessed by standardised cardiovascular reflex tests)
Participation in any research studies involving exposure to ionising radiation within the previous 12 months
Vegetarian diet
Intake of greater than 20 g alcohol on a daily basis, or cigarette smoking
Volunteers who have donated blood in the preceding 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified