Does the drug Galvus enhance the effects of a protein preload to reduce blood glucose concentrations after a meal?

Phase 4

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

• Registration Number: ACTRN12612001005842
• Lead Sponsor: Professor Michael Horowitz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

Patients with type 2 diabetes (taking a stable dose of metformin, greater than or equal to 1500 mg/day for at least 3 months prior to the study)
-Body mass index of 25-35 kg/m2
Aged between 20-75 years, will be included in the study.

Exclusion Criteria

(1) significant gastrointestinal symptoms; disease or surgery
(2) inability to monitor blood glucose at home with a glucometer
(3) current use of any prescribed or non-prescribed medications, that may affect gastrointestinal function (except for metformin) within 48 hours of the study (e.g. domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St John's Wort)
(4) current use of ACE inhibitors
(5) epilepsy
(6) cardiovascular (coronary heart disease, heart attack or failure, stroke) or respiratory disease (COPD, cystic fibrosis)
(7) any other significant illness as assessed by the investigator
(8) intake of > 20 g alcohol on a daily basis
(9) smokers (cigarettes, cigars, marijuana)
(10) donation of blood in the 12 weeks prior to enrolment in the study. Participants will also be instructed to abstain from donating blood for 12 weeks after study completion. A screening blood sample will be taken to ensure that only individuals with normal haemoglobin and iron levels are included in the study.
(11) consumption of a vegetarian diet
(12) inability to comprehend study protocol
(13) known lactose intolerance, intolerance or allergy to whey, allergy to vildagliptin
(14) liver function tests and creatinine clearance outside the following ranges
*Alanine aminotransferase (ALT)0 -55 U/l
*Alkaline phosphatase30 - 110 U/l
*Aspartate transaminase0 - 45 U/l
*Bilirubin 6 - 24 mmol/l
Calculated creatinine clearance will be determined as follows:
Cr clearance = [140 - age (years) x weight (kg)] / serum creatinine (micromol/L)
with a creatinine clearance cut-off of <50 ml/min AND/OR serum creatinine concentration >0.12mmol/l will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood glucose levels[Venous blood samples (~10 mL) will be taken immediately before the preload administration (t = -30 min), and at t = -15, 0, 15, 30, 60, 90, 120, 180 and 240 min for the measurements of blood glucose.]