A new combination therapy for the treatment of type 2 diabetes mellitus.

Phase 2

Completed

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

• Registration Number: ACTRN12614000836639
• Lead Sponsor: OzStar Therapeutic Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-06
• Study Completion: 2019-09-14
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

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

Inclusion Criteria

I.Have given written informed consent prior to any study-specific procedures.
II.Are between the age of 25 and 65.
III.Diagnosed with T2DM, according to the acceptable criteria in their jurisdiction, for a minimum of 1 year and a maximum of 10 years.
IV.Patients who are on sulphonylurea monotherapy or metformin plus sulphonylurea combination therapy, either at maximum tolerated doses or below, at the time of entry into the trial and have been on sulphonylurea treatment for a period of not less than 6 months prior to entering into the trial, irrespective of duration of metformin intake.
V.The FGL is above 7 mmol/L with HbA1c between 7-10%, as at screening visit.
VI.Did not need any change and/or adjustment in sulphonylurea monotherapy or sulphonylurea plus metformin combination therapy during 12 weeks preceding visit 2 of the study to ensure that the maximal effect of sulphonylurea monotherapy or metformin plus sulphonylurea combination therapy has been observed.
VII.Patient has a BMI of between 25 and 40 kg/m2, as at screening visit.
VIII.No change has been occurred to concomitant medication within the past 12 weeks.

Exclusion Criteria

I.The Patient has been diagnosed with T2DM for less than 1 year OR more than 10 years.
II.The Patient has allergies to anti-diabetes drugs.
III.In the investigator’s opinion, the patient is likely to be non-compliant with the trial medication regimes.
IV.Patients are excluded if they have consumed excessive amounts of uncooked OF/inulin within 4 weeks prior to randomization or will consume excessive amounts of uncooked OF/inulin containing products during their participation in the trial.
A questionnaire listing the OF/inulin containing food products with daily intake limits will be provided to each enrolled patient. The patients who verify consumption of high amounts of these products above the daily intake limit will be excluded.
V.Patients who are taking probiotics supplements 4 weeks prior to randomization or who plans to take probiotic during the trial.
VI.Patients who have a previously known allergy to artichoke or chicory, onion, leek, and other OF/inulin containing products.
A comprehensive list of products containing OF/inulin will be provided to each patient for verification.
VII.Patients who are taking any other non-sulphonylurea oral or parenteral anti-diabetes medications, except metformin, such as, but not limited to, insulin, acarbose, voglibose, DPP4 inhibitors, SGLT-2 inhibitors, GLP-1 mimetics and pioglitazone.
VIII.Patients who are taking a combination of sulphonylurea and other anti-diabetes drugs, except metformin (e.g. pioglitazone or DPP-4 inhibitors) during the past 3 months of screening period.
IX.Patients who are taking warfarin.
X.Patients who plan to practice fasting (i.e. during the Holy month of Ramadan) during participation in the trial.
XI.Female patients of child-bearing potential who are pregnant or test positive for pregnancy at the time of enrolment based on a urine or serum pregnancy test.
XII.Female patients of child-bearing potential who do not agree to use a reliable method of birth control during the study.
XIII.Patients who are unable to participate in the study as judged by the study investigator.
XIV.Patients who have liver dysfunction OR other serious liver disease.
XV.Patients who have diabetes neuropathy or any other neurological conditions.
XVI.Patients who have diabetes nephropathy or any other renal diseases with eGFR<60ml/min and/or overt proteinuria.
XVII.Patients who have serious cardiovascular disease or acute cardiovascular events within the past 6 months.
XVIII.Patients who had heart failure.
XIX.Patients who have cancer.
XX.Patients who have inflammatory bowel disease.
XXI.Patients who have difficulties in managing bloating and passing winds.
XXII.Patients who are bed-ridden or otherwise non-ambulatory.
XXIII.Patients who suffer digestive dysfunction or unexplained nausea, who have irregular or unusual bowel movements.
XXIV.Patient’s with other medical conditions and consumption of other medications will be assessed and is under discretion of the investigator.
XXV.Patients who have prior arrangements to travel longer than 4 weeks during the clinical trial conduct will not be eligible to participate.
XXVI.Patients with concomitant systemic diseases or a recent history of medical conditions which, in the opinion of the site investigator or sponsor medical monitor, would render patients at increased medical risk if they would participate in this study or would interfere with interpretation of the results of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemoglobin A1c[Measured at four time points: <br>At screening visit.<br>At baseline visit (4 weeks after screening visit).<br>At 12 weeks after intervention commencement. <br>At 24 weeks after intervention commencement.<br><br>HbA1c will be measured in whole blood as per instruction described at Roche modular E test.<br>];Fasting Blood Glucose[Measured at four time points: <br>At screening visit.<br>At baseline visit (4 weeks after screening visit).<br>At 12 weeks after intervention commencement. <br>At 24 weeks after intervention commencement.<br><br>Fasting blood glucose will be measured in FIOx tubes as per instruction described at Roche modular E test.]