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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201308000617367 Date registered: 2013/08/14
TRIAL DESCRIPTION
Public title Treatment of the very insulin resistant obese patient with type 2 diabetes
Official scientific title Treatment of the very insulin resistant obese patient with type 2 diabetes. A 24 week prospective randomised open-label treat-to-target exploratory study comparing the GLP-1 analogue exenatide added to Regular insulin U-500 with U-500 alone.
Brief summary describing the background
and objectives of the trial
Severe insulin resistance is rare and difficult to treat. U-500 regular insulin (RI) has been used but reports are retrospective and with small numbers. GLP-1 analogues offer a possible benefit in reducing insulin doses and weight.Objectives: To confirm efficacy of the use of U-500 RI in treating type 2 severe insulin resistant diabetes patients. Ascertain if the addition of exenatide to U-500 may improve glycemic control, reduce insulin dose and prevent or reduce weight gain.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) VIRTUE
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2011-09-30
Actual trial start date 2012-02-29
Anticipated date of last follow up 2012-06-30
Actual date of last follow up 2013-05-23
Anticipated target sample size (number of participants) 30   
Actual target sample size (number of participants) 28   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID
H8O-SZ-O028
N2/19/8/2 (2574) MCC

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Blocked balanced Randomization method prepared by Biostatistician Central Randomization by phone Open-label (masking not used)

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Exenatide 5ug twice daily 24 weeks GLP-1 analogue 15
Control group U-500 Regular Insulin 200 - 750 U twice daily to four times daily 24 weeks 15 Active

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Male or female subjects aged 18-75 years; A history of type 2 diabetes for at least 1 year defined according to the ADA criteria; Total daily insulin requirements of >200 U daily for at least 3 months; HbA1c >7.5 %; Body Mass Index (BMI) >30 kg/m2; Able and willing to understand the protocol and sign informed consent; Able and willing to perform SHGM; Women of childbearing potential must be willing to use adequate contraception for the duration of the study. Pregnancy or planned pregnancy in women of childbearing potential; Use of any of the excluded medication as outlined above; Any known or suspected underlying endocrinopathy that may be aggravating of causing the insulin resistant state (e.g. Cushings syndrome, acromegaly, glucagonoma etc); Any diagnosed chronic inflammatory or systemic autoimmune disorder which may potentiate the insulin resistant state; Any clinically significant disease or disorder, except for those conditions associated with type 2 diabetes, which in the investigators opinion could interfere with the results of the study; Any patients who, in the opinion of the investigator, are unable to conceptualise and understand the differences between and dosages of U-500 and U-100 insulin; Documented significant CVD (unstable angina, heart failure, coronary artery stenting of bypass surgery in past 6 months); The presence of an active carcinoma or other chronic illness, which may interfere with glycaemic control or potential longevity; Severe renal dysfunction (eGFR <30 ml/min); Unable or unwilling to perform SHGM; History of gastroparesis or other significant upper gastrointestinal pathology. 18 Years 75 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/08/08 Pharma Ethics
Ethics Committee Address
Street address City Postal code Country
123 Amcor Road Lyttleton Manor Centurion 0157 South Africa

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Differences in A1C from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences in Fasting plasma glucose from baseline (the start of the study) and at 12 and 24 weeks and between groups; Differences at 12 and 24 weeks in 7-point glucose profiles from baseline (the start of the study) and at 12 and 24 weeks and between groups. Baseline, 12 weeks and 24 weeks Baseline, 12 weeks and 24 weeks Baseline, 12 weeks and 24 weeks
Primary Outcome A1C; Fasting plasma glucose; 7-point glucose profiles Baseline, 12 weeks and 24 weeks Baseline, 12 weeks and 24 weeks Baseline, 12 weeks and 24 weeks
Secondary Outcome Body weight Insulin dose Serum lipid concentrations Hepatic enzymes, SFPT, SGOT, Gamma-GT Baseline, 12 weeks, 24 weeks Baseline, 12 weeks, 24 weeks Baseline, 12 weeks, 24 weeks Baseline, 12 weeks, 24 weeks

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr A Amod Suite 215 Chatsmed Medical Centre 80 Woodhurst Drive Durban 4092 South Africa
Dr LA Distiller Centre of Diabetes & Endocrinology 81 Central Street, Houghton Johannesburg 2198 South Africa
Dr HO Wellmann Suite 1 Vergelegen Medi Clinic Main Road Somerset West 7130 South Africa
Dr L Lombard Kuilsrivier Hospital Medical Suite 206 33 van Riebeeck Street Kuilsrivier 7580 South Africa
Dr H Nortje Unit B1 N1 City Mews C/o Frans Conradie Drive & Marnus Gerber Street Goodwood 7460 South Africa

FUNDING SOURCES
Name of source Street address City Postal code Country
Eli Lilly 1 Petunia Street, Bryanston Johannesburg 2021 South Africa
Merck Serono 1 Friesland drive, Londmeadow Business Estate, Modderfontein Johannesburg South Africa

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr LA Distiller Centre of Diabetes & Endocrinology 81 Central Street, Houghton Johannesburg 2198 South Africa Company

COLLABORATORS
Name Street address City Postal code Country
Retrasol 493 De Jonge Street, Elarduspark Pretoria 0181 South Africa

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Larry A Distiller Larry@cdecentre.co.za +27 (11) 712 6000 +27 (11) 728 6661
Street address City Postal code Country Position / Affiliation
81 Central Street, Houghton Johannesburg 2198 South Africa Principal Investigator
Role Name Email Phone Fax
Public Enquiries Dr Larry A Distiller Larry@cdecentre.co.za 27117126000 +27 (11) 728 6661
Street address City Postal code Country Position / Affiliation
81 Central Street, Houghton Johannesburg 2198 South Africa Public Enquiries
Role Name Email Phone Fax
Scientific Enquiries Dr Larry A Distiller Larry@cdecentre.co.za +27 (11) 712 6000 +27 (11) 728 6661
Street address City Postal code Country Position / Affiliation
81 Central Street, Houghton Johannesburg 2198 South Africa Scientist