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Trial registered on ANZCTR


Registration number
ACTRN12609000634279
Ethics application status
Approved
Date submitted
24/07/2009
Date registered
29/07/2009
Date last updated
6/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, placebo-controlled, double-blind trial to assess the safety and glucose-lowering efficacy of VVP808 in participants with Type 2 diabetes.
Scientific title
A randomised, placebo-controlled, double-blind trial to assess the safety and glucose-lowering efficacy of VVP808 compared to placebo in participants with Type 2 diabetes.
Secondary ID [1] 923 0
VVP808-002
(Verva Pharmaceutical's protocol ID)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 237255 0
Condition category
Condition code
Metabolic and Endocrine 239575 239575 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
VVP808
dose: 40 mg twice a day
duration: 24 weeks
mode of administration: oral (capsule)
Intervention code [1] 236941 0
Treatment: Drugs
Comparator / control treatment
Placebo (microcrystalline cellulose)
Dose: 40 mg twice a day
duration: 24 weeks
mode of administration: oral (capsule)
Control group
Placebo

Outcomes
Primary outcome [1] 238369 0
The safety and tolerability of 40 mg VVP808 administered twice a day, compared to placebo, in subjects with Type 2 diabetes as determined by the incidence of acidosis based on Venous Blood Gas (VBG) parameters.
Timepoint [1] 238369 0
24 weeks from randomisation.
Th safety and tolerability primary outcome will be assessed continuously throughout the study (evey study visit).
Primary outcome [2] 238370 0
The efficacy of VVP808 compared to placebo, in subjects with Type 2 diabetes in improving glucose control as quantified by glycated hemoglobin (HbA1c).
Timepoint [2] 238370 0
24 weeks following randomisation. The efficacy primary outcome will be assessed at weeks 12, 18 and 24.
Secondary outcome [1] 244815 0
The safety and tolerability of 40 mg of VVP808 administered twice a day compared to placebo in subjects with Type 2 diabetes as assessed by biochemistry parameters and adverse event reporting. Potential adverse events include:
loss of appetite,
taste alteration
gastrointestinal disturbances such as gas, flatulence, indigestion, abdominal discomfort, nausea, vomiting, and diarrhoea.
a tingling feeling in the hands and feet; hearing problems or buzzing in the ears; tiredness; excessive passage of urine; acidosis (accumulation of acid in the blood),and transient nearsightedness.
Timepoint [1] 244815 0
24 weeks following randomisation.
The safety and tolerability secondary endpoint will be assess continuously during the study (at every study visit).
Secondary outcome [2] 244816 0
The efficacy of 24-weeks treatment with VVP808, compared to placebo, in subjects with Type 2 diabetes in improving:
Fasting blood glucose;
Timepoint [2] 244816 0
24 weeks frollowing randomisation.
The efficacy secondary endpoint will be assessed at weeks 12, 18 and 24.
Secondary outcome [3] 257007 0
The efficacy of 24-weeks treatment with VVP808, compared to placebo, in subjects with Type 2 diabetes in improving:
The proportion of subjects achieving recommended HbA1c and fasting blood glucose (FBG) targets;
Timepoint [3] 257007 0
24 weeks frollowing randomisation.
The efficacy secondary endpoint will be assessed at weeks 12, 18 and 24.
Secondary outcome [4] 257008 0
The efficacy of 24-weeks treatment with VVP808, compared to placebo, in subjects with Type 2 diabetes in improving:
Subject measured capillary blood glucose profiles recorded on a memory-chip glucometer;
Timepoint [4] 257008 0
24 weeks frollowing randomisation.
The efficacy secondary endpoint will be assessed daily during the study.
Secondary outcome [5] 257009 0
The efficacy of 24-weeks treatment with VVP808, compared to placebo, in subjects with Type 2 diabetes in improving:
Subject reported outcome as assessed by the SF-12 and DiabMedSat questionnaires;
Subject risk factors (body weight, waist circumference, blood pressure, lipid profile and microalbuminuria).
Timepoint [5] 257009 0
24 weeks frollowing randomisation.
The efficacy secondary endpoint will be assessed at the end of the study (week 24).

Eligibility
Key inclusion criteria
Participants with Type 2 diabetes mellitus; HbA1c between 6.5 and 8.5%, inclusive at screening; Body Mass Index (BMI) less than or equal to 40 kg/m2 and a total body weight greater than 50kg);
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current treatment with any hypoglycaemic drug other than metformin; Any systemic treatment with products, which in the Investigator’s opinion, could interfere with glucose metabolism (eg systemic glucocorticoids) within 3 months prior to randomisation; Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, hepatic (liver function tests, more than 200% upper limit of the reference range, except yGlutamuyl transferase), pulmonary, cardiovascular, neurological, genitourinary, endocrine, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product; Current or past history of acidosis; Current hypokalaemia; hyponatraemia; glomerular filtration rate < 60 mL/minute; or elevated plasma lactate; Adrenal insufficiency; Hypersensitivity to, or persons considered at increase risk of hypersensitivity to, methazolamide or acetazolamide, sulfonamides or sulfonamide derivatives, or any excipients in the formulation. (Cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible); History of urolithiasis; History of narrow-angle glaucoma; 12-lead electrocardiogram (ECG) demonstrating QTc > 450 msec at screening; Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to the first dose of trial medication until completion of follow-up procedures;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers will be assigned a unique 3 digit identification number (Screening Number) as they are screened for the trial.
On Day 0, Participants who are deemed eligible for randomisation will receive a randomisation number, consisting of a two-digit number. Randomisation numbers will be allocated sequentially starting at 01 as each participant is enrolled into the study. Participants will be identified by both the screening number and the randomisation number for the duration of the study.

The Participants will be randomised to receive VVP808 or placebo in a 1:1 ratio. Treatments will be administered according to the randomised sequence under the control of the unblinded pharmacist at the Geelong Hospital Pharmacy Department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code will be developed by a statistician - simple randomisation by using a randomization table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237332 0
Commercial sector/Industry
Name [1] 237332 0
Verva Pharmaceuticals
Address [1] 237332 0
Level 4, 199 Moorabool St
Geelong VIC 3220
Country [1] 237332 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Verva Pharmaceuticals
Address
Level 4, 199 Moorabool St
Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 236818 0
None
Name [1] 236818 0
Address [1] 236818 0
Country [1] 236818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239444 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 239444 0
The Geelong Hospital
PO Box 281
Geelong VIC 3220
Ethics committee country [1] 239444 0
Australia
Date submitted for ethics approval [1] 239444 0
04/08/2009
Approval date [1] 239444 0
23/11/2009
Ethics approval number [1] 239444 0
09/82
Ethics committee name [2] 258303 0
Eastern Health Research & Ethics Committee
Ethics committee address [2] 258303 0
5 Arnold Street
BOX HILL VIC 3128
AUSTRALIA
Ethics committee country [2] 258303 0
Australia
Date submitted for ethics approval [2] 258303 0
26/10/2009
Approval date [2] 258303 0
11/12/2009
Ethics approval number [2] 258303 0
E41/1910
Ethics committee name [3] 258304 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 258304 0
Henry Buck Building
Austin Hospital
145 Studley Rd
Heidelberg VIC 3081
Ethics committee country [3] 258304 0
Australia
Date submitted for ethics approval [3] 258304 0
17/11/2009
Approval date [3] 258304 0
Ethics approval number [3] 258304 0
03801

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29900 0
Address 29900 0
Country 29900 0
Phone 29900 0
Fax 29900 0
Email 29900 0
Contact person for public queries
Name 13147 0
Alana Sarah
Address 13147 0
Department of Clinical and Biomedical Sciences
The Geelong Hospital
PO Box 281
Geelong VIC 3220
Country 13147 0
Australia
Phone 13147 0
+61 3 5226 7621
Fax 13147 0
+61 3 5260 3306
Email 13147 0
alanas@barwonhealth.org.au
Contact person for scientific queries
Name 4075 0
Prof. Geoff Nicholson
Address 4075 0
Department of Clinical and Biomedical Sciences
The Geelong Hospital
PO Box 281
Geelong VIC 3220
Country 4075 0
Australia
Phone 4075 0
+61 3 5226 7972
Fax 4075 0
+61 3 5222 2420
Email 4075 0
geoffn@barwonhealth.org.au

No information has been provided regarding IPD availability
Summary results
No Results