A randomised, placebo-controlled, double-blind trial to assess the safety and glucose-lowering efficacy of VVP808 in participants with Type 2 diabetes.

Phase 2

Recruiting

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

• Registration Number: ACTRN12609000634279
• Lead Sponsor: Verva Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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);

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

• Study Type: Interventional
• Study Design: Not specified