Adjunctive Therapy in Type 1 Diabetes

Protocol Number: TTP399-302

Sponsor: vTv Therapeutics

There is an unmet medical need to provide people with T1DM treatment options that help to achieve more normal blood glucose levels without an increased risk of hypoglycemia or ketoacidosis.  With this clinical trial, we are studying a glucokinase activator which is an enzyme critical in the metabolism of sugar. Glucokinase levels drop in persons with diabetes which exacerbates the challenges of blood sugar management; however, clinical evidence indicates that this enzyme, TTP399, activates and regulates glucokinase activity decreasing severe or serious hypoglycemic events while maintaining or improving glycemic control, reducing the risk of ketoacidosis.5

Summary of Study Details:

This study takes place over approximately 16 months and involves up to 14 visits to the office with approximately 14 telehealth visits to monitor progress and adjust insulin doses. Visits are more frequent in the beginning and vary from every 2-12 weeks, with the telehealth visits spread throughout the double-blind treatment period. You will be randomly assigned to 1 of 3 treatment arms — 800mg once per day, 800mg twice per day or placebo. You will take 2 tabs with you breakfast and 2 tabs with dinner and the capsules are provided in blister packs.  Your chances of getting active study drug are 66%, placebo 33%.

You will be provided with a glucometer, test strips and a ketone meter with strips. And will also be asked to maintain an eDiary on a study provided Android phone to capture daily study dosing, symptom information and your insulin usage during the Screening and Treatment Periods. During some visits, patient questionnaires will capture how you feel about your health.

Compensation includes a patient stipend of $125 for each in-office visit and $50 for each phone visit.  Total compensation for study participants is $2250-$2450 depending on how much training and adjustment is required. If you discontinue the trial, you will be paid for visits completed.

General Eligibility Criteria:

• A1c <9.5%
• Is currently on CSII (closed-loop systems are prohibited; must be on manual mode for 1 month prior to Screening and for duration of the study) or on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study
• Must have used a CGM device continuously for at least 3 consecutive months prior to the Screening Visit and be willing to continue using their device as prescribed for the duration of the study
• Agrees to use study-provided blinded CGM sensors during five 10-day periods in the study
• Has had at least 1 hypoglycemic event of Level 2 (glucose level <54 mg/dL or <3 mmol/L, [CGM or SMBG confirmed]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to the Screening Visit as determined by the Investigator
• Must not have used GLP-1 (Ozempic, Wegovy, Mounjaro, Victoza, etc) or SGLT-2 (Jardiance, Farxiga, Invokana, etc) or other adjunctive treatments for diabetes other than insulin for 90days prior to Screening. Site will review other prohibited medications that could cause an issue with eligibility.

If interested in learning more, please contact our Research Coordinator, Jamie Sigg, RD,CDCES, CRC at (303) 321-2644 x 214

2 Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and ComplicationsStudy Research Group, Jacobson AM, Musen G. et al. Long term effect of dabetes and its treatment on cognitive function. N Engl J Med. 2007;356(18):1842-1852.

5 Klein KR, Freeman JLR, Dunn I, et al. The SimpliciT1 Study: a randomized, double blind, placebo-controlled Phase 1b/2 adaptive study of TTP399, a hepatoselective glucokinase activator, for adjunctive treatment of type 1 diabetes. Diabetes Care. 2021;44(4):960-968.