Type 2 Diabetes Clinical Trial
Official title:
A Phase 2b, Randomized, Double-Blind, Parallel-Group, Study of Safety and Efficacy of 16 Weeks of Treatment With DIO-902 or DIO-902 Placebo in Addition to Metformin and Atorvastatin or Atorvastatin Placebo in Subjects With Type 2 Diabetes Mellitus (Protocol No. DIO-502)
DiObex Inc. is developing an experimental drug (DIO-902) that is made up of part of the
ketoconazole molecule for the treatment of elevated blood glucose associated with type 2
diabetes mellitus. Ketoconazole (Nizoral®) is a drug available by prescription for the
treatment of fungal infections however DIO-902 is an investigational drug. DIO-902 may lower
blood glucose by lowering levels of a naturally occurring hormone called cortisol. Elevated
cortisol may contribute to the development of type 2 diabetes.
The purpose of this research study is to test the safety of DIO-902 when taken by mouth with
metformin and the cholesterol-lowering drug atorvastatin to determine the type and severity
of any side effects from this treatment.
Other purposes of the study are to see how the treatment affects your blood glucose levels,
cholesterol levels, blood pressure, and waist circumference.
DIO-902 may lower blood glucose by lowering levels of a naturally occurring hormone called
cortisol. Elevated cortisol may contribute to the development of type 2 diabetes. Clinical
trials with ketoconazole have been carried out in patients with type 2 diabetes. Three
clinical trials with DIO-902 have been completed in which 37 patients with type 2 diabetes
and 42 normal healthy volunteers (people without type 2 diabetes) were enrolled. Patients in
these studies received multiple doses of DIO-902. DIO-902 may reduce the level of cortisol
in your blood and therefore may provide you with better control of your blood glucose
levels.
STUDY DRUG ASSIGNMENT
You will be randomized, that is, given a 1 in 4 chance of receiving either 150mg/day of
DIO-902, 300mg/day of DIO-902, 450mg/day of DIO-902 or DIO-902 placebo and a 1 in 2 chance
of receiving 10mg/day of atorvastatin or atorvastatin placebo. The study drug is a tablet
and will be taken by mouth with water. You will take 3 tablets of DIO-902 or DIO-902 placebo
and 1 tablet of atorvastatin or atorvastatin placebo each day. The tablets will be taken at
the same time each day (2200h or 10:00pm). Neither you nor your doctor will know which dose
of DIO-902 or DIO-902 placebo you are on or whether you are taking the atorvastatin or
atorvastatin placebo. If necessary, your doctor has a way of finding out which dose you were
assigned.
Atorvastatin
If you are taking any cholesterol-lowering drugs, these drugs must be discontinued on the
day prior to the Pre-Treatment Visit (Week -4) and for the duration of the study. At Visit 1
(Week 0) you will be assigned to DIO-902 or DIO-902 placebo and to either atorvastatin or
atorvastatin placebo. You will continue to take the assigned drug until Study Visit 4 (Week
8). At Study Visit 4 (Week 8) all patients will begin taking atorvastatin through the
remainder of the study. Your DIO-902 or DIO-902 placebo assignment will remain the same.
Atorvastatin tablets will be supplied to you until Study Visit 6 (Week 16). At this visit
you will be given a prescription for a 28 day supply of atorvastatin 10mg.day to last until
Study Visit 7 (Week 20).
There will a total of 9 study visits. At each visit all or some of the following will occur:
blood and urine samples will be taken, physical exam, assessment of side effects, and ECG
will be performed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05219994 -
Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum
|
N/A | |
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Completed |
NCT02284893 -
Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone
|
Phase 3 | |
Completed |
NCT04274660 -
Evaluation of Diabetes and WELLbeing Programme
|
N/A | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Active, not recruiting |
NCT05566847 -
Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Completed |
NCT04965506 -
A Study of IBI362 in Chinese Patients With Type 2 Diabetes
|
Phase 2 | |
Recruiting |
NCT06115265 -
Ketogenic Diet and Diabetes Demonstration Project
|
N/A | |
Active, not recruiting |
NCT03982381 -
SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
|
Phase 4 | |
Completed |
NCT04971317 -
The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages
|
N/A | |
Completed |
NCT04496154 -
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
|
N/A | |
Completed |
NCT04023539 -
Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05530356 -
Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
|
||
Completed |
NCT03960424 -
Diabetes Management Program for Hispanic/Latino
|
N/A | |
Completed |
NCT04097600 -
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets
|
Phase 1 | |
Completed |
NCT05378282 -
Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
|
||
Active, not recruiting |
NCT06010004 -
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
|
Phase 3 | |
Completed |
NCT03653091 -
Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes
|
N/A |