Type 2 Diabetes Mellitus
Conditions
Brief summary
This is a phase 2 study designed to evaluate the efficacy of daily (QD) oral RGT001-075 GLP1 receptor agonist relative to placebo after up to 16 weeks of double-blind treatment as determined by mean change from baseline in HbA1c in adult patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control with diet and exercise and stable metformin treatment.
Interventions
DRUGRGT001-075
Oral GLP1 Receptor Agonist
OTHERPlacebo
Placebo comparator
Sponsors
Regor Pharmaceuticals Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes that has been treated with lifestyle modification and a stable dose of metformin ≥1000 mg/day (or maximum tolerated dose) for at least 3 months at the time of Screening * Screening HbA1c 7.0-10.5% * Male or female, age 18-75 years * Screening BMI 24.5 - 40 kg/m2 * Either surgically sterile, abstinent, or willing to use a highly effective method of contraception for the entirety of the study, and not be pregnant or lactating if a woman of child-bearing potential
Exclusion criteria
* Has received within the preceding 3 months prior to Screening, another approved or investigational oral or injectable antidiabetic medication (including, but not limited to sulfonylureas, dipeptidyl peptidase-4 inhibitor \[DPP-4i\], sodium-glucose cotransport 2 inhibitors, alphaglucosidase inhibitors, meglitinides, thiazolidinediones) or insulin in addition to metformin therapy * Has active GI disease including acute or chronic pancreatitis, severe gastroparesis or chronic malabsorption, inflammatory bowel disease, symptomatic gallbladder or biliary disease, known unstable liver disease, a diagnosis of fibrotic nonalcoholic steatohepatitis (NASH), Gilbert's syndrome, or obvious clinical signs or symptoms of liver disease including chronic active hepatitis B or C, or primary biliary cirrhosis, or elevated alanine aminotransferase (ALT) levels at Screening * Has any history of myocardial infarction (MI), unstable angina, coronary artery bypass graft, percutaneous coronary therapeutic intervention, transient ischemic attack, stroke, or decompensated congestive heart failure within previous 6 months prior to Screening * Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 * Has active proliferative diabetic retinopathy or macular edema * Has a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid cancer * Has an active or untreated malignancy or has been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \<5 years prior to screening * Has evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at screening * Has had a significant change in weight, defined as a gain or loss of at least 5% body weight in the 3 months prior to screening * Has been treated or plan to be treated with drugs or devices or surgery that promote weight loss within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline to end of treatment in the modified intent-to-treat population | up to 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety clinical laboratories - serum calcium absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum lipase absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum amylase absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - eGFR (calculated) absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - fasting serum glucose absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum albumin absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum total protein absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - fasting serum total cholesterol absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - fasting serum HDL-C absolute and percent change from baseline | up to 16 weeks |
| Safety clinical laboratories - fasting serum triglycerides absolute and percent change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum total bilirubin absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum direct bilirubin absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum alkaline phosphatase absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum alanine aminotransferase absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum aspartate aminotransferase absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum blood urea nitrogen absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum creatinine absolute change from baseline | up to 16 weeks |
| Change in fasting plasma glucose from baseline to end of treatment in the modified intent-to-treat population | up to 16 weeks |
| Safety clinical laboratories - serum uric acid absolute change from baseline | up to 16 weeks |
| Change in body mass index from baseline to end of treatment in the modified intent-to-treat population | up to 16 weeks |
| Change in waist circumference from baseline to end of treatment in the modified intent-to-treat population | up to 16 weeks |
| Change in mean blood lipids including triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from baseline to end of treatment in the modified intent-to-treat population | up to 16 weeks |
| Percentages of patients achieving HbA1c <6.0%, <6.5%, and/or <7.0% | up to 16 weeks |
| Percentages of patients achieving ≥5% and/or ≥10% greater body weight loss | up to 16 weeks |
| Incidence of treatment-emergent adverse events (TEAE)s, serious adverse events (SAE)s, deaths, and adverse events (AE)s leading to study discontinuation | up to 16 weeks |
| Vital signs - Systolic blood pressure (mmHg) absolute change from baseline | up to 16 weeks |
| Vital signs - Diastolic blood pressure (mmHg) absolute change from baseline | up to 16 weeks |
| Vital signs - Heart rate (beats/minute) absolute change from baseline | up to 16 weeks |
| Vital signs - Body weight (kg) absolute and percent change from baseline | up to 16 weeks |
| Safety clinical laboratories - complete blood count absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum sodium absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum potassium absolute change from baseline | up to 16 weeks |
| Safety clinical laboratories - fasting serum LDL-C absolute and percent change from baseline | up to 16 weeks |
| Safety clinical laboratories - serum calcitonin absolute change from screening | up to 16 weeks |
| ECG interval change from baseline absolute and categorical outliers >450ms | up to 16 weeks |
| Proportion of patients who report AEs of Special Interest (AESI) including GI intolerability, hypoglycemia, drug hypersensitivity reactions, acute pancreatitis, thyroid C-cell hyperplasia and C-cell neoplasms, and cardiovascular (CV) events | up to 16 weeks |
| Change in mean body weight (absolute and %) from baseline to end of treatment in the modified intent-to-treat population | up to 16 weeks |
Countries
United States
Outcome results
None listed