Diabetes Mellitus, Type 2
Conditions
Brief summary
This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator.
Detailed description
This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.
Interventions
DRUGPlacebo (placebo matching AZD5004 film-coated tablet)
Placebo film-coated tablet (matching AZD5004)
DRUGAZD5004
AZD5004 film-coated tablet, once daily during 26 weeks
DRUGSemaglutide
3-14 mg tablets of Semaglutide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Masking (blinding) applies to patients and investigators involved in AZD5004 and placebo arms, however not in active comparator arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults ≥ 18 years of age. Diagnosed with T2DM for at least 6 months. HbA1c ≥ 7.0% and ≤ 10.5% managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening. Body mass index of ≥ 23 kg/m2. Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).
Exclusion criteria
Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment. Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Received medication for weight loss within the last 3 months prior to screening. Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract. Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier). History of acute or chronic pancreatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | Baseline to Week 26 | To evaluate the effect of AZD5004 versus placebo on glycemic control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of HbA1c ≤ 6.5% | Week 26 | To evaluate of the effect of AZD5004 versus placebo on HbA1c |
| Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0% | Week 26 | To evaluate the effect of AZD5004 versus placebo on HbA1c |
| Change in fasting glucose | Baseline to Weeks 4, 12, 16 and 26 | To evaluate the effect of AZD5004 versus placebo on fasting glucose |
| Absolute change in body weight | Baseline to Week 26 | To evaluate the effect of AZD5004 versus placebo on weight loss |
| Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction | Baseline to Week 26 | To evaluate the effect of AZD5004 versus placebo on weight loss |
| Percent change in body weight | Baseline to Week 26 | To evaluate the effect of AZD5004 versus placebo on weight loss |
Countries
Canada, Germany, Hungary, Japan, Poland, Slovakia, Spain, United Kingdom, United States
Outcome results
None listed