A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults With Type 2 Diabetes Mellitus.
Overview
- Phase
- Phase 2
- Intervention
- AZD5004
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- AstraZeneca
- Enrollment
- 406
- Locations
- 98
- Primary Endpoint
- Change in HbA1c
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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/m
- •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.
Arms & Interventions
Arm 1
Participants will receive xx mg once daily dose of AZD5004
Intervention: AZD5004
Arm 2
Participants will receive xx mg once daily dose of AZD5004
Intervention: AZD5004
Arm 3
Participants will receive xx mg once daily dose of AZD5004
Intervention: AZD5004
Arm 4
Participants will receive xx mg once daily dose of AZD5004
Intervention: AZD5004
Arm 5
Participants will receive xx mg once daily dose of AZD5004
Intervention: AZD5004
Arm 6
Participants will receive xx mg once daily dose of AZD5004
Intervention: AZD5004
Arm 7
Participants will receive once daily dose of Semaglutide as active comparator
Intervention: Semaglutide
Arm 8
Participants will receive matching placebo for each AZD5004 arm
Intervention: Placebo (placebo matching AZD5004 film-coated tablet)
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on glycemic control
Secondary Outcomes
- Change in fasting glucose(Baseline to Weeks 4, 12, 16 and 26)
- Achievement of HbA1c ≤ 6.5%(Week 26)
- Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%(Week 26)
- Percent change in body weight(Baseline to Week 26)
- Absolute change in body weight(Baseline to Week 26)
- Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction(Baseline to Week 26)