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Anti-diabetic agent
Arm 1 for Type 2 Diabetes (SOLSTICE Trial)
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults ≥ 18 years of age.
Diagnosed with T2DM for at least 6 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 4, 12, 16 and 26
Awards & highlights
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.
Who is the study for?
This trial is for adults with type 2 diabetes who have not achieved adequate blood sugar control. Participants should be able to take oral medication and commit to the study for 26 weeks. Specific medical conditions or treatments that could interfere with the study are reasons for exclusion.
What is being tested?
The trial tests a new once-daily pill, AZD5004, against a placebo (a dummy pill) and Semaglutide, an existing diabetes medication. The goal is to see if AZD5004 is effective in controlling blood sugar levels over a period of 26 weeks.
What are the potential side effects?
Potential side effects may include gastrointestinal issues like nausea or diarrhea, risk of low blood sugar events, possible allergic reactions, kidney problems, and other side effects typically associated with diabetes medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 4, 12, 16 and 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 4, 12, 16 and 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in HbA1c
Secondary study objectives
Absolute change in body weight
Change in fasting glucose
Percent change in body weight
+2 moreSide effects data
From 2018 Phase 3 trial • 458 Patients • NCT0301522026%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg
Trial Design
8Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm 6Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group II: Arm 5Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group III: Arm 4Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group IV: Arm 3Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group V: Arm 2Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group VI: Arm 1Experimental Treatment1 Intervention
Participants will receive xx mg once daily dose of AZD5004
Group VII: Arm 7Active Control1 Intervention
Participants will receive once daily dose of Semaglutide as active comparator
Group VIII: Arm 8Placebo Group1 Intervention
Participants will receive matching placebo for each AZD5004 arm
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,306 Previous Clinical Trials
288,625,084 Total Patients Enrolled
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