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Anti-diabetic agent

AZD5004 for Type 2 Diabetes (SOLSTICE Trial)

Phase 2

Recruiting

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

Must not have

History of acute or chronic pancreatitis

Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to weeks 4, 12, 16 and 26

Summary

This trial is testing a new drug called AZD5004 in adults with type 2 diabetes to see if it is effective and safe compared to a placebo and another diabetes medication.

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 below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had pancreatitis before.

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I have had or plan to have weight loss surgery or a device fitted.

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I have type 1 diabetes or a history of severe diabetes complications.

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I have had serious eye problems due to diabetes that needed immediate treatment.

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 4, 12, 16 and 26 for reporting.

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 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220

26%

Nasopharyngitis

Constipation

Influenza

Diabetic retinopathy

Nausea

Gastrooesophageal reflux disease

Back pain

Upper respiratory tract inflammation

Abdominal discomfort

Vomiting

Diarrhoea

Cardiac ablation

Herpes zoster

Ischaemic cerebral infarction

Acute myocardial infarction

Appendicitis

Large intestine polyp

Peritonitis

Sudden hearing loss

Rectal adenocarcinoma

Spinal operation

100%

80%

60%

40%

20%

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