AMBITION 7

Official Title

Efficacy and safety of zenagamtide s.c. once weekly compared to insulin glargine s.c. once daily in participants with type 2 diabetes and increased cardiovascular risk inadequately controlled on 1-3 oral glucose-lower medications.

Study Purpose

An open-label research study investigating how well zenagamtide lowers blood sugars and body weight compared to insulin glargine in people with type 2 diabetes and increased risk of diseases that affect the heart and blood vessels treated with 1-3 other diabetes medication.

Diagnosis

Type 2 Diabetes Obesity Cardiovascular disease (Increased risk of CV defined as prior myocardial infarction, documented coronary artery disease, prior stroke or peripheral artery disease)

Eligibility

Inclusion criteria:

1. Over age 45 years;
2. Type 2 diabetes > 180 days;
3. Treatment with 1 to 3 marketed oral glucose-lowering medications;
4. A1C 7.0% to 10.5% if not taking a sulfonylureas
5. A1C 7.5% to 10.5% if taking sulfonylurea
6. Increased risk of cardiovascular events evidenced by at least one of the following: prior MI, CAD, prior stroke, CKD eGFR >15 and <59 mL/min/1.73m2 or peripheral arterial disease
7. BMI>25 kg/m2

Exclusion criteria:

• Treatment with GLP-1 or any other GLP-1 based treatment, insulin, DPP-4 inhibitors or amylin analogues within 90 days of screening
• Previous or planned bariatric surgery
• Any episodes of diabetic ketoacidosis within 90 days before screening

 

Intervention

There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide, (the treatment being tested) or insulin glargine (a comparator) and which treatment participants get is decided by chance. Participants will follow a dose escalation outlined in study protocol and dose adjustments based on pre-breakfast blood glucose reading.