Study Comparing Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)

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Study Comparing Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)

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Eligibility

Inclusion Criteria

1. Male or female ≥ 18 years of age
2. Diagnosis of T2DM ≥ 180 days
3. HbA1c 7.0-11.0%
4. Insulin naïve
5. Stable daily dose ≥ 90 days if anti-diabetic drug(s) or combination regimen(s)
– Metformin alone or in combo ≥ 1500mg a day or max tolerated
– any other oral anti-diabetic medications
6. BMI ≤ 40 kg/m2

Exclusion Criteria

1. diabetic ketoacidosis within 90 days
2. MI, stroke, hospitalization for unstable angina or TIA within 180 days
3. NYHA Class IV HF
4. Current use of medications that affect weight (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
5. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy

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