Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With Type-2 Diabetes Mellitus

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine whether therapy with once-weekly sc semaglutide in combination with once-daily insulin degludec will be capable of maintaining (or improving) glycemic control, when substituted for multiple daily injections of insulin (MDI), in patients with T2D with adequate glycemic control (≤ 7.5%) on MDI-based regimens (≤ 80 units of insulin per day), vs. further titration of insulin therapy in those continuing MDI. Weight loss, hypoglycemic episodes, and improvement in diabetes-treatment satisfaction will also be assessed between the two groups.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Gender: men and women

2. Ethnicity: all ethnic groups

3. Language: English

4. Age: ≥ 18 to 75 years

5. Type II diabetes

• Currently treated with MDI (basal/bolus regimen) for at least 6 months

• MDI must consist of three or more injections of insulin per day, with at least 2 injections being prandial/rapid-acting insulin

• Prandial insulin restricted to insulin aspart, glulisine, and lispro

• Basal insulin restricted to long acting once-daily analogues (insulin glargine U- 100, insulin degludec (U-100 or U-200), or insulin glargine U-300)

• A1C within 30 days of randomization must be ≤ 7.5% on the present therapy

• Less than or equal to 80 units of total insulin therapy per day

6. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.

Exclusion Criteria:

1. GAD-65 antibody positive

2. Glomerular Filtration Rate <30 mL/min per 1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)

3. Current glucocorticoid therapy

4. Known or suspected allergy to trial medication(s), excipients, or related products, i.e., GLP-1RA therapy or insulin aspart or insulin degludec.

5. The receipt of any investigational drug within 90 days prior to this trial.

6. Previous participation in this trial (Randomized)

7. Mental incapacity or language barrier (non-English speaking)

8. Use of incretin-based therapies <3 months before inclusion in the study

• DPP-4 inhibitors sitagliptin, saxagliptin, linagliptin, alogliptin

• GLP-1RA (exenatide, liraglutide, exenatide LAR, dulaglutide, albiglutide, lixisenatide, semaglutide)

• GLP-1RA/Basal Insulin combination (IGlarLixi, IDegLira)

9. Present use of oral anti-diabetic agents other than metformin. The dose of metformin must be unchanged and stable for the immediate 3 months prior to baseline.

10. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures

11. Personal or family history of medullary thyroid carcinoma

12. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2

13. History of acute or chronic pancreatitis, severe liver disease or LFT's > 2.5X ULN, or severe disease of digestive tract

14. History of bariatric surgery/procedure (gastric banding, gastric sleeve, or Roux-en-Y)

15. Known elevation of serum calcitonin > 50 ng/L